Adjunctive treatment in partial onset seizures

Perampanel Study A prospective, multicenter, post-marketing surveillance to assess safety & efficacy of perampanel in Indian patients as an adjunctive treatment in partial onset seizures with or without secondary generalized seizures in patients with epilepsy aged 12 years or older. On 2nd December 2016, Indian drug regulatory body (DCGI) has approved the application of Perampanel as an adjunctive treatment of partial onset seizures with or without secondary generalized seizures in patients with epilepsy aged 12 years and older. This approval letter (DCGI Form 45, dated 2nd December 2016) has included the necessity to conduct a study of post-marketing surveillance (PMS) for one year.

The aim of this post-marketing trial is mainly to collect clinical information from Indian patients with epilepsy, who receive perampanel treatment, in order to assess and give information related to safety and tolerability, as well as efficacy, to Drugs Controller General – India (DCGI) to meet national regulatory requirements for therapeutic product registration. This post-marketing (Phase IV) trial organized for the collection of information related to efficacy and safety of Perampanel among the Indian patients. The drug that is going to be tested in this study contains Perampanel which is a new drug that has been manufactured for the treatment of partial onset seizures with or without secondary generalized seizures in patients with epilepsy. There is no placebo (“sugar pill”) in this study. 200 participants from the various sites of India whose data will be collected for the above mentioned study. Ramkrishna Mission Seva Pratishthan, one of the study centers for this said trial. Under the supervision of Dr. Barun Kumar Sen (Neurologist) the study was conducted and also run and management by ClinimMed lifeSciences Pvt Ltd. 20 nos. of subject’s recruited (randomized) for the above mentioned trial, the end period of the said Study is February 2020.