Pregabalin in subjects with Primary Generalised Tonic-Clonic seizures
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, parallel group, multi-center trial of Pregabalin as adjunctive therapy in paediatric and adult subjects with primary generalised tonic-clonic seizures
IRAS ID
115372
Contact name
Rajiv Mohanraj
Contact email
Sponsor organisation
Pfizer Inc
Eudract number
2010-023263-18
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 (also called fits). Seizures occur as a result of abnormally and excessive electrical discharges from the brain cells (or neurons). Epilepsy is classed into generalised and focal – generalised 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 characterised by stiffening (‘tonic’) followed by shaking or 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, a proportion of patients continue to have seizures in spite of treatment with currently available AEDs, and there is a need to identify new treatments for this group of patients.
Pregabalin is an AED currently licensed for the treatment of focal epilepsies. The purpose of this study is to assess the efficacy of Pregabalin in controlling PGTCS when used in patients taking 1 to 3 other AEDs and continuing to experience seizures. Patients who enrol in the study will be randomized to receive either Pregabalin dose level 1 (5 mg/kg/day, maximum 300 mg/day), pregabalin dose level 2 (10 mg/kg/day maximum 600 mg/day) or a placebo (dummy pill). This is will be a double blind study, which means that neither the patient nor the study team will be aware which of the above 3 treatments the patient is receiving. This is a multicentre study, taking place across Europe, United States, India and China, which will aim to recruit 168 patients aged 5-65 years.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
13/NW/0496
Date of REC Opinion
3 Sep 2013
REC opinion
Further Information Favourable Opinion