Valeant announces full enrolment of Restore1 trial

Valeant Pharmaceuticals has announced that it has completed its patient enrolment in the first of its Restore trials assessing the safety and efficacy of retigabine as a treatment for partial onset epilepsy.

The phase III trials will measure the safety and efficacy of the compound in refractory partial-onset epilepsy patients who are currently receiving up to three concomitant antiepileptic treatments.

Valeant reports that 306 patients have been signed up for the Restore1 study which is being conducted at 49 sites across the world.

Retigabine is a first-in-class neuronal potassium channel opener currently in phase III of clinical development as an adjunctive treatment for patients with refractory epilepsy suffering from partial-onset seizures.

Wesley P Wheeler, president of research and development at Valeant, said: “Achieving full enrolment in the Restore1 trial is an important milestone in the development of retigabine.”

He added that over four-fifths of patients enrolled in the study eligible to enter the open-label extension investigation following on from the Restore trials have chosen to do so, while the firm expects the Restore1 study to be completed during the first quarter of 2008.

In April 2007, Valeant reported positive phase II clinical trial results for retigabine, with patients administered with the compound showing a reduction in seizure rates.