A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset Seizures
Overview
- Phase
- Phase 4
- Intervention
- Perampanel
- Conditions
- Epilepsy, Partial
- Sponsor
- Eisai Inc.
- Primary Endpoint
- Change from baseline in latency to persistent sleep (LPS) using Polysomnography (PSG)
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
Brief Summary
This will be a multi-center, randomized, double-blind, placebo-controlled, crossover study to evaluate the effects of 2007/Fycompa (perampanel) on sleep, in subjects with well controlled partial onset seizures (on an antiepileptic drug [AED] monotherapy) who are experiencing sleep onset insomnia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have a diagnosis of epilepsy with partial onset seizures with or without secondary generalization, according to the ILAE Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history, with chart confirmation of previous EEG that is consistent with localization-related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history).
- •Subjects will be well controlled (defined as less than 1 seizure every 28 days) for a period of at least 3 months on a current AED monotherapy (defined as a single AED taken for at least 28 days before Screening), and have no history of AED polytherapy.
- •Male or female subjects, at least 18 years and no more than 50 years of age at the time of informed consent
- •Body Mass Index of 18 to 30 kg/m2
- •Meets Diagnostic and Statistical Manual-5 criteria for Insomnia Disorder:
- •Complains of dissatisfaction with nighttime sleep in the form of difficulty getting to sleep or difficulty staying asleep
- •Frequency of complaint is at least 3 times per week
- •Duration of complaint is at least 3 months
- •Associated with complaint of daytime impairment
- •Confirmed problems with sleep onset insomnia as evidenced by response to "Time to Fall Asleep" question on the PSQI at Screening of at least 45 minutes
Exclusion Criteria
- Not provided
Arms & Interventions
Arm A: First on Perampanel with a crossover to Placebo
Treatment Arm A will initially receive perampanel 2 mg QD titrated up to 4 mg QD and finally to 6 mg QD with a crossover to placebo.
Intervention: Perampanel
Arm A: First on Perampanel with a crossover to Placebo
Treatment Arm A will initially receive perampanel 2 mg QD titrated up to 4 mg QD and finally to 6 mg QD with a crossover to placebo.
Intervention: Placebo
Arm B: First on Placebo with a crossover to Perampanel
Treatment Arm B will initially receive placebo with a crossover to perampanel 2 mg QD titrated up to 4 mg QD and finally to 6 mg QD.
Intervention: Perampanel
Arm B: First on Placebo with a crossover to Perampanel
Treatment Arm B will initially receive placebo with a crossover to perampanel 2 mg QD titrated up to 4 mg QD and finally to 6 mg QD.
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline in latency to persistent sleep (LPS) using Polysomnography (PSG)
Time Frame: Baseline, week 5 and week 14
Secondary Outcomes
- Change from baseline in Sleep Efficiency (SE) using Polysomnography (PSG)(Baseline, week 5 and week 14)
- Change from baseline in Subjective Sleep onset Latency (SSOL) using Pittsburgh Sleep Quality Index (PSQI)(Baseline, week 5 and week 14)
- Mean reciprocal reaction time on Psychomotor Vigilance Task (PVT) to assess sustained attention(Baseline, week 5 and week 14)
- Short delay and long delay verbal recall using Rey Auditory Verbal Learning Test (RAVLT)(Baseline, week 5 and week 14)
- Measure number of seizures using Seizure Diary(baseline up to 18 weeks)
- Measure severity of suicidal ideation and behavior by eC-SSRS Electronic version of the Columbia Suicide Severity Rating Scale(baseline up to 18 weeks)
- Safety and tolerability of Perampanel as a measure of Adverse Events/ Serious Adverse Events(baseline up to 18 weeks)