A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
- Conditions
- Partial Onset Seizures
- Interventions
- Registration Number
- NCT02072824
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Drug Level 1 Pregabalin Dose Level 1 - Study Drug Level 2 Pregabalin Dose Level 2 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase Day 1 up to Day 14 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).
- Secondary Outcome Measures
Name Time Method 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 Day 1 up to Day 14 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.
Trial Locations
- Locations (68)
Road Runner Research, Ltd.
🇺🇸San Antonio, Texas, United States
Pediatric Neurology, PA
🇺🇸Orlando, Florida, United States
Universitaetsklinikum Jena
🇩🇪Jena, Thueringen, Germany
Pediatric Epilepsy Center of Central Florida
🇺🇸Orlando, Florida, United States
Pediatric Epilepsy & Neurology Specialists, PA
🇺🇸Tampa, Florida, United States
UZ Brussel
🇧🇪Brussels, Bruxelles Capitale, Belgium
The First Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Pharmacy of Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Szent Margit Kórház
🇭🇺Budapest, Hungary
Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
🇭🇺Budapest, Hungary
University Clinical Centre of the Republic of Srpska
🇧🇦Banja Luka, Bosnia and Herzegovina
Beijing Children's Hospital
🇨🇳Beijing, China
UMHAT "Sveti Georgi" Ltd.
🇧🇬Plovdiv, Bulgaria
Hopital Raymond Poincare
🇫🇷Garches, France
UMHAT Dr. Georgi Stranski Ltd.
🇧🇬Pleven, Bulgaria
St. Luke's Medical Center
🇵🇭Quezon City, Philippines
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Institute for Child and Youth Healthcare of Vojvodina
🇷🇸Novi Sad, Vojvodina, Serbia
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
St. Petersburg State Pediatric Medical University
🇷🇺Saint Petersburg, Russian Federation
"Baltiyskaya Medicyna" LLC
🇷🇺Saint Petersburg, Russian Federation
University General Hospital Attikon
🇬🇷Athens, Greece
General Hospital of Thessaloniki Ippokratio
🇬🇷Thessaloniki, Greece
Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,viddilennia neirokhirurhii #2
🇺🇦Uzhgorod, Ukraine
Siriraj Hospital, Faculty of Medicine, Mahidol University
🇹🇭Bangkoknoi, Bangkok, Thailand
Phramongkutklao Hospital
🇹🇭Ratchathevee, Bangkok, Thailand
Perpetual Succour Hospital
🇵🇭Cebu City, Cebu, Philippines
GU Republican Scientific and Practical Center Mother and Child
🇧🇾Minsk, Belarus
Metropolitan Medical Center
🇵🇭Manila, Philippines
University Children's Hospital Belgrade
🇷🇸Belgrade, Serbia
Chang Gung Memorial Hospital- Kaohsiung branch
🇨🇳Kaohsiung, Taiwan
Children's Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
🇷🇺Moscow, Russian Federation
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Dr. Kenessey Albert Korhaz es Rendelointezet
🇭🇺Balassagyarmat, Hungary
Szent János Kórház es Észak Budai Egyesitett Kórházak
🇭🇺Budapest, Hungary
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Központ
🇭🇺Debrecen, Hungary
Pharmacy of The E. Wolfson Medical Center
🇮🇱Holon, Israel
The E. Wolfson Medical Center
🇮🇱Holon, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, 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, Malaysia
Cebu Doctors' University Hospital
🇵🇭Cebu City, Cebu, Philippines
University of Santo Tomas Hospital
🇵🇭Manila, Philippines
Manila Doctors Hospital
🇵🇭Manila, Philippines
Philippine Children's Medical Center
🇵🇭Quezon City, Philippines
Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
🇷🇴Iasi, Romania
Centrul Medical Unirea
🇷🇴Bucuresti, Romania
Nizhmedklinika
🇷🇺Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation
Perm State Medical University n. a. acad. E.A. Vagner
🇷🇺Perm, Russian Federation
RSBHI Smolensk Regional Clinical Hospital
🇷🇺Smolensk, Russian Federation
LLC Medical Technologies
🇷🇺Saint-Petersburg, Russian Federation
SHI Ulyanovsk Regional Children's Clinical Hospital n. a. Y.F.Goryachev
🇷🇺Ulyanovsk, Russian Federation
SHI Central Clinical Medical Unit
🇷🇺Ulyanovsk, Russian Federation
MAI Children's City Clinical Hospital 9
🇷🇺Yekaterinburg, Russian Federation
Mother and Child Healthcare Institute Dr Vukan Cupic
🇷🇸Belgrade, Serbia
China Medical University Hospital
🇨🇳Taichung, Taiwan
Izmir Tepecik Training and Research Hospital
🇹🇷Izmir, Konak, Turkey
Eskisehir Osmangazi Universitesi Tip Fakultesi
🇹🇷Eskisehir, Turkey
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
DZ "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam
🇺🇦Kyiv, 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
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
🇹🇷Trabzon, Turkey