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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001412-65 | EudraCT Number |
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Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open | Experimental | Pregabalin open label flexible dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Pregabalin administered as either capsule or liquid oral formulations. Subjects <4 years of age at Visit 1 will receive study medication 3 times daily (TID) in equally divided doses. Subjects who are ≥4 years of age at Visit 1 will receive study medication twice daily (BID) in equally divided doses. Children less than 17 years of age will receive from 2.5 mg/kg/day to 10.0 mg/kg/day (maximum 600 mg/day. Adults 17 and older will receive from 150 mg/day to 600 mg/day. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 28 days after last dose of study drug (up to 13 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. | Baseline (Day 1) up to 13 Months |
| Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months | Physical examination assessed: general appearance, dermatological, head and eyes, ears, nose, mouth, and throat, pulmonary, cardiovascular, abdominal, genitourinary (optional), lymphatic, musculoskeletal/extremities. Neurological examination assessed: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation, coordination and gait. Investigator judged clinically significant change from baseline in physical and neurological examination findings. | Baseline up to 12 Months |
| Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities | Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) >=30 millimeter of mercury (mmHg); maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) >=20 mmHg. | Baseline up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Number of participants with C-CASA code 4 are reported. C-SSRS responses mapping to C-CASA suicidal ideation code 4 are as follows: "Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with any methods (not plan) without intent to act", "active suicidal ideation with some intent to act, without specific plan", "active suicidal ideation with some intent to act, without specific plan". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Neurosciences | Tucson | Arizona | 85718 | United States | ||
| Arkansas Children's Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Reporting arms are on basis of pediatric and adult participants who consented to continue from previous studies receiving either pregabalin or placebo and pediatric participants who directly enrolled in this study. Previous studies- A0081041 (NCT01389596), A0081042 (NCT02072824), A0081105 (NCT01747915).
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin: Previous and Current | Pediatric and adult participants with partial onset seizures (POS) and primary generalized tonic-clonic (PGTC) seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered in 3 equally divided doses per day (TID) when age less than (<) 4 years and in 2 equally divided doses per day (BID) when age greater than or equal to (>=) 4 years. Pediatric participants with body weight >=30 kilogram (kg) received pregabalin 2.5 milligram per kilogram per day (mg/kg/day) as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 milligram per day (mg/day) as liquid oral solution/oral capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 7, 2014 | Jan 31, 2020 |
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| Number of Participants With Tanner Staging Evaluation at Baseline | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). | Baseline (Day 1) |
| Number of Participants With Tanner Staging Evaluation at Month 12 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). | Month 12 |
| Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months | In this outcome measure number of participants with increase and decrease of >=7% in body weight, from baseline up to 12 months are reported. | Baseline up to 12 Months |
| Absolute Values for Body Height at Baseline | Baseline |
| Absolute Values for Body Height at Month 12 | Month 12 |
| Number of Participants With Incidence of Laboratory Abnormalities | Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell(RBC) count: <0.8*lower limit of normal(LLN), platelet: <0.5*LLN/greater than (>)1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN/>1.5*ULN, lymphocyte, neutrophil- absolute/%:<0.8*LLN/>1.2*ULN, basophil, eosinophil, monocyte- absolute/%:>1.2*ULN; total/direct/indirect bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:> 3.0*ULN, total protein, albumin: <0.8*LLN/>1.2*ULN; thyroxine, thyroid stimulating hormone <0.8*LLN/>1.2*ULN; cholesterol, triglycerides:> >1.3*ULN; blood urea nitrogen, creatinine:>1.3*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium: <0.9*LLN or >1.1*ULN; glucose <0.6*LLN/>1.5*ULN, creatine kinase>2.0*ULN; urine (specific gravity <1.003/>1.030, pH <4.5/>8, glucose, ketones, protein: >=1, WBC, RBC:>=20, bacteria >20, hyaline casts/casts >1); prothrombin (PT), PT international ratio>1.1*ULN. | Baseline up to 12 Months |
| Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Categories for which data is reported are: 1) maximum (max) PR interval increase from baseline (IFB) (millisecond [msec]) percent change (PctChg) >=25/50%; 2) maximum QRS complex increase from baseline (msec) PctChg>=50%; 3) maximum QTcB interval (Bazett's correction) increase from baseline (msec): change >=30 to <60; change >=60; 4) maximum QTcF interval (Fridericia's correction) increase from baseline (msec): change >=30 to <60; change >=60. 'PctChg>=25/50%': >= 25% increase from baseline when baseline ECG parameter is > 200 msec, and is >= 50% increase from baseline when baseline ECG parameter is non-missing and <=200 msec. | Baseline up to 12 Months |
| 28-Days Seizure Rate at Week 1 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. | Week 1 |
| 28-Days Seizure Rate at Month 1 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. | Month 1 |
| 28-Days Seizure Rate at Month 2 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. | Month 2 |
| 28-Days Seizure Rate at Month 4 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. | Month 4 |
| 28-Days Seizure Rate at Month 6 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. | Month 6 |
| 28-Days Seizure Rate at Month 9 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. | Month 9 |
| 28-Days Seizure Rate at Month 12/Early Termination | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. | Month 12/Early Termination |
| Baseline (Day 1), Post-baseline on Day 1 up to 12 Months |
| Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Number of participants with C-CASA code 1 or 2 or 3 are reported. C-SSRS responses mapping to C-CASA suicidal behavior codes 1, 2, or 3 are as follows: (1) completed suicide; (2) suicide attempt (response of "Yes" on "actual attempt"); (3) preparatory acts toward imminent suicidal behavior ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"). | Baseline (Day 1), Post-baseline up to 12 Months |
| Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task | CogState brief battery consisted of 2 tasks- detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded "yes" using a response button with dominant hand. Participants had to "respond as fast and as accurately as possible." Detection task: measured simple reaction time to assess psychomotor function. Participant pressed a "YES" response key as soon as they detected an event (ie, a card turning face up presented in the center of the computer screen). A participant's RCI was calculated by dividing the change from individual baseline score by ([square root 2] times WSD), where WSD is within-subject standard deviation from Cogstate detection task normative data. Improvement in cognition when RCI <=-1.65, decline in cognition when RCI =>1.65. | Month 12 |
| Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task | CogState brief battery consisted of 2 tasks-detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded "yes" using a response button with dominant hand. Participants had to "respond as fast and as accurately as possible." Pediatric identification task: measured choice reaction time to assess visual attention. An event (a card turning face up) occurred in center of computer screen and participant decided if event met a predefined and unchanging criterion (is the color of the card black?); answered "YES" if criterion was met. A participant's RCI was calculated by dividing the change from individual baseline score by ([square root 2] times WSD),WSD=within-subject standard deviation from Cogstate task normative data. Improvement in cognition: RCI <=-1.65, decline in cognition: RCI =>1.65. | Month 12 |
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Axcess Medical Research | Loxahatchee Groves | Florida | 33470 | United States |
| Laszlo J. Mate, M.D., P.A. | North Palm Beach | Florida | 33408 | United States |
| Pediatric Epilepsy Center Of Central Florida | Orlando | Florida | 32819 | United States |
| Pediatric Neurology, PA | Orlando | Florida | 32819 | United States |
| Tallahassee Neurological Clinic | Tallahassee | Florida | 32308 | United States |
| Pediatric Epilepsy and Neurology Specialists, PA | Tampa | Florida | 33609 | United States |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | United States |
| Josephson Wallack Munshower Neurology P.C. | Indianapolis | Indiana | 46237 | United States |
| Kosair Children's Hospital | Louisville | Kentucky | 40202 | United States |
| University of Louisville Physicians | Louisville | Kentucky | 40202 | United States |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| Ohio Clinical Research Partners, LLC | Canton | Ohio | 44718 | United States |
| The children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15224 | United States |
| Dallas Pediatric Neurology Associates | Dallas | Texas | 75230 | United States |
| Road Runner Research, Ltd. | San Antonio | Texas | 78249 | United States |
| Rainier Clinical Research Center, Inc. | Renton | Washington | 98057 | United States |
| GU Republican Scientific and Practical Center Mother and Child | Minsk | 220053 | Belarus |
| UZ Vitebsk Regional Childrens Clinical Centre | Vitebsk | 210015 | Belarus |
| UZ Vitebsk Regional Childrens Clinical Centre | Vitebsk | 210022 | Belarus |
| Hopital Universitaire Des Enfants Reine Fabiola | Brussels | Brussels Capital | 1020 | Belgium |
| Hospital Erasme | Brussels | Brussels Capital | 1070 | Belgium |
| UZ Brussel - Campus Jette - Pediatric Neurology | Brussels | Brussels Capital | 1090 | Belgium |
| University Clinical Center Sarajevo | Sarajevo | Canton Sarajevo, Bosnia and Herzegovina | 71000 | Bosnia and Herzegovina |
| University Clinical Hospital Mostar | Mostar | Herzegovina-neretva Canton | 88000 | Bosnia and Herzegovina |
| Public Health Institution Hospital "Dr. Mladen Stojanovic" | Prijedor | Republika Srpska | 79101 | Bosnia and Herzegovina |
| "Multiprofile Hospital for Active Treatment Puls" AD | Blagoevgrad | 2700 | Bulgaria |
| UMHAT Dr. Georgi Stranski Ltd. | Pleven | 5800 | Bulgaria |
| MHAT Central Onco Hospital OOD | Plovdiv | 4000 | Bulgaria |
| UMHAT "Sveti Georgi" Ltd., Pediatric Clinic | Plovdiv | 4000 | Bulgaria |
| MHATNP Sveti Naum EAD | Sofia | 1113 | Bulgaria |
| DCC Sveta Anna - Sofia\ Neurological room | Sofia | 1784 | Bulgaria |
| The First Bethune Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Shanghai Huashan Hospital | Shanghai | Shanghai Municipality | 201100 | China |
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
| Fakultni nemocnice Brno - Detska nemocnice | Brno - Cerna Pole | 613 00 | Czechia |
| Fakultni nemocnice v Motole | Prague | 150 06 | Czechia |
| Hopital Raymond Poincare | Garches | 92380 | France |
| CHRU de Rennes - Hopital Pontchaillou | Rennes | 35033 | France |
| Hopitaux Universitaire de Strasbourg - Hopital Hautepierre | Strasbourg | 67098 | France |
| Universitaetsklinikum Jena | Jena | Thuringia | 07747 | Germany |
| General Children's Hospital of Athens "P&A Kyriakou" | Athens | 11527 | Greece |
| General Children's Hospital Penteli | Athens | 15236 | Greece |
| Dr. Kenessey Albert Kórház és Rendelőintézet | Balassagyarmat | H-2660 | Hungary |
| Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika/ | Budapest | 1083 | Hungary |
| Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak | Budapest | H-1023 | Hungary |
| Szent Margit Korhaz | Budapest | H-1032 | Hungary |
| Heim Pal Gyermekkorhaz, Neurologiai Osztaly | Budapest | H-1089 | Hungary |
| Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia | Budapest | H-1146 | Hungary |
| Pest Megyei Flor Ferenc Korhaz, Neurologiai Osztaly | Kistarcsa | 2143 | Hungary |
| Pecsi Tudomanyegyetem Klinikai Kozpont | Pécs | 7623 | Hungary |
| Mangala Hospital & Mangala Kidney Foundation | Mangalore | Karnataka | 575003 | India |
| Getwell Hospital and Research Institute | Dhantoli, Nagpur | Maharashtra | 440012 | India |
| KEM Hospital Research Centre | Pune | Maharashtra | 411 011 | India |
| Bnai Zion Medical Center | Haifa | 3104802 | Israel |
| Pharmacy of Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| A.O.U. Ospedali Riuniti di Ancona - Presidio Ospedaliero G. Salesi - S.O.D. Farmacia | Ancona | 60123 | Italy |
| A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi | Ancona | 60123 | Italy |
| Azienda Ospedaliero-Universitaria Meyer | Florence | 50139 | Italy |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS | Pavia | 27100 | Italy |
| American University of Beirut Medical Center | Beirut | Lebanon |
| Saint George Hospital - University Medical Center | Beirut | Lebanon |
| Hospital Raja Perempuan Zainab II | Kota Bharu | Kelantan | 15586 | Malaysia |
| Hospital Raja Permaisuri Bainun | Ipoh | Perak | 30990 | Malaysia |
| Hospital Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Pzu Neuron | Bijelo Polje | 84000 | Montenegro |
| Cebu Doctors' University Hospital | Cebu City | CEBU | 6000 | Philippines |
| Perpetual Succour Hospital | Cebu City | 6000 | Philippines |
| Philippine Children's Medical Center | Diliman, Quezon City | 1105 | Philippines |
| Manila Doctors Hospital | Manila | 1000 | Philippines |
| Metropolitan Medical Center | Manila | 1003 | Philippines |
| University of Santo Tomas Hospital | Manila | 1008 | Philippines |
| Capitol Medical Center Inc. | Quezon City | 1100 | Philippines |
| St. Luke's Medical Center | Quezon City | 1102 | Philippines |
| COPERNICUS Podmiot Leczniczy Sp z o.o. | Gdansk | 80-803 | Poland |
| Klinika Neurologii Rozwojowej | Gdansk | 80-952 | Poland |
| NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski | Katowice | 40-123 | Poland |
| Nzoz Novo Med | Katowice | 40-650 | Poland |
| Gabinet lekarski Neurologii I Leczenia padaczki | Kielce | 25-316 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej "HIPOKRATES-II" Sp. z o.o. | Krakow | 31-223 | Poland |
| Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie | Lublin | 20-090 | Poland |
| Katedra i Klinika Neurologii Wieku Rozwojowego | Poznan | 60-355 | Poland |
| NZOZ "IGNIS" Dr. n. med. Alicja Lobinska | Świdnik | 21-040 | Poland |
| Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka, | Wroclaw | 54-049 | Poland |
| Spitalul clinic de copii Dr. Victor Gomoiu | Bucharest | 022113 | Romania |
| Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia" | Bucharest | 041914 | Romania |
| Spitalul Clinic de Urgente pentru Copii "Sf. Maria" | Iași | 700309 | Romania |
| Spitalul de Psihiatrie Dr. Ghe. Preda | Sibiu | 550 082 | Romania |
| Centrul Medical Dr. Bacos Cosma | Timișoara | 300314 | Romania |
| SPHI Leningrad Regional Psychoneurological Dispensary | Pgt. Roshchino | Leningradskaya Oblast' | 188820 | Russia |
| Nizhmedklinika | Nizhny Novgorod | Nizhny Novgorod Oblast | 603159 | Russia |
| Perm State Medical University n. a. acad. E.A. Vagner | Perm | Permskiy KRAY | 614000 | Russia |
| State Budgetary Healthcare Institution of Stavropol region | Pyatigorsk | Stavropol Kray | 357538 | Russia |
| TSBHI City Hospital No. 5 of Barnaul | Barnaul | 656045 | Russia |
| FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia | Moscow | 117997 | Russia |
| FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia | Moscow | 125412 | Russia |
| Non-state Healthcare Institution | Moscow | 129128 | Russia |
| Perm State Medical University n. a. acad. E.A. Vagner | Perm | 614990 | Russia |
| LLC Medical Technologies | Saint Petersburg | 191025 | Russia |
| SPHI Leningrad Regional Psychoneurological Dispensary | Saint Petersburg | 191040 | Russia |
| FSBI V.M. Bekhterev National Research Medical Center | Saint Petersburg | 192019 | Russia |
| LLC Medical Technologies | Saint Petersburg | 192148 | Russia |
| SBHI of Saint Petersburg Psychoneurological Dispensary #5 | Saint Petersburg | 195112 | Russia |
| SBHI of Saint Petersburg Psychoneurological Dispensary #5 | Saint Petersburg | 195176 | Russia |
| Regional State Budgetary Institution of Ministry of Health | Smolensk | 214018 | Russia |
| RSBHI Smolensk Regional Clinical Hospital | Smolensk | 214018 | Russia |
| GBOU VPO "Smolensk State Medical University" | Smolensk | 214019 | Russia |
| MAI Children's City Clinical Hospital No 9 | Yekaterinburg | 620134 | Russia |
| Institute for Child and Youth Healthcare of Vojvodina | Novi Sad | Vojvodina | 21000 | Serbia |
| Mother and Child Healthcare Institute Dr Vukan Cupic | Belgrade | 11000 | Serbia |
| University Children's Hospital Belgrade | Belgrade | 11000 | Serbia |
| Clinical Center of Kragujevac | Kragujevac | 34000 | Serbia |
| National University Hospital | Singapore | 119074 | Singapore |
| KK Women's and Children's Hospital | Singapore | 229899 | Singapore |
| Neurologicka ambulancia MUDr. Eva Gasparova | Hlohovec | 92001 | Slovakia |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 120-752 | South Korea |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch | Kaohsiung City | 833 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Siriraj Hospital, Mahidol University, Faculty of Medicine | Bangkoknoi | Bangkok | 10700 | Thailand |
| Phramongkutklao Hospital, Neurology Unit, | Ratchathevee, Bangkok | 10400 | Thailand |
| Hacettepe University Medical Faculty | Ankara | Ankara/sihhiye | 06100 | Turkey (Türkiye) |
| Ege University Medical Faculty Department of Pediatrics Health and Diseases, | Izmir | Bornova/izmir | 35100 | Turkey (Türkiye) |
| Karadeniz Technical University Faculty of Medicine Farabi Hospital | Trabzon | Farabi | 61080 | Turkey (Türkiye) |
| Izmir Tepecik Training and Research Hospital | Izmir | Konak Turkey | 35120 | Turkey (Türkiye) |
| Behcet Uz Children Disease and Surgery Training and Research Hospital | Izmir | Konak | 35210 | Turkey (Türkiye) |
| Eskisehir Osmangazi University Medical Faculty | Eskişehir | Meselik Campus | 26480 | Turkey (Türkiye) |
| Dokuz Eylül University medical Faculty Internal Medicine Disease | Izmir | 34340 | Turkey (Türkiye) |
| Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5" | Dnipro | 49027 | Ukraine |
| Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia" | Dnipropetrovsk | 49100 | Ukraine |
| Ivano-Frankivska oblasna dytiacha klinichna likarnia | Ivano-Frankivsk | 76018 | Ukraine |
| Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii | Kharkiv | 61068 | Ukraine |
| Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasna klinichna psykhiatrychna li | Kharkiv | 61068 | Ukraine |
| Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam | Kyiv | 04209 | Ukraine |
| Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia, Lv | Lviv | 79010 | Ukraine |
| Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia" | Odesa | 65006 | Ukraine |
| Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdoroviaa" | Odesa | 65006 | Ukraine |
| KU "Odeska oblasna dytiacha klinichna likarnia" | Odesa | 65031 | Ukraine |
| Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia No2" | S. Oleksandrivka, Kominternivskyi R-n, Odeska Obl. | 67513 | Ukraine |
| Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii No2 | Uzhhorod | 88018 | Ukraine |
| Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia | Zaporizhzhia | 69068 | Ukraine |
| The Barberry National Centre for Mental Health | Birmingham | WEST Midlands | B15 2FG | United Kingdom |
| Salford Royal NHS Foundation Trust | Salford | M6 8HD | United Kingdom |
| FG001 | Placebo-Previous to Pregabalin-Current | Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| FG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety population included participants who took at least 1 dose of the study medication in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin: Previous and Current | Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age <4 years and BID when age >=4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| BG001 | Placebo-Previous to Pregabalin-Current | Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| BG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 28 days after last dose of study drug (up to 13 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. | Safety population included participants who took at least 1 dose of the study medication in the study. | Posted | Count of Participants | Participants | Baseline (Day 1) up to 13 Months |
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| Primary | Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months | Physical examination assessed: general appearance, dermatological, head and eyes, ears, nose, mouth, and throat, pulmonary, cardiovascular, abdominal, genitourinary (optional), lymphatic, musculoskeletal/extremities. Neurological examination assessed: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation, coordination and gait. Investigator judged clinically significant change from baseline in physical and neurological examination findings. | Safety population included participants who took at least 1 dose of the study medication in the study. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Count of Participants | Participants | Baseline up to 12 Months |
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| Primary | Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities | Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) >=30 millimeter of mercury (mmHg); maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) >=20 mmHg. | Safety population included participants who took at least 1 dose of the study medication in the study. | Posted | Count of Participants | Participants | Baseline up to 12 months |
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| Primary | Number of Participants With Tanner Staging Evaluation at Baseline | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). | Analysis population included who took at least 1 dose of the study medication in the study and with age 4 years to less than 17 years. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Count of Participants | Participants | Baseline (Day 1) |
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| Primary | Number of Participants With Tanner Staging Evaluation at Month 12 | Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). | Analysis population included who took at least 1 dose of the study medication in the study and with age 4 years to less than 17 years. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Count of Participants | Participants | Month 12 |
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| Primary | Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months | In this outcome measure number of participants with increase and decrease of >=7% in body weight, from baseline up to 12 months are reported. | Safety population included participants who took at least 1 dose of the study medication in the study. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to 12 Months |
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| Primary | Absolute Values for Body Height at Baseline | Safety population included participants who took at least 1 dose of the study medication in the study. Here,"Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Mean | Standard Deviation | Centimeters | Baseline |
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| Primary | Absolute Values for Body Height at Month 12 | Safety population included participants who took at least 1 dose of the study medication in the study. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Centimeters | Month 12 |
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| Primary | Number of Participants With Incidence of Laboratory Abnormalities | Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell(RBC) count: <0.8*lower limit of normal(LLN), platelet: <0.5*LLN/greater than (>)1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN/>1.5*ULN, lymphocyte, neutrophil- absolute/%:<0.8*LLN/>1.2*ULN, basophil, eosinophil, monocyte- absolute/%:>1.2*ULN; total/direct/indirect bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:> 3.0*ULN, total protein, albumin: <0.8*LLN/>1.2*ULN; thyroxine, thyroid stimulating hormone <0.8*LLN/>1.2*ULN; cholesterol, triglycerides:> >1.3*ULN; blood urea nitrogen, creatinine:>1.3*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium: <0.9*LLN or >1.1*ULN; glucose <0.6*LLN/>1.5*ULN, creatine kinase>2.0*ULN; urine (specific gravity <1.003/>1.030, pH <4.5/>8, glucose, ketones, protein: >=1, WBC, RBC:>=20, bacteria >20, hyaline casts/casts >1); prothrombin (PT), PT international ratio>1.1*ULN. | Analysis population included participants who took at least 1 dose of the study medication in the study and were evaluable for laboratory abnormalities. | Posted | Count of Participants | Participants | Baseline up to 12 Months |
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| Primary | Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters | Categories for which data is reported are: 1) maximum (max) PR interval increase from baseline (IFB) (millisecond [msec]) percent change (PctChg) >=25/50%; 2) maximum QRS complex increase from baseline (msec) PctChg>=50%; 3) maximum QTcB interval (Bazett's correction) increase from baseline (msec): change >=30 to <60; change >=60; 4) maximum QTcF interval (Fridericia's correction) increase from baseline (msec): change >=30 to <60; change >=60. 'PctChg>=25/50%': >= 25% increase from baseline when baseline ECG parameter is > 200 msec, and is >= 50% increase from baseline when baseline ECG parameter is non-missing and <=200 msec. | Safety population included participants who took at least 1 dose of the study medication in the study. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to 12 Months |
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| Primary | 28-Days Seizure Rate at Week 1 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. | Safety population included participants who took at least 1 dose of the study medication in the study. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Mean | Standard Deviation | Seizures Per 28-Days | Week 1 |
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| Primary | 28-Days Seizure Rate at Month 1 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. | Safety population included participants who took at least 1 dose of the study medication in the study. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Mean | Standard Deviation | Seizures Per 28-Days | Month 1 |
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| Primary | 28-Days Seizure Rate at Month 2 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. | Safety population included participants who took at least 1 dose of the study medication in the study. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Mean | Standard Deviation | Seizures Per 28-Days | Month 2 |
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| Primary | 28-Days Seizure Rate at Month 4 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. | Safety population included participants who took at least 1 dose of the study medication in the study. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Mean | Standard Deviation | Seizures Per 28-Days | Month 4 |
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| Primary | 28-Days Seizure Rate at Month 6 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. | Safety population included participants who took at least 1 dose of the study medication in the study. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Mean | Standard Deviation | Seizures Per 28-Days | Month 6 |
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| Primary | 28-Days Seizure Rate at Month 9 | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. | Safety population included participants who took at least 1 dose of the study medication in the study. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Mean | Standard Deviation | Seizures Per 28-Days | Month 9 |
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| Secondary | Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Number of participants with C-CASA code 4 are reported. C-SSRS responses mapping to C-CASA suicidal ideation code 4 are as follows: "Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with any methods (not plan) without intent to act", "active suicidal ideation with some intent to act, without specific plan", "active suicidal ideation with some intent to act, without specific plan". | Analysis population included participants who took at least 1 dose of the study medication in the study and with age >=6 years. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Count of Participants | Participants | Baseline (Day 1), Post-baseline on Day 1 up to 12 Months |
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| Secondary | Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) | Number of participants with C-CASA code 1 or 2 or 3 are reported. C-SSRS responses mapping to C-CASA suicidal behavior codes 1, 2, or 3 are as follows: (1) completed suicide; (2) suicide attempt (response of "Yes" on "actual attempt"); (3) preparatory acts toward imminent suicidal behavior ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"). | Analysis population included participants who took at least 1 dose of the study medication in the study and with age >=6 years. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Count of Participants | Participants | Baseline (Day 1), Post-baseline up to 12 Months |
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| Secondary | Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task | CogState brief battery consisted of 2 tasks- detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded "yes" using a response button with dominant hand. Participants had to "respond as fast and as accurately as possible." Detection task: measured simple reaction time to assess psychomotor function. Participant pressed a "YES" response key as soon as they detected an event (ie, a card turning face up presented in the center of the computer screen). A participant's RCI was calculated by dividing the change from individual baseline score by ([square root 2] times WSD), where WSD is within-subject standard deviation from Cogstate detection task normative data. Improvement in cognition when RCI <=-1.65, decline in cognition when RCI =>1.65. | Analysis population included participants who took at least 1 dose of the study medication in the study and were evaluable for cognitive testing. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Month 12 |
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| Secondary | Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task | CogState brief battery consisted of 2 tasks-detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded "yes" using a response button with dominant hand. Participants had to "respond as fast and as accurately as possible." Pediatric identification task: measured choice reaction time to assess visual attention. An event (a card turning face up) occurred in center of computer screen and participant decided if event met a predefined and unchanging criterion (is the color of the card black?); answered "YES" if criterion was met. A participant's RCI was calculated by dividing the change from individual baseline score by ([square root 2] times WSD),WSD=within-subject standard deviation from Cogstate task normative data. Improvement in cognition: RCI <=-1.65, decline in cognition: RCI =>1.65. | Analysis population included participants who took at least 1 dose of the study medication in the study and were evaluable for cognitive testing. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Month 12 |
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| Primary | 28-Days Seizure Rate at Month 12/Early Termination | 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. | Safety population included participants who took at least 1 dose of the study medication in the study. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Mean | Standard Deviation | Seizures Per 28-Days | Month 12/Early Termination |
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Baseline up to 13 Months
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population was evaluated.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin: Previous and Current | Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received pregabalin in previous studies. Pregabalin was administered TID when age <4 years and BID when age >=4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. | 3 | 384 | 53 | 384 | 186 | 384 |
| EG001 | Placebo-Previous to Pregabalin-Current | Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. | 4 | 210 | 23 | 210 | 103 | 210 |
| EG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. | 0 | 11 | 1 | 11 | 10 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deficiency anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Cyanosis | Cardiac disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Gingival hypertrophy | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Saliva discolouration | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Dengue fever | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Giardiasis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Peritonitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Pharyngotonsillitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Respiratory tract chlamydial infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Systemic viral infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Brain herniation | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
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| Epiphyseal injury | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
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| Unintentional medical device removal | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Periostitis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Brain oedema | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Partial seizures | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Postictal state | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Status epilepticus | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Device dislocation | Product Issues | MedDRA 22.0 | Non-systematic Assessment |
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| Device occlusion | Product Issues | MedDRA 22.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Emotional disorder | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Physical abuse | Social circumstances | MedDRA 22.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Lyme disease | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Platelet count abnormal | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Red blood cell count abnormal | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| White blood cell count abnormal | Investigations | MedDRA 22.0 | Non-systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Dysdiadochokinesis | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Resting tremor | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Behaviour disorder | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Staring | Psychiatric disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
1 death occurred in reporting arm "Placebo-Previous to Pregabalin-Current" after participant completed the study and is captured in All-cause mortality section.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 3, 2019 | Jan 31, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Participants With Treatment Related AEs |
|
| Participants With Treatment Related SAEs |
|
| OG001 |
| Placebo-Previous to Pregabalin-Current |
Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG001 | Placebo-Previous to Pregabalin-Current | Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG001 | Placebo-Previous to Pregabalin-Current | Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG001 |
| Placebo-Previous to Pregabalin-Current |
Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG001 |
| Placebo-Previous to Pregabalin-Current |
Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG001 |
| Placebo-Previous to Pregabalin-Current |
Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG001 |
| Placebo-Previous to Pregabalin-Current |
Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG001 |
| Placebo-Previous to Pregabalin-Current |
Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG001 |
| Placebo-Previous to Pregabalin-Current |
Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG001 |
| Placebo-Previous to Pregabalin-Current |
Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| Placebo-Previous to Pregabalin-Current |
Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG001 | Placebo-Previous to Pregabalin-Current | Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG001 | Placebo-Previous to Pregabalin-Current | Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| OG001 | Placebo-Previous to Pregabalin-Current | Pediatric and adult participants with POS and PGTC seizures included in this arm are those who received placebo in previous studies. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Adult participants received pregabalin 150 mg/day as liquid oral solution/capsule up to maximum of 600 mg/day. Maximum duration for treatment was 12 months. |
| OG002 | Direct Pregabalin | Only pediatric participants with POS were enrolled in this arm who did not participate in any study previously. Pregabalin was administered TID when age <4 years and BID when age >= 4 years. Pediatric participants with body weight >=30 kg received pregabalin 2.5 mg/kg/day as liquid oral solution/capsule up to maximum of 10.0 mg/kg/day and with body weight <30 kg received pregabalin 3.5 mg/kg/day as liquid oral solution up to maximum of 14.0 mg/kg/day. Maximum duration for treatment was 12 months. |
|
|
| Stage 2 |
|
| Stage 3 |
|
| Stage 4 |
|
| Stage 5 |
|
| Not Done |
|
| Missing |
|
| Stage 2 |
|
| Stage 3 |
|
| Stage 4 |
|
| Stage 5 |
|
| Not Done |
|
| Missing |
|
| Stage 2 |
|
| Stage 3 |
|
| Stage 4 |
|
| Stage 5 |
|
| Not Done |
|
| Missing |
|
| Stage 2 |
|
| Stage 3 |
|
| Stage 4 |
|
| Stage 5 |
|
| Not Done |
|
| Missing |
|