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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003420-37 | EudraCT Number |
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This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Drug Level 1 | Experimental |
| |
| Study Drug Level 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin Dose Level 1 | Drug | Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase |
| Measure | Description | Time Frame |
|---|---|---|
| Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1). | Day 1 up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | Responder Rate was defined as percentage of participants who had a 50% or greater reduction from baseline in 24-hour seizure rate during the double-blind treatment phase. Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment. |
| 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 AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) 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 |
|---|---|---|---|---|---|---|
| Pediatric Epilepsy Center of Central Florida | Orlando | Florida | 32819 | United States | ||
| Pediatric Neurology, PA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32189338 | Derived | Mann D, Antinew J, Knapp L, Almas M, Liu J, Scavone J, Yang R, Modequillo M, Makedonska I, Ortiz M, Kyrychenko A, Nordli D, Farkas V, Farkas MK; A0081042 study group. Pregabalin adjunctive therapy for focal onset seizures in children 1 month to <4 years of age: A double-blind, placebo-controlled, video-electroencephalographic trial. Epilepsia. 2020 Apr;61(4):617-626. doi: 10.1111/epi.16466. Epub 2020 Mar 18. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants received treatment in double-blind treatment phase (total duration: 21 days) which included dose escalation (5 days), fixed-dose (9 days) and taper (7 days).
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | Participants aged greater than (>) 3 months to less than (<) 4 years, received Pregabalin 3.5 milligrams per kilogram per day (mg/kg/day) (3.0 mg/kg/day for participants 1 to 3 months of age), orally three times daily (TID) in equally divided doses for first 5 days; followed by 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 7 days. |
| 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2018 | Sep 10, 2018 |
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| Pregabalin Dose Level 2 | Drug | Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase |
|
| Placebo | Drug | Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase |
|
| Day 1 up to Day 14 |
| Day 1 up to End of study (EOS) (maximum Day 25) |
| Number of Participants With Treatment-Related Treatment-Emergent 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 AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) 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 EOS (maximum Day 25) |
| 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 EOS (maximum Day 25) |
| Number of Participants With Laboratory Test Abnormalities | Abnormality Criteria: hemoglobin,hematocrit,red blood cells(RBC)count:<0.8*lower limit of normal[LLN],platelets:<0.5*LLN/>1.75*upper limit of normal[ULN]; leukocytes:<0.6*LLN/>1.5*ULN; lymphocytes,neutrophils, total protein,albumin, tetraiodothyronine,thyroid stimulating hormone:<0.8*LLN/>1.2*ULN; basophils,eosinophils,monocytes:>1.2*ULN; prothrombin [PT],PT international ratio:>1.1*ULN; aspartate aminotransferase,alanine aminotransferase,alkaline phosphatase,gamma glutamyl transferase:>0.3*ULN; bilirubin:>1.5*ULN; blood urea nitrogen,creatinine, cholesterol,triglycerides:>1.3*ULN; sodium: <0.95*LLN/>1.05*ULN; potassium,chloride,calcium,bicarbonate:<0.9*LLN/>1.1*ULN; glucose fasting:<0.6*LLN/>1.5*ULN; creatine kinase:>2*ULN;urine glucose,ketone,protein:>=1;urine WBC,RBC:>= 20/High Power Field[HPF]; urine casts,hyaline casts:>1/Low Power Field; urine bacteria:>20/HPF. | From Baseline up to EOS (maximum Day 25) |
| Number of Participants With Vital Signs Abnormalities | Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: maximum increase and decrease of greater than or equal to (>=) 30 millimeter of mercury (mmHg) from baseline; sitting/supine diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline. | From Baseline (BL) up to EOS (maximum Day 25) |
| Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Physical examinations evaluated the following body systems/organs: abdomen; ears; extremities; eyes; general appearance; head; heart; lungs; lymph nodes; mouth; musculoskeletal; nose; skin and throat. Abnormalities in physical examination were based on investigator's discretion. | Screening and EOS (maximum Day 25) |
| Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Neurological examinations included: coordination; cranial nerve function (CNF); gait and station; level of consciousness (LOC); lower and upper extremity sensation; muscle strength; muscle tone; nystagmus; reflexes and speech. Abnormalities in neurological examination were based on investigator's discretion and also, some components of the neurological examination were not done for certain participants due to participant age or significant developmental impairment. Only those categories of neurological examination in which at least 10% of participants had an abnormality in any treatment group at any time point were reported in this outcome measure. | Baseline (BL) and EOS (maximum Day 25) |
| 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 (maximum QTCB interval 450-<480 msec), were reported in this outcome measure. | From screening up to EOS (maximum Day 25) |
| Orlando |
| Florida |
| 32819 |
| United States |
| Pediatric Epilepsy & Neurology Specialists, PA | Tampa | Florida | 33609 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Road Runner Research, Ltd. | San Antonio | Texas | 78249 | United States |
| GU Republican Scientific and Practical Center Mother and Child | Minsk | 220053 | Belarus |
| UZ Brussel | Brussels | Brussels Capital | 1090 | Belgium |
| University Clinical Centre of the Republic of Srpska | Banja Luka | 78000 | Bosnia and Herzegovina |
| UMHAT Dr. Georgi Stranski Ltd. | Pleven | 5800 | Bulgaria |
| UMHAT "Sveti Georgi" Ltd. | Plovdiv | 4002 | Bulgaria |
| The First Bethune Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
| Beijing Children's Hospital | Beijing | 100045 | China |
| Hopital Raymond Poincare | Garches | 92380 | France |
| Universitaetsklinikum Jena | Jena | Thuringia | 07747 | Germany |
| University General Hospital Attikon | Athens | 12462 | Greece |
| General Hospital of Thessaloniki Ippokratio | Thessaloniki | 54642 | Greece |
| Dr. Kenessey Albert Korhaz es Rendelointezet | Balassagyarmat | H-2660 | Hungary |
| Szent János Kórház es Észak Budai Egyesitett Kórházak | Budapest | H-1023 | Hungary |
| Szent Margit Kórház | Budapest | H-1032 | Hungary |
| Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika | Budapest | H-1083 | Hungary |
| Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia | Budapest | H-1146 | Hungary |
| Debreceni Egyetem Klinikai Központ | Debrecen | H-4032 | Hungary |
| Pharmacy of The E. Wolfson Medical Center | Holon | 5810001 | Israel |
| The E. Wolfson Medical Center | Holon | 5810001 | Israel |
| Pharmacy of Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
| 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 |
| Cebu Doctors' University Hospital | Cebu City | CEBU | 6000 | Philippines |
| Perpetual Succour Hospital | Cebu City | CEBU | 6000 | Philippines |
| Manila Doctors Hospital | Manila | 1000 | Philippines |
| Metropolitan Medical Center | Manila | 1003 | 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 |
| Centrul Medical Unirea | Bucharest | 013766 | Romania |
| Spitalul Clinic de Urgente pentru Copii "Sf. Maria" | Iași | 700309 | Romania |
| Nizhmedklinika | Nizhny Novgorod | Nizhny Novgorod Oblast | 603159 | Russia |
| Perm State Medical University n. a. acad. E.A. Vagner | Perm | Permskiy KRAY | 614000 | 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 |
| Perm State Medical University n. a. acad. E.A. Vagner | Perm | 614990 | Russia |
| LLC Medical Technologies | Saint Petersburg | 191025 | Russia |
| LLC Medical Technologies | Saint Petersburg | 192148 | Russia |
| St. Petersburg State Pediatric Medical University | Saint Petersburg | 194100 | Russia |
| "Baltiyskaya Medicyna" LLC | Saint Petersburg | 194356 | Russia |
| RSBHI Smolensk Regional Clinical Hospital | Smolensk | 214018 | Russia |
| SHI Ulyanovsk Regional Children's Clinical Hospital n. a. Y.F.Goryachev | Ulyanovsk | 432011 | Russia |
| SHI Central Clinical Medical Unit | Ulyanovsk | 432026 | Russia |
| SHI Central Clinical Medical Unit | Ulyanovsk | 432045 | Russia |
| MAI Children's City Clinical Hospital 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 |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Chang Gung Memorial Hospital- Kaohsiung branch | Kaohsiung City | 833 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Siriraj Hospital, Faculty of Medicine, Mahidol University | Bangkoknoi | Bangkok | 10700 | Thailand |
| Phramongkutklao Hospital | Ratchathevee | Bangkok | 10400 | Thailand |
| Izmir Tepecik Training and Research Hospital | Izmir | Konak | 35120 | Turkey (Türkiye) |
| Eskisehir Osmangazi Universitesi Tip Fakultesi | Eskişehir | 26480 | Turkey (Türkiye) |
| Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi | Trabzon | 61080 | Turkey (Türkiye) |
| Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5" | Dnipro | 49027 | Ukraine |
| Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia" | Dnipro | 49100 | Ukraine |
| Ivano-Frankivska oblasna dytiacha klinichna likarnia | Ivano-Frankivsk | 76018 | Ukraine |
| DZ "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam | Kyiv | 04209 | Ukraine |
| Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,viddilennia neirokhirurhii #2 | Uzhhorod | 88018 | Ukraine |
| FG001 | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Participants aged >3 months to <4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 2 days and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days; followed by 14 mg/kg/day (12 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days; and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 4 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days. |
| FG002 | Placebo | Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days. |
| COMPLETED |
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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 7 mg/kg/Day or 6 mg/kg/Day | Participants aged > 3 months to < 4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 5 days; followed by 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 7 days. |
| BG001 | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Participants aged >3 months to <4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 2 days and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days; followed by 14 mg/kg/day (12 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days; and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 4 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days. |
| BG002 | Placebo | Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days. |
| 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 | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kilogram |
|
| 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 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1). | Modified intent-to-treat (mITT) population included all randomized participants who took at least one dose of study drug during the double-blind treatment phase, had a baseline with at least one partial onset seizure identified by video-EEG (at least 24 hours of evaluable monitoring) and a treatment phase video-EEG. | Posted | Least Squares Mean | Standard Error | seizures per 24 hours | Day 1 up to Day 14 |
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| Secondary | Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase | Responder Rate was defined as percentage of participants who had a 50% or greater reduction from baseline in 24-hour seizure rate during the double-blind treatment phase. Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment. | mITT population included all randomized participants who took at least one dose of study drug during the double-blind treatment phase, had a baseline with at least one partial onset seizure identified by Video-EEG (at least 24 hours of evaluable monitoring) and a treatment phase Video-EEG. | Posted | Number | percentage of participants | Day 1 up to Day 14 |
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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 AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) 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 received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to End of study (EOS) (maximum Day 25) |
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| Other Pre-specified | Number of Participants With Treatment-Related Treatment-Emergent 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 AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) 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 received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Day 1 up to EOS (maximum Day 25) |
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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 received at least 1 dose of study drug. | Posted | Number | events | Day 1 up to EOS (maximum Day 25) |
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| Other Pre-specified | Number of Participants With Laboratory Test Abnormalities | Abnormality Criteria: hemoglobin,hematocrit,red blood cells(RBC)count:<0.8*lower limit of normal[LLN],platelets:<0.5*LLN/>1.75*upper limit of normal[ULN]; leukocytes:<0.6*LLN/>1.5*ULN; lymphocytes,neutrophils, total protein,albumin, tetraiodothyronine,thyroid stimulating hormone:<0.8*LLN/>1.2*ULN; basophils,eosinophils,monocytes:>1.2*ULN; prothrombin [PT],PT international ratio:>1.1*ULN; aspartate aminotransferase,alanine aminotransferase,alkaline phosphatase,gamma glutamyl transferase:>0.3*ULN; bilirubin:>1.5*ULN; blood urea nitrogen,creatinine, cholesterol,triglycerides:>1.3*ULN; sodium: <0.95*LLN/>1.05*ULN; potassium,chloride,calcium,bicarbonate:<0.9*LLN/>1.1*ULN; glucose fasting:<0.6*LLN/>1.5*ULN; creatine kinase:>2*ULN;urine glucose,ketone,protein:>=1;urine WBC,RBC:>= 20/High Power Field[HPF]; urine casts,hyaline casts:>1/Low Power Field; urine bacteria:>20/HPF. | Safety population included all randomized participants who received at least 1 dose of study drug. Here, "Overall number of participants analyzed"= number of participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From Baseline up to EOS (maximum Day 25) |
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| Other Pre-specified | Number of Participants With Vital Signs Abnormalities | Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: maximum increase and decrease of greater than or equal to (>=) 30 millimeter of mercury (mmHg) from baseline; sitting/supine diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline. | Safety population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From Baseline (BL) up to EOS (maximum Day 25) |
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| Other Pre-specified | Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study | Physical examinations evaluated the following body systems/organs: abdomen; ears; extremities; eyes; general appearance; head; heart; lungs; lymph nodes; mouth; musculoskeletal; nose; skin and throat. Abnormalities in physical examination were based on investigator's discretion. | Safety population included all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies number of participants who were evaluable for the specified category for each arm respectively. | Posted | Number | percentage of participants | Screening and EOS (maximum Day 25) |
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| Other Pre-specified | Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study | Neurological examinations included: coordination; cranial nerve function (CNF); gait and station; level of consciousness (LOC); lower and upper extremity sensation; muscle strength; muscle tone; nystagmus; reflexes and speech. Abnormalities in neurological examination were based on investigator's discretion and also, some components of the neurological examination were not done for certain participants due to participant age or significant developmental impairment. Only those categories of neurological examination in which at least 10% of participants had an abnormality in any treatment group at any time point were reported in this outcome measure. | Safety population included all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies number of participants who were evaluable for the specified category for each arm respectively. | Posted | Number | percentage of participants | Baseline (BL) and EOS (maximum Day 25) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 (maximum QTCB interval 450-<480 msec), were reported in this outcome measure. | Safety population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From screening up to EOS (maximum Day 25) |
|
Day 1 up to End of Study (maximum Day 25)
Not provided
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 7 mg/kg/Day or 6 mg/kg/Day | Participants aged > 3 months to < 4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 5 days; followed by 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 7 days. | 0 | 71 | 0 | 71 | 32 | 71 |
| EG001 | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Participants aged >3 months to <4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 2 days and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days; followed by 14 mg/kg/day (12 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days; and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 4 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days. | 0 | 34 | 1 | 34 | 16 | 34 |
| EG002 | Placebo | Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days. | 0 | 70 | 4 | 70 | 37 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA (v20.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Bradyarrhythmia | Cardiac disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Mydriasis | Eye disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Oral contusion | Gastrointestinal disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Regurgitation | Gastrointestinal disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Application site irritation | General disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Sluggishness | General disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Lice infestation | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Electrocardiogram repolarisation abnormality | Investigations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Lymphocyte morphology abnormal | Investigations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Lymphocyte percentage increased | Investigations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Neutrophil percentage decreased | Investigations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Myoclonic epilepsy | Nervous system disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Enuresis | Psychiatric disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Vesicoureteric reflux | Renal and urinary disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (v20.1) | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (v20.1) | 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 |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 15, 2017 | Sep 10, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| Male |
|
| White |
|
| Other |
|
Linear model with log transformed baseline seizure rate as continuous covariate and treatment, age stratum, and geographical region as fixed factor effects.
| ANCOVA |
| 0.0223 |
| Least Square Mean Difference |
| -0.43 |
| Standard Error of the Mean |
| 0.185 |
| 2-Sided |
| 95 |
| -0.80 |
| -0.06 |
| Superiority |
Participants aged >3 months to <4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 2 days and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days; followed by 14 mg/kg/day (12 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days; and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 4 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days. |
| OG002 | Placebo | Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days. |
|
|
|
Participants aged >3 months to <4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 2 days and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days; followed by 14 mg/kg/day (12 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days; and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 4 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days. |
| OG002 | Placebo | Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days. |
|
|
Participants aged >3 months to <4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 2 days and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days; followed by 14 mg/kg/day (12 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days; and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 4 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days. |
| OG002 | Placebo | Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days. |
|
|
| OG002 | Placebo | Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days. |
|
|
| OG001 | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Participants aged >3 months to <4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 2 days and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days; followed by 14 mg/kg/day (12 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days; and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 4 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days. |
| OG002 | Placebo | Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days. |
|
|
| OG002 | Placebo | Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days. |
|
|
| OG002 | Placebo | Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days. |
|
|
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day |
Participants aged >3 months to <4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 2 days and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days; followed by 14 mg/kg/day (12 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days; and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 4 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days. |
| OG002 | Placebo | Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days. |
|
|
| OG001 | Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | Participants aged >3 months to <4 years, received Pregabalin 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for first 2 days and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days; followed by 14 mg/kg/day (12 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for 9 days; and 7 mg/kg/day (6 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 4 days and 3.5 mg/kg/day (3.0 mg/kg/day for participants 1 to 3 months of age), orally TID in equally divided doses for next 3 days. |
| OG002 | Placebo | Participants aged >3 months to <4 years received placebo matched to Pregabalin, orally TID for 21 days. |
|
|