A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: July 12, 2011
Last updated: January 22, 2015
Last verified: December 2014
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.
Seizure Disorder Generalized Tonic Clonic
Drug: placebo comparator
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures
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), extension period (38 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), extension period (38 weeks) ] [ Designated as safety issue: No ]
- Safety and tolerability as a measure of Adverse Event/Serious Adverse Events [ Time Frame: Baseline through 159 weeks ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
up to 8 mg, oral tablet, once daily
Placebo Comparator: placebo
Drug: placebo comparator
oral tablet, once daily
This study consists of core study (17 weeks) and extension phase (142 weeks).
|Ages Eligible for Study:
||12 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Ages 12 years and older
- 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
- 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
- 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
- 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).
- 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
- A ketogenic diet will be allowed as long as the subject has been on this diet for 5 weeks prior to randomization
- A history of status epilepticus that required hospitalization within 12 months prior to Baseline
- Seizure clusters where individual seizures cannot be counted
- A history of psychogenic seizures
- Concomitant diagnosis of Partial Onset Seizures (POS)
- Progressive neurological disease
- Clinical diagnosis of Lennox-Gastaut syndrome
- 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 euqal 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.
- 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
- Concomitant use of barbiturates (except for seizure control indication) within 30 days prior to Baseline
- 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
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393743
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 12, 2011
||January 22, 2015
||United States: Food and Drug Administration
Keywords provided by Eisai Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 07, 2015
Central Nervous System Diseases
Nervous System Diseases
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