Overview

This trial is active, not recruiting.

Condition seizure disorder generalized tonic clonic
Treatments perampanel, placebo comparator
Phase phase 3
Sponsor Eisai Inc.
Start date September 2011
End date May 2014
Trial size 165 participants
Trial identifier NCT01393743, E2007-G000-332

Summary

This study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of perampanel on Primary Generalized Tonic Clonic (PGTC) seizure frequency in adolescents and adults maintained on one to two stable antiepileptic drugs.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
perampanel
up to 8 mg, oral tablet, once daily
(Placebo Comparator)
placebo comparator
oral tablet, once daily

Primary Outcomes

Measure
Percent change from baseline in PGTC seizure frequency per 28 days
time frame: from baseline over the Titration and Maintenance Periods (17 weeks)

Secondary Outcomes

Measure
Responder Rate for all subtypes of primary generalized seizure frequency per 28 days
time frame: Maintenance Period relative to baseline (17 weeks)

Eligibility Criteria

Male or female participants at least 12 years old.

Inclusion: Ages 12 years and older 1. Clinical diagnosis of PGTC seizures (with or without other subtypes of primary generalized seizures) and experiencing greater than or equal to 3 PGTC seizures during the 8-week period prior to randomization 2. Have had a routine electroencephalogram (EEG) prior to or during the Baseline Period with electroencephalographic features consistent with primary generalized epilepsy; other concomitant anomaly should be explained by adequate past medical history 3. On a fixed dose of one to a maximum of three concomitant antiepileptic drugs (AEDs) for a minimum of 30 days prior to Baseline; only one inducer AED (i.e., carbamazepine, oxcarbazepine, or phenytoin) out of the maximum of two AEDs will be allowed 4. A vagal nerve stimulator (VNS) will be allowed, but it must have been implanted greater than or equal to 5 months prior to Baseline (stimulator parameters cannot be changed for 30 days prior to Baseline and for the duration of the study). 5. Have had a computed tomography (CT) or magnetic resonance imaging (MRI) within the last 10 years (for adults) and 5 years (for adolescents) that ruled out a progressive cause of epilepsy 6. A ketogenic diet will be allowed as long as the subject has been on this diet for 5 weeks prior to randomization Exclusion: 1. A history of status epilepticus that required hospitalization within 12 months prior to Baseline 2. Seizure clusters where individual seizures cannot be counted 3. A history of psychogenic seizures 4. Concomitant diagnosis of Partial Onset Seizures (POS) 5. Progressive neurological disease 6. Clinical diagnosis of Lennox-Gastaut syndrome 7. If felbamate is used as a concomitant AED, subjects must be on felbamate for at least 2 years, with a stable dose for 60 days prior to Baseline. They must not have a history of white blood cell (WBC) count below less than or equal to 2500/microL (2.50 1E+09/L), platelets less than 100,000/microL, liver function tests (LFTs) greater than 3 times the upper limit of normal (ULN), or other indication of hepatic or bone marrow dysfunction while receiving felbamate. 8. Concomitant use of vigabatrin: Subjects who took vigabatrin in the past must be discontinued for approximately 5 months prior to Baseline, and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in an automated visual perimetry test 9. Concomitant use of barbiturates (except for seizure control indication) within 30 days prior to Baseline 10. Use of intermittent rescue benzodiazepines (i.e., one to two doses over a 24-hour period considered one-time rescue) two or more times within the 30 days prior to Baseline

Additional Information

Official title A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Eisai Inc..