A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01393743
First received: July 12, 2011
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Seizure Disorder Generalized Tonic Clonic
Drug: perampanel
Drug: placebo comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Percent change from baseline in PGTC seizure frequency per 28 days [ Time Frame: from baseline over the Titration and Maintenance Periods (17 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responder Rate for all subtypes of primary generalized seizure frequency per 28 days [ Time Frame: Maintenance Period relative to baseline (17 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: September 2011
Estimated Study Completion Date: June 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: perampanel Drug: perampanel
up to 8 mg, oral tablet, once daily
Placebo Comparator: placebo Drug: placebo comparator
oral tablet, once daily

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393743

  Show 131 Study Locations
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Francesco Bibbiani Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01393743     History of Changes
Other Study ID Numbers: E2007-G000-332
Study First Received: July 12, 2011
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Central Nervous System

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014