Pregabalin Open Label Follow up study of A0081105
Research type
Research Study
Full title
A 12-month open-label study to evaluate the safety and tolerability of Pregabalin as adjunctive therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures
IRAS ID
130635
Contact name
Rajiv Mohanraj
Contact email
Sponsor organisation
Pfizer Inc. 235 East 42nd Street, New York, NY 10017
Eudract number
2011-001412-65
Clinicaltrials.gov Identifier
Research summary
Epilepsy is the most common serious neurological disorder, with a prevalence of approximately 1%. It is characterised by the tendency to have recurrent seizures (fits). Seizures occur as a result of abnormally and excessive electrical discharges from the brain cells (neurons). Epilepsy is classed into generalised and focal – generalized epilepsies cause seizures that involve both halves of the brain from the outset, and focal epilepsies cause seizures that start in a discrete area in the brain.
Primary Generalised Tonic-Clonic Seizure (PGTCS) is a type of epileptic seizure characterized by stiffening (‘tonic’) followed by shaking/twitching (‘clonic’) movements of all the limbs. Antiepileptic drugs (AEDs) work by preventing abnormal excessive discharge of electricity from neurons.
For PGTCS, sodium valproate, levetiracetam, lamotrigine, topiramate and zonisamide are the commonly used AEDs. However, some patients continue to have seizures in spite of treatment with currently available AEDs, and there is a need to identify new treatments for these patients.
In this study pregablin (an AED) will be tested to see if it helps people having primary generalised seizures and the side effects it may have over 12 months of treatment. Pregablin will be used in addition to other current drugs that patients may be taking. Although Pregabalin is approved in Europe and the USA for the treatment of several disorders, including partial onset seizures, few AED’s have been studied in patients with PGTC seizures.
The study medication, pregabalin, will be provided to all study subjects for up to 12 months. The initial dose is 150 mg/day then can be changed based upon the doctor’s opinion about seizure control and occurrence of side effects but will not exceed 600 mg/day.
There will be approximately 168 people aged between 5-65 enrolled in this study which is being conducted at approximately 120 different research sites across 28 countries.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/0055
Date of REC Opinion
7 Apr 2014
REC opinion
Further Information Favourable Opinion