A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
Completed · Phase 3 · Has a placebo group
Conditions studied: Partial Onset Seizures
In brief
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.
Key facts
- Study ID
- NCT02072824
- Run by
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- People needed
- 175
- Starts
- 2014-09-16
- Expected to finish
- 2018-03-13
- Last updated by the study team
- 2021-01-20
Who can join
Age: 0 and older, up to 3. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pediatric Neurology, PA — Orlando, Florida, United States
- Pediatric Epilepsy & Neurology Specialists, PA — Tampa, Florida, United States
- The University of Texas Health Science Center at Houston — Houston, Texas, United States
- Road Runner Research, Ltd. — San Antonio, Texas, United States
- GU Republican Scientific and Practical Center Mother and Child — Minsk, Belarus
- UZ Brussel — Brussels, Brussels Capital, Belgium
- University Clinical Centre of the Republic of Srpska — Banja Luka, Bosnia and Herzegovina
- UMHAT Dr. Georgi Stranski Ltd. — Pleven, Bulgaria
- UMHAT "Sveti Georgi" Ltd. — Plovdiv, Bulgaria
- The First Bethune Hospital of Jilin University — Changchun, Jilin, China
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China
- Beijing Children's Hospital — Beijing, China
- Hopital Raymond Poincare — Garches, France
- Universitaetsklinikum Jena — Jena, Thuringia, Germany
- University General Hospital Attikon — Athens, Greece
- General Hospital of Thessaloniki Ippokratio — Thessaloniki, Greece
- Dr. Kenessey Albert Korhaz es Rendelointezet — Balassagyarmat, Hungary
- Szent János Kórház es Észak Budai Egyesitett Kórházak — Budapest, Hungary
- Szent Margit Kórház — Budapest, Hungary
- Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika — 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
- Pediatric Epilepsy Center of Central Florida — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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