A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
Completed · Phase 3 · Has a placebo group
Conditions studied: Generalized Tonic Clonic Seizures
In brief
The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.
Key facts
- Study ID
- NCT01747915
- Run by
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- People needed
- 219
- Starts
- 2013-04-03
- Expected to finish
- 2019-02-20
- Last updated by the study team
- 2021-01-20
Who can join
Age: 5 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Seizures classified as Primary Generalized Tonic Clonic Seizures
- Must have at least 1 PGTC seizure in the 8 weeks prior to screening
- Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least 1 PGTC in each 4-week period of the baseline phase
- Currently receiving adequate and stable dosage of 1 to 3 anti-epileptic treatments (stable within 28 days of screening)
- Signed informed consent and assent if a minor
- Ability to comply with daily seizure and dosing diary requirements and all study procedures
You may not qualify if…
- A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness
- Focal seizures (simple partial, complex partial, or partial becoming secondarily generalized)
- Status Epilepticus within 1 year prior to screening
- Lennox-Gastaut syndrome, infantile spasms, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome
- Seizures related to drugs, alcohol, or acute medical illness
- Any change in anti-epileptic treatment regimen (type of medication or dose; VNS alteration) within 28 days of the screening visit or during the baseline phase
- Progressive or potentially progressive structural CNS lesion or a progressive encephalopathy.
- Progressive inborn errors of metabolism.
Where it is running
- Pediatric Epilepsy Center of Central Florida — Orlando, Florida, United States
- Pediatric Neurology, PA — Orlando, Florida, United States
- Medsol Clinical Research Center — Port Charlotte, Florida, United States
- Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States
- Alexian Brothers Center for Psychiatric Research — Hoffman Estates, Illinois, United States
- Chinmay K. Patel, D.O. — Hoffman Estates, Illinois, United States
- St. Alexius Medical Center — Hoffman Estates, Illinois, United States
- Ohio Clinical Research Partners, LLC — Canton, Ohio, United States
- Road Runner Research, Ltd — San Antonio, Texas, United States
- Scott & White Memorial Hospital and Clinic — Temple, Texas, United States
- Rainier Clinical Research Center, Inc. — Renton, Washington, United States
- Medizinische Universitaet Innsbruck — Innsbruck, Austria
- AKH Linz — Linz, Austria
- UZ Vitebsk Regional Childrens Clinical Centre — Vitebsk, Belarus
- UZ Vitebsk Regional Childrens Clinical Centre — Vitebsk, Belarus
- University Clinical Center Sarajevo — Sarajevo, Canton Sarajevo, Bosnia and Herzegovina
- University Clinical Center Tuzla — Tuzla, Canton Tuzla, Bosnia and Herzegovina
- University Clinical Hospital Mostar — Mostar, Herzegovinaneretva Canton, Bosnia and Herzegovina
- Public Health Institution Hospital Dr Mladen Stojanovic — Prijedor, Republika Srpska, Bosnia and Herzegovina
- Multiprofile Hospital for Active Treatment Puls AD — Blagoevgrad, Bulgaria
- DCC Sv. Pantaleimon OOD — Pleven, Bulgaria
- Military Medical Academy - Multiprofile Hospital for Active Treatment — Pleven, Bulgaria
- MHAT Central Onco Hospital OOD — Plovdiv, Bulgaria
- Medical Center Teodora — Rousse, Bulgaria
- Axcess Medical Research — Loxahatchee Groves, Florida, United States
Full record on ClinicalTrials.gov
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