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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02072824
Other study ID # A0081042
Secondary ID 2013-003420-37
Status Completed
Phase Phase 3
First received
Last updated
Start date September 16, 2014
Est. completion date March 13, 2018

Study information

Verified date September 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date March 13, 2018
Est. primary completion date March 13, 2018
Accepts healthy volunteers No
Gender All
Age group 1 Month to 3 Years
Eligibility Inclusion Criteria: - Subject must have 3 partial onset seizures in the month prior to screening. - Subject must have 2 partial onset seizures during the 48 hour baseline phase. - Signed Informed Consent. - On 1-3 stable anti-epileptic drugs at screening. Exclusion Criteria: - Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms. - Lennox-Gasteau, BECTS, and Dravet's syndrome. - Status epliepticus within 1 year of screening. - Any change in AED regimen with 7 days of screening. - Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy. - Progressive errors of metabolism.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pregabalin Dose Level 1
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
Pregabalin Dose Level 2
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
Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase

Locations

Country Name City State
Belarus GU Republican Scientific and Practical Center Mother and Child Minsk
Belgium UZ Brussel Brussels Bruxelles Capitale
Bosnia and Herzegovina University Clinical Centre of the Republic of Srpska Banja Luka
Bulgaria UMHAT Dr. Georgi Stranski Ltd. Pleven
Bulgaria UMHAT "Sveti Georgi" Ltd. Plovdiv
China Beijing Children's Hospital Beijing
China The First Bethune Hospital of Jilin University Changchun Jilin
China Children's Hospital of Fudan University Shanghai Shanghai
France Hopital Raymond Poincare Garches
Germany Universitaetsklinikum Jena Jena Thueringen
Greece University General Hospital Attikon Athens
Greece General Hospital of Thessaloniki Ippokratio Thessaloniki
Hungary Dr. Kenessey Albert Korhaz es Rendelointezet Balassagyarmat
Hungary Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia Budapest
Hungary Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika Budapest
Hungary Szent János Kórház es Észak Budai Egyesitett Kórházak Budapest
Hungary Szent Margit Kórház Budapest
Hungary Debreceni Egyetem Klinikai Központ Debrecen
Israel Pharmacy of The E. Wolfson Medical Center Holon
Israel The E. Wolfson Medical Center Holon
Israel Pharmacy of Tel Aviv Sourasky Medical Center Tel Aviv
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Lebanon American University of Beirut Medical Center Beirut
Lebanon Saint George Hospital - University Medical Center Beirut
Malaysia Hospital Raja Perempuan Zainab II Kota Bharu Kelantan
Philippines Cebu Doctors' University Hospital Cebu City Cebu
Philippines Perpetual Succour Hospital Cebu City Cebu
Philippines Manila Doctors Hospital Manila
Philippines Metropolitan Medical Center Manila
Philippines University of Santo Tomas Hospital Manila
Philippines Philippine Children's Medical Center Quezon City
Philippines St. Luke's Medical Center Quezon City
Romania Centrul Medical Unirea Bucuresti
Romania Spitalul Clinic de Urgente pentru Copii "Sf. Maria" Iasi
Russian Federation FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia Moscow
Russian Federation FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia Moscow
Russian Federation Nizhmedklinika Nizhniy Novgorod Nizhegorodskaya Oblast
Russian Federation Perm State Medical University n. a. acad. E.A. Vagner Perm Permskiy KRAY
Russian Federation Perm State Medical University n. a. acad. E.A. Vagner Perm
Russian Federation "Baltiyskaya Medicyna" LLC Saint Petersburg
Russian Federation St. Petersburg State Pediatric Medical University Saint Petersburg
Russian Federation LLC Medical Technologies Saint-Petersburg
Russian Federation LLC Medical Technologies Saint-Petersburg
Russian Federation RSBHI Smolensk Regional Clinical Hospital Smolensk
Russian Federation SHI Central Clinical Medical Unit Ulyanovsk
Russian Federation SHI Central Clinical Medical Unit Ulyanovsk
Russian Federation SHI Ulyanovsk Regional Children's Clinical Hospital n. a. Y.F.Goryachev Ulyanovsk
Russian Federation MAI Children's City Clinical Hospital 9 Yekaterinburg
Serbia Mother and Child Healthcare Institute Dr Vukan Cupic Belgrade
Serbia University Children's Hospital Belgrade Belgrade
Serbia Institute for Child and Youth Healthcare of Vojvodina Novi Sad Vojvodina
Spain Hospital Universitario Miguel Servet Zaragoza
Taiwan Chang Gung Memorial Hospital- Kaohsiung branch Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan National Taiwan University Hospital Taipei
Thailand Siriraj Hospital, Faculty of Medicine, Mahidol University Bangkoknoi Bangkok
Thailand Phramongkutklao Hospital Ratchathevee Bangkok
Turkey Eskisehir Osmangazi Universitesi Tip Fakultesi Eskisehir
Turkey Izmir Tepecik Training and Research Hospital Izmir Konak
Turkey Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi Trabzon
Ukraine Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5" Dnipro
Ukraine Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia" Dnipro
Ukraine Ivano-Frankivska oblasna dytiacha klinichna likarnia Ivano-Frankivsk
Ukraine DZ "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam Kyiv
Ukraine Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,viddilennia neirokhirurhii #2 Uzhgorod
United States The University of Texas Health Science Center at Houston Houston Texas
United States Pediatric Epilepsy Center of Central Florida Orlando Florida
United States Pediatric Neurology, PA Orlando Florida
United States Road Runner Research, Ltd. San Antonio Texas
United States Pediatric Epilepsy & Neurology Specialists, PA Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Belarus,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  China,  France,  Germany,  Greece,  Hungary,  Israel,  Korea, Republic of,  Lebanon,  Malaysia,  Philippines,  Romania,  Russian Federation,  Serbia,  Spain,  Taiwan,  Thailand,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Other 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. Day 1 up to End of study (EOS) (maximum Day 25)
Other 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)
Other 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)
Other 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)
Other 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)
Other 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)
Other 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)
Other 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)
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). Day 1 up to Day 14
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. Day 1 up to Day 14
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