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: October 14, 2014
Last verified: October 2014

July 12, 2011
October 14, 2014
September 2011
May 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01393743 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Seizure Disorder Generalized Tonic Clonic
  • Drug: perampanel
    up to 8 mg, oral tablet, once daily
  • Drug: placebo comparator
    oral tablet, once daily
  • Experimental: perampanel
    Intervention: Drug: perampanel
  • Placebo Comparator: placebo
    Intervention: Drug: placebo comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
165
April 2017
May 2014   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   United States,   Australia,   Thailand,   China,   Czech Republic,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Netherlands,   Poland,   Serbia
 
NCT01393743
E2007-G000-332
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Francesco Bibbiani Eisai Inc.
Eisai Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP