A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 12 years and older
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Trial locations and contacts

117 sites in 7 countries.

About this study

Official title: A Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures

Conditions

Partial-onset Seizures

Being tested

Perampanel, Placebo

Keywords

Partial-onset Seizures, partial seizures, seizure, epilepsy

Medical subject headings

Seizures, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• PerampanelDrug

  Also called E2007

  Core study: 4 milligram (mg) group- Week 0 Once daily 2 milligram per day (mg/day), Week 1 to Week 18 Once daily 4 mg/day; 8 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 to Week 18 Once daily 8 mg/day; 12 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 Once daily 8 mg/day, Week 4 Once daily 10 mg/day, Week 5 to Week 18 Once daily 12 mg/day.

  Extension study: 4 mg group- Week 19 to Week 22 Once daily 4 mg/day, Week 23 Once daily 6 mg/day, Week 24 Once daily 8 mg/day, Week 25 Once daily 10 mg/day, Week 26 to Week 75 or more Once daily 12 mg/day; 8 mg group- Week 19 to Week 22 Once daily 8 mg/day, Week 23 Once daily 10 mg/day, Week 24 to Week 75 or more Once daily 12 mg/day; 12 mg group- Week 19 to Week 75 or more Once daily 12 mg/day.

• PlaceboDrug

  Core study: Week 0 to Week 18 Once daily placebo.

  Extension study:

  Week 19 to Week 22 Once daily placebo, Week 23 Once daily perampanel 2 mg/day, Week 24 Once daily perampanel 4 mg/day, Week 25 Once daily perampanel 6 mg/day, Week 26 Once daily perampanel 8 mg/day, Week 27 Once daily perampanel 10 mg/day, Week 28 to Week 75 or more Once daily perampanel 12 mg/day.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)

   Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. All partial seizure included simple partial seizures without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalized seizures. A simple partial seizure takes place on one side of the brain. Usually, people experiencing a simple partial seizure do not lose consciousness or awareness. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain. The seizure affects people's awareness and may cause them to lose consciousness.

   Measured: Baseline, Week 19

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted13 Jun 2012 (estimated)
2. Study start15 May 2012
3. Primary completion15 Sep 2014
4. Study completion28 May 2020

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (2)Papers the sponsor has linked to this study.
• Other trials for Partial-onset SeizuresStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.