To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset Seizures

NCT02220972 | Withdrawn Phase 4

• 1 other identifier: E2007-A001-408
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy, Partial

Keywords

Epilepsy; Partial Onset Seizures; Insomnia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in latency to persistent sleep (LPS) using Polysomnography (PSG)

  Baseline, week 5 and week 14

Secondary Outcomes (7)

• 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

Study Arms (2)

Arm A: First on Perampanel with a crossover to Placebo

EXPERIMENTAL

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.

Drug: Perampanel; Drug: Placebo

Arm B: First on Placebo with a crossover to Perampanel

EXPERIMENTAL

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.

Drug: Perampanel; Drug: Placebo

Interventions

Perampanel DRUG

Arm A: First on Perampanel with a crossover to Placebo; Arm B: First on Placebo with a crossover to Perampanel

Placebo DRUG

Arm A: First on Perampanel with a crossover to Placebo; Arm B: First on Placebo with a crossover to Perampanel

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Confirmed problems with sleep onset insomnia as evidenced by habitual median sSOL of at least 45 minutes obtained from sleep diary responses for the last consecutive 7 days of the Screening/Baseline Period
• Confirmed problems with sleep onset insomnia as evidenced by LPS of at least 20 minutes on the baseline PSG
• Provide written informed consent, signed by the subject before entering the study or undergoing any study procedures
• Willing and able to comply with all aspects of the protocol
• Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin \[B-hCG\] or a human chorionic gonadotropin \[hCG\] test with a minimum sensitivity of 25 IU/L or equivalent units of B-hCG \[or hCG\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.

You may not qualify if:

• Hypersensitivity to any component of Fycompa
• Subjects with other sleep problems (except for sleep onset or mixed sleep onset and sleep maintenance insomnia) based on history, standard sleep questionnaires, and PSG at Screening.
• Subjects with a diagnosis of a sleep-related breathing disorder, apnea-hypopnea index of more than 15, periodic limb movement disorder of more than 15, restless legs syndrome, nightmare disorder, sleep terror disorder, sleepwalking disorder, REM behavior disorder, narcolepsy, or circadian rhythm sleep disorder.
• Subjects with current evidence of unstable psychotic disorder, major depressive disorder, bipolar disorder, or generalized anxiety disorder based on a psychiatric interview at Screening, or subjects diagnosed with psychotic disorder or major depressive disorder within 2 years before Screening based on clinical history
• Subjects on strong cytochrome P450 (CYP) 3A inducers other than AEDs (eg, rifampin, St. John's Wort)
• Subjects on EIAEDs: carbamazepine, oxcarbazepine, and phenytoin or eslicarbazepine (presumed EIAED)
• Using a prescription or over the counter medication for the purpose of treating sleep disturbance, including sedating antihistamines, within 14 days before dosing
• Transmeridian travel across more than 3 time zones in the 2 weeks before Screening, or planning to travel across more than 3 time zones during the study
• Excessive caffeine use (defined as more than 4 cups of coffee a day, or its equivalent)
• Shift workers, defined as subjects who typically start work hours after 16:00 (4 pm) or before 4:00 (4 am)
• Any history of a medical condition or concomitant medical condition that in the opinion of the investigator(s) would compromise the subject's ability to safely complete the study, including significantly abnormal laboratory results or any physical or mental condition that prevents compliance with the protocol
• Use of illegal recreational drugs or recent history (within 2 years before the Screening Visit) of alcohol or drug/solvent dependency or abuse or a positive screen for drugs of abuse using a standard Urine Drug Screen at Screening
• A clinically significant electrocardiogram (ECG) abnormality, including a prolonged QT interval/corrected QT interval defined as more than 450 msec based on an ECG at Screening
• Currently enrolled in another clinical study or participated in any clinical study with an investigational drug, biologic, or device within 1 month before Screening (Visit 1), or within approximately 5 half-lives of the previous investigational compound, whichever is longer
• Previous use of perampanel or participated in previous perampanel studies

Sponsors & Collaborators

• Eisai Inc.: lead

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy; Sleep Initiation and Maintenance Disorders

Interventions

perampanel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: March 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 10, 2015

Record last verified: 2015-01