Post Marketing Study of Perampanel in Patients with Epilepsy

A Prospective, Multicenter, Post-marketing Surveillance to Assess Safety & Efficacy of Perampanel in Indian Patients as an Adjunctive Treatment inPartial Onset Seizures with or Without Secondary Generalized Seizures in Patients with Epilepsy Aged 12 years or older.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/01/016844

Enrollment

200

Registered

2019-01-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G401- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures

Interventions

Intervention1: Perampanel (Fycompa): Perampanel (Fycompa) Tablet. 2mg/4mg/6mg/8mg/10mg/12mg Once a day for 6 months. Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients age greater than or equal to 12 years at the time of informed consent 2. Patients prescribed perampanel for the adjunctive treatment of partial onset seizures based on independent clinical judgment of treating physicians. 3. Patients who provide informed consent to the treating physician.

Exclusion criteria

Exclusion criteria: 1. Participation in another study involving administration of an investigational drug or device whilst participating in this observational study 2. Hypersensitivity [allergic] to perampanel

Design outcomes

Primary

Measure	Time frame
To assess the safety of perampanel in the treatment of partial onset seizures in patients of age 12 years and older with epilepsy.Timepoint: 6 Months	—

Secondary

Measure	Time frame
ô??¸ To assess the change in seizure frequency with perampanel as adjunctive treatment of partial onset seizures in patients of age 12 years and older with epilepsy ô??¸ To assess the responder rate (50% seizure frequency reduction) with perampanel as adjunctive treatment of partial onset seizures in patients of age 12 years and older with epilepsy ô??¸ To evaluate proportion of seizure free patients at the end of 3-months, and 6-months and last 3 months during the treatment period.Timepoint: 3 and 6 months	—

Measure

Time frame

ô??¸ To assess the change in seizure frequency with perampanel as adjunctive treatment of partial onset seizures in patients of age 12 years and older with epilepsy ô??¸ To assess the responder rate (50% seizure frequency reduction) with perampanel as adjunctive treatment of partial onset seizures in patients of age 12 years and older with epilepsy ô??¸ To evaluate proportion of seizure free patients at the end of 3-months, and 6-months and last 3 months during the treatment period.Timepoint: 3 and 6 months

—

Countries

India

Contacts

Public ContactSeema Chaurasia

Accutest Research Laboratories (I) Pvt.Ltd.

ajay.malle@accutestglobal.com02227780718

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026