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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020852-79 | EudraCT Number | ||
| XALCORY 1014 | Other Identifier | Alias Study Number |
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Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Pregabalin Level 1 (max 150 mg/day) | Experimental |
| |
| Pregabalin Level 2 (max 600 mg day) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin add-on therapy | Drug | Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period. |
| Measure | Description | Time Frame |
|---|---|---|
| Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase | All partial onset seizures experienced during baseline phase were recorded by the participants or their parents/legal guardian, in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the baseline phase] divided by [number of days in baseline phase minus {-} number of missing diary days in baseline phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1). | Baseline phase (up to 8 weeks prior to treatment phase [Day 1]) |
| Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase | All partial onset seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {-} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1). | Day 1 up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase | Percentage of participants with 50 percent (%) or greater reduction from baseline in 28-day seizure rate during the 12 week treatment phase were reported. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {-} number of missing diary days in treatment phase])*28. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (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 were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre- treatment state. AEs included both serious and non-serious adverse events. |
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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30688135 | Derived | Antinew J, Pitrosky B, Knapp L, Almas M, Pitman V, Liu J, Craiu D, Modequillo M, Nordli D, Farkas V, Farkas MK. Pregabalin as Adjunctive Treatment for Focal Onset Seizures in Pediatric Patients: A Randomized Controlled Trial. J Child Neurol. 2019 Apr;34(5):248-255. doi: 10.1177/0883073818821035. Epub 2019 Jan 27. |
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | Participants aged 4 to 16 years and less than (<) 30 kilograms (kg) in weight, received pregabalin 3.5 milligram per kilogram per day (mg/kg/day) (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and greater than or equal to (>=) 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Pregabalin add-on therapy | Drug | Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period. |
|
| Pregabalin add-on therapy | Drug | Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period. |
|
| Day 1 up to Week 12 |
| Day 1 up to 7 days after last dose of study drug (up to 13 weeks) |
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events. | Day 1 up to 7 days after last dose of study drug (up to 13 weeks) |
| Number of Adverse Events by Severity | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant's usual function b) moderate: AEs interferes to some extent with participant's usual function c) severe: AEs interferes significantly with participant's usual function. | Day 1 up to 7 days after last dose of study drug (up to 13 weeks) |
| Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories At Baseline | The C-SSRS (mapped to C-CASA) is a participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of "Yes" on "actual attempt") (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) ("Yes" on "preparatory acts or behavior")(C-CASA code 3); suicidal ideation ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). In this outcome, number of participants with positive response (response of "yes") to C-SSRS (mapped to C-CASA categories 2, 3, 4 and 7) at baseline were reported. | Baseline (4 week prior to Day 1 of treatment) |
| Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories During Post Baseline Time Period | C-SSRS (mapped to C-CASA):participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of "Yes" on "actual attempt") (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) ("Yes" on "preparatory acts or behavior")(C-CASA code 3); suicidal ideation ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). Number of participants with positive response (response of "yes") to C-SSRS (mapped to C-CASA categories 1, 2, 3, 4 and 7) during post baseline time period (Day 1 up to Week 13) were reported | Day 1 up to Week 13 |
| Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age | CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study. | Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13) |
| Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age | CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study | Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13) |
| Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age | CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study | Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13) |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Scores at Week 12: Detection Task | CogState battery:computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. In this study, Cogstate battery consisted of 2 tasks which measured psychomotor function (detection task) and attention (paediatric identification task). Detection task was a measure of simple reaction time and provided a valid assessment of psychomotor function in participants. In this task, a playing card turning face up was presented in the center of the computer screen. As soon as this happened, the participant was to press the 'Yes' response key. There was no minimum or maximum scores since it was a time-based assessment. The software measured the speed of accurate responses to each event. In this outcome measure, speed of performance of participants (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance. | Baseline (pre-dose at Day 1), Week 12 |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Week 12: Paediatric Identification (Go-No Go: Attention) Tasks | CogState battery: computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. Paediatric identification task: a measure of choice reaction time and valid assessment of visual attention. In this task, a playing card turning face up was presented in center of the computer screen. As soon as this happened, participant had to decide whether color of card was black or not. If color was black, participants was to press "Yes" response key, otherwise "no". There was no minimum/maximum scores since it was a time-based assessment. The software measured speed of accurate responses (correct identification of color) to each event. In this outcome measure, speed of performance of participants to correctly identify the color (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance. | Baseline (pre-dose at Day 1), Week 12 |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Criteria for abnormality: hematology (hemoglobin, hematocrit, red blood cells count:<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],leukocytes:<0.6*LLN or>1.5*ULN, lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes:>1.2*ULN); Liver Function(aspartate aminotransferase ,alanine aminotransferase, alkaline phosphatase, Gamma glutamyl transferase:>0.3*ULN, total protein, albumin:<0.8*LLN or >1.2*ULN); bilirubin:>1.5*ULN; renal function(blood urea nitrogen, creatinine:>1.3*ULN); Electrolytes(sodium:<0.95*LLN or>1.05*ULN, potassium, chloride, calcium, bicarbonate:<0.9*LLN or >1.1*ULN); Lipids(cholesterol, triglycerides >1.3*ULN); creatine kinase:>2.0*ULN; glucose fasting:<0.6*LLN or >1.5*ULN, urine white blood corpuscles and RBC:>= 20/High Power Field [HPF];urine casts: >1/Low Power Field(LPF);urine bacteria:>20/HPF. Hormones (tetraiodothyronine and thyroid stimulating hormone:<0.8*LLN or >1.2*ULN). | Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13 |
| Number of Participants With Vital Signs Abnormalities | Criteria for abnormalities in vital signs included: sitting systolic blood pressure (SBP) values: maximum increase and decrease of >=30 millimeter of mercury (mmHg) from baseline; sitting diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline. | Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13 |
| Number of Participants With Clinically Significant Change From Baseline in Neurological Examinations | Neurological examinations included: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation (the latter using a 128-Hertz tuning fork), coordination and gait. Clinical significance was based on investigator's discretion. | Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13 |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): >=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTCF interval): absolute value 450 to <480 msec, 480 to <500 msec, >=500 msec; 4) Maximum QT interval: >=500 msec; 5) Maximum QTCB interval (Bazett's correction): 450 to< 480 msec, 480 to <500 msec, >=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal, were reported in this outcome measure. | Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13 |
| Number of Participants With Clinically Significant Change From Baseline in Physical Examinations at Week 13 | Physical examinations evaluated the following body systems/organs: general appearance; dermatological; head and eyes; ears, nose, mouth, and throat; pulmonary; cardiovascular; abdominal; genitourinary (optional); lymphatic; musculoskeletal/extremities; and neurological. Clinical significance was determined by the investigator. | Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13 |
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | 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 Neurology, P.A. | Orlando | Florida | 32819 | United States |
| Tallahassee Neurological Clinic | Tallahassee | Florida | 32308 | United States |
| Center for Clinical and Translational Science | Lexington | Kentucky | 40536 | United States |
| Kentucky Neuroscience Institute | Lexington | Kentucky | 40536 | United States |
| University of Kentucky Hospital Epilepsy Monitoring Unit | Lexington | Kentucky | 40536 | United States |
| University of Kentucky Hospital Pharmacy, UK Chandler Hosptial | Lexington | Kentucky | 40536 | United States |
| Kosair Charities Pediatric Clinical | Louisville | Kentucky | 40202 | 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 |
| Duke Children's Hospital and Health Center | Durham | North Carolina | 27710 | United States |
| Duke Clinical Research Unit | Durham | North Carolina | 27710 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| Road Runner Research, Ltd. | San Antonio | Texas | 78258 | United States |
| Centre Hospitalier Neurologique William Lennox | Ottignies | Brabant Wallon | 1340 | Belgium |
| HUDERF | Brussels | Brussels Capital | 1020 | Belgium |
| Cliniques Universitaires de Bruxelles Hôpital Erasme | Brussels | 1070 | Belgium |
| UMBAL Sveti Georgi, Klinika po pediatria i genetichni zabolyavania | Plovdiv | 4000 | Bulgaria |
| Fakultni nemocnice Brno - Detska nemocnice | Brno - Cerna Pole | 613 00 | Czechia |
| Fakultni nemocnice v Motole | Prague | 150 06 | Czechia |
| CHU Bordeaux - Hopital des Enfants | Bordeaux | 33076 | France |
| Hôpital Mère Enfant | Bron | 69677 | France |
| Hopital Raymond Poincare | Garches | 92380 | France |
| Hopitaux Universitaires de Strasbourg - Hopital Hautepierre | Strasbourg | 67098 | France |
| General Childrens Hospital of Athens P & A Kyriakou | Athens | 11527 | Greece |
| General Children's Hospital Penteli | Athens | 15236 | Greece |
| Dr. Kenessey Albert Korhaz es Rendelointezet | Balassagyarmat | H-2660 | Hungary |
| Szent Janos Korhaz es Eszak Budai Egyesitett Korhazak | Budapest | H-1023 | Hungary |
| Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika | Budapest | H-1083 | Hungary |
| Heim Pal Gyermekkorhaz, Neurologiai Osztaly | Budapest | H-1089 | Hungary |
| Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia | Budapest | H-1146 | Hungary |
| Pécsi Tudományegyetem Klinikai Központ | Pécs | 7623 | Hungary |
| Bnai Zion Medical Center | Haifa | 3104802 | Israel |
| 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 - Servizio di Farmacia | Pavia | 27100 | Italy |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS | Pavia | 27100 | Italy |
| Paediatric Department | Ipoh | Perak | 30990 | Malaysia |
| Hospital Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Cebu Doctors' University Hospital | Cebu City | CEBU | 6000 | Philippines |
| Center for Neurodiagnostic and Therapeutic Services | Sta Cruz | Manila | 1003 | Philippines |
| Capitol Medical Center Inc. | Quezon City | National Capital Region | 1100 | Philippines |
| Cebu Doctors' University Hospital | Cebu City | 6000 | Philippines |
| University of Santo Tomas Hospital | Manila | 1008 | Philippines |
| St. Luke's Medical Center | Quezon City | 1102 | Philippines |
| Philippine Children's Medical Center | Quezon City | 1105 | Philippines |
| Klinika Neurologii Rozwojowej | Gdansk | 80-952 | Poland |
| NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki | Kielce | 25316 | Poland |
| Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie | Krakow | 31-503 | Poland |
| Katedra i Klinika Neurologii Wieku Rozwojowego | Poznan | 60-355 | Poland |
| Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka | Wroclaw | 54-049 | Poland |
| Spitalul clinic de copii Dr. Victor Gomoiu | Bucharest | 022102 | 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 |
| 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 |
| Samsung Medical Center/ Department of Pediatrics, Pediatric Neurology | Seoul | 06351 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 120 752 | South Korea |
| Ege University Medical Faculty Department of Pediatrics Health and Diseases | Izmir | Bornova | 35100 | Turkey (Türkiye) |
| Karadeniz Technical University Faculty of Medicine Farabi Hospital | Trabzon | Farabi | 61080 | Turkey (Türkiye) |
| Izmir Tepecik Training and Research Hospital | Izmir | Konak | 35120 | Turkey (Türkiye) |
| Behcet Uz Children Disease and surgery Training and research hospital | Izmir | Konak | 35210 | Turkey (Türkiye) |
| Marmara University Pendik Training and Research Hospital | Istanbul | Pendik | 34890 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty | Ankara | Sihhiye/ankara | 06100 | Turkey (Türkiye) |
| Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia | Dnipropetrovsk | 49027 | Ukraine |
| Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia" | Dnipropetrovsk | 49100 | Ukraine |
| Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii | Kharkiv | 61068 | Ukraine |
| Derzhavna Ustanova Instytut Nevrolohii, Psykhiatrii ta Narkolohii NAMN Ukrainy, | Kharkiv | 61068 | Ukraine |
| Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z | Kyiv | 04209 | Ukraine |
| Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia", | Odesa | 65006 | Ukraine |
| Komunalna ustanova "Odeska oblasna dytiacha klinichna likarnia", Oblasnyi tsentr rannoi | Odesa | 65031 | Ukraine |
| Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2", | S. Oleksandrivka | 67513 | Ukraine |
| Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii 2, | Uzhhorod | 88018 | Ukraine |
| FG001 | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| FG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
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| NOT COMPLETED |
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Safety population included all randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| BG001 | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| BG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase | All partial onset seizures experienced during baseline phase were recorded by the participants or their parents/legal guardian, in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the baseline phase] divided by [number of days in baseline phase minus {-} number of missing diary days in baseline phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1). | Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment. | Posted | Mean | Standard Deviation | Seizures per 28 days | Baseline phase (up to 8 weeks prior to treatment phase [Day 1]) |
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| Primary | Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase | All partial onset seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {-} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1). | ITT population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment. Here, "Number of Participants Analyzed (N)" signifies number of participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Seizures per 28 days | Day 1 up to Week 12 |
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| Secondary | Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase | Percentage of participants with 50 percent (%) or greater reduction from baseline in 28-day seizure rate during the 12 week treatment phase were reported. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {-} number of missing diary days in treatment phase])*28. | ITT population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment. | Posted | Number | percentage of participants | Day 1 up to Week 12 |
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| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (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 were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre- treatment state. AEs included both serious and non-serious adverse events. | Safety population included all randomized participants who took at least 1 dose of the study drug. | Posted | Number | participants | Day 1 up to 7 days after last dose of study drug (up to 13 weeks) |
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| Other Pre-specified | Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events. | Safety population included all randomized participants who took at least 1 dose of the study drug. | Posted | Number | participants | Day 1 up to 7 days after last dose of study drug (up to 13 weeks) |
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| Other Pre-specified | Number of Adverse Events by Severity | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant's usual function b) moderate: AEs interferes to some extent with participant's usual function c) severe: AEs interferes significantly with participant's usual function. | Safety population included all randomized participants who took at least 1 dose of the study drug. | Posted | Number | events | Day 1 up to 7 days after last dose of study drug (up to 13 weeks) |
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| Other Pre-specified | Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories At Baseline | The C-SSRS (mapped to C-CASA) is a participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of "Yes" on "actual attempt") (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) ("Yes" on "preparatory acts or behavior")(C-CASA code 3); suicidal ideation ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). In this outcome, number of participants with positive response (response of "yes") to C-SSRS (mapped to C-CASA categories 2, 3, 4 and 7) at baseline were reported. | Safety population included all randomized participants who took at least 1 dose of the study drug. Here, "N" signifies number of participants who were evaluable for this outcome measure. | Posted | Number | participants | Baseline (4 week prior to Day 1 of treatment) |
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| Other Pre-specified | Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories During Post Baseline Time Period | C-SSRS (mapped to C-CASA):participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of "Yes" on "actual attempt") (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) ("Yes" on "preparatory acts or behavior")(C-CASA code 3); suicidal ideation ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). Number of participants with positive response (response of "yes") to C-SSRS (mapped to C-CASA categories 1, 2, 3, 4 and 7) during post baseline time period (Day 1 up to Week 13) were reported | Safety population included all randomized participants who took at least 1 dose of the study drug. Here, "N" signifies number of participants who were evaluable for this outcome measure. | Posted | Number | participants | Day 1 up to Week 13 |
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| Other Pre-specified | Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age | CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study. | Safety population included all randomized participants who took at least 1 dose of the study drug.Here, "N" signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively. | Posted | Mean | Standard Deviation | T scores | Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13) |
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| Other Pre-specified | Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age | CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study | Safety population included all randomized participants who took at least 1 dose of the study drug.Here, "N" signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively. | Posted | Mean | Standard Deviation | T scores | Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13) |
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| Other Pre-specified | Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age | CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study | Safety population included all randomized participants who took at least 1 dose of the study drug.Here, "N" signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively. | Posted | Mean | Standard Deviation | T scores | Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13) |
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| Other Pre-specified | Change From Baseline in Cognitive Test Battery (CogState Battery) Scores at Week 12: Detection Task | CogState battery:computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. In this study, Cogstate battery consisted of 2 tasks which measured psychomotor function (detection task) and attention (paediatric identification task). Detection task was a measure of simple reaction time and provided a valid assessment of psychomotor function in participants. In this task, a playing card turning face up was presented in the center of the computer screen. As soon as this happened, the participant was to press the 'Yes' response key. There was no minimum or maximum scores since it was a time-based assessment. The software measured the speed of accurate responses to each event. In this outcome measure, speed of performance of participants (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance. | Safety population included all randomized participants who took at least 1 dose of the study drug.Here, "N" signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively. | Posted | Mean | Standard Deviation | log10 milliseconds | Baseline (pre-dose at Day 1), Week 12 |
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| Other Pre-specified | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Week 12: Paediatric Identification (Go-No Go: Attention) Tasks | CogState battery: computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. Paediatric identification task: a measure of choice reaction time and valid assessment of visual attention. In this task, a playing card turning face up was presented in center of the computer screen. As soon as this happened, participant had to decide whether color of card was black or not. If color was black, participants was to press "Yes" response key, otherwise "no". There was no minimum/maximum scores since it was a time-based assessment. The software measured speed of accurate responses (correct identification of color) to each event. In this outcome measure, speed of performance of participants to correctly identify the color (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance. | Safety population included all randomized participants who took at least 1 dose of the study drug.Here, "N" signifies number of participants who were evaluable for this measure and 'n' signifies number of participants evaluated for specific categories for each arm respectively. | Posted | Mean | Standard Deviation | log10 milliseconds | Baseline (pre-dose at Day 1), Week 12 |
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| Other Pre-specified | Number of Participants With Clinically Significant Laboratory Abnormalities | Criteria for abnormality: hematology (hemoglobin, hematocrit, red blood cells count:<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],leukocytes:<0.6*LLN or>1.5*ULN, lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes:>1.2*ULN); Liver Function(aspartate aminotransferase ,alanine aminotransferase, alkaline phosphatase, Gamma glutamyl transferase:>0.3*ULN, total protein, albumin:<0.8*LLN or >1.2*ULN); bilirubin:>1.5*ULN; renal function(blood urea nitrogen, creatinine:>1.3*ULN); Electrolytes(sodium:<0.95*LLN or>1.05*ULN, potassium, chloride, calcium, bicarbonate:<0.9*LLN or >1.1*ULN); Lipids(cholesterol, triglycerides >1.3*ULN); creatine kinase:>2.0*ULN; glucose fasting:<0.6*LLN or >1.5*ULN, urine white blood corpuscles and RBC:>= 20/High Power Field [HPF];urine casts: >1/Low Power Field(LPF);urine bacteria:>20/HPF. Hormones (tetraiodothyronine and thyroid stimulating hormone:<0.8*LLN or >1.2*ULN). | Safety population included all randomized participants who took at least 1 dose of the study drug. Here, "N" signifies number of participants who were evaluable for this outcome measure. | Posted | Number | participants | Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13 |
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| Other Pre-specified | Number of Participants With Vital Signs Abnormalities | Criteria for abnormalities in vital signs included: sitting systolic blood pressure (SBP) values: maximum increase and decrease of >=30 millimeter of mercury (mmHg) from baseline; sitting diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline. | Safety population included all randomized participants who took at least 1 dose of the study drug. Here, "N" signifies number of participants who were evaluable for this outcome measure. | Posted | Number | participants | Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13 |
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| Other Pre-specified | Number of Participants With Clinically Significant Change From Baseline in Neurological Examinations | Neurological examinations included: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation (the latter using a 128-Hertz tuning fork), coordination and gait. Clinical significance was based on investigator's discretion. | Safety population included all randomized participants who took at least 1 dose of the study drug. | Posted | Number | participants | Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13 |
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| Other Pre-specified | Number of Participants With Electrocardiogram (ECG) Abnormalities | Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): >=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTCF interval): absolute value 450 to <480 msec, 480 to <500 msec, >=500 msec; 4) Maximum QT interval: >=500 msec; 5) Maximum QTCB interval (Bazett's correction): 450 to< 480 msec, 480 to <500 msec, >=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal, were reported in this outcome measure. | Safety population included all randomized participants who took at least 1 dose of the study drug. Here, "N" signifies number of participants who were evaluable for this outcome measure. | Posted | Number | participants | Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13 |
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| Other Pre-specified | Number of Participants With Clinically Significant Change From Baseline in Physical Examinations at Week 13 | Physical examinations evaluated the following body systems/organs: general appearance; dermatological; head and eyes; ears, nose, mouth, and throat; pulmonary; cardiovascular; abdominal; genitourinary (optional); lymphatic; musculoskeletal/extremities; and neurological. Clinical significance was determined by the investigator. | Safety population included all randomized participants who took at least 1 dose of the study drug. | Posted | Number | participants | Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). | 5 | 104 | 66 | 104 | ||
| EG001 | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). | 10 | 97 | 64 | 97 | ||
| EG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. | 7 | 94 | 55 | 94 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Drug withdrawal convulsions | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Skin graft | Surgical and medical procedures | MedDRA v19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
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| Lymphadenitis | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Asthenopia | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hypermetropia | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Myopia | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Visual brightness | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Tongue disorder | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Tooth erosion | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Energy increased | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Sluggishness | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Ascariasis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Conjunctivitis viral | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dermatitis infected | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Gastrointestinal candidiasis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Parasitic gastroenteritis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Ear abrasion | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Eye contusion | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Scar | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA v19.0 | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Gamma-glutamyl transferase increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hyperphagia | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Overweight | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Clonus | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Partial seizures with secondary generalisation | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Tunnel vision | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Disinhibition | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Middle insomnia | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Mutism | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Tic | Psychiatric disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Breast swelling | Reproductive system and breast disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pruritus genital | Reproductive system and breast disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hypopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
|
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 |
| 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
| Male |
|
| OG001 | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
|
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
|
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day |
Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
| OG001 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day |
Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
| OG001 | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
| OG001 | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
| OG001 | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
| OG001 | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
| OG001 | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
| OG001 | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
| OG001 | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
| OG001 | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
| OG001 | Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). |
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|
| OG002 | Placebo | Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule. |
|
|