A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy

Conditions

• Partial-onset Seizures
• Pediatric Epileptic Syndrome

Eligibility Criteria

Sex

ALL

Age

1 Month - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Perampanel Oral Suspension — DRUG
  Perampanel oral suspension.
• Perampanel Tablet — DRUG
  Perampanel tablet.

Study Details

The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic syndrome (Cohort 1) and partial-onset seizures (POS) (Cohort 2).

Key Dates

Start date

May 31, 2019

Status verified

Jun 2025

Primary completion

Apr 6, 2027

Completion

Dec 23, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Perampanel
  Participants aged 1 month to less than 18 years with pediatric epileptic syndrome (Cohort 1) or aged 1 month to less than 2 years with POS (Cohort 2) will receive perampanel oral suspension or perampanel tablets, once daily up to 56 weeks.

Primary Outcome Measure

Proportion of 50% Responders For All Seizures During the Maintenance Period of Core Study [ Time Frame: Week 10 to Week 23 ]

Central Contacts

• Eisai Medical Information
  +1-888-274-2378
  [email protected]

Locations (22)

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