Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02220972
Recruitment Status : Withdrawn
First Posted : August 20, 2014
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

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.

Condition or disease Intervention/treatment Phase
Epilepsy, Partial Drug: Perampanel Drug: Placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016


Arm Intervention/treatment
Experimental: 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.
Drug: Perampanel
Drug: Placebo
Experimental: 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.
Drug: Perampanel
Drug: Placebo



Primary Outcome Measures :
  1. Change from baseline in latency to persistent sleep (LPS) using Polysomnography (PSG) [ Time Frame: Baseline, week 5 and week 14 ]

Secondary Outcome Measures :
  1. Change from baseline in Sleep Efficiency (SE) using Polysomnography (PSG) [ Time Frame: Baseline, week 5 and week 14 ]
  2. Change from baseline in Subjective Sleep onset Latency (SSOL) using Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, week 5 and week 14 ]
  3. Mean reciprocal reaction time on Psychomotor Vigilance Task (PVT) to assess sustained attention [ Time Frame: Baseline, week 5 and week 14 ]
  4. Short delay and long delay verbal recall using Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: Baseline, week 5 and week 14 ]
  5. Measure number of seizures using Seizure Diary [ Time Frame: baseline up to 18 weeks ]
  6. Measure severity of suicidal ideation and behavior by eC-SSRS Electronic version of the Columbia Suicide Severity Rating Scale [ Time Frame: baseline up to 18 weeks ]
  7. Safety and tolerability of Perampanel as a measure of Adverse Events/ Serious Adverse Events [ Time Frame: baseline up to 18 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. 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.
  3. Male or female subjects, at least 18 years and no more than 50 years of age at the time of informed consent
  4. Body Mass Index of 18 to 30 kg/m2
  5. Meets Diagnostic and Statistical Manual-5 criteria for Insomnia Disorder:

    1. Complains of dissatisfaction with nighttime sleep in the form of difficulty getting to sleep or difficulty staying asleep
    2. Frequency of complaint is at least 3 times per week
    3. Duration of complaint is at least 3 months
    4. Associated with complaint of daytime impairment
  6. 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
  7. 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
  8. Confirmed problems with sleep onset insomnia as evidenced by LPS of at least 20 minutes on the baseline PSG
  9. Provide written informed consent, signed by the subject before entering the study or undergoing any study procedures
  10. Willing and able to comply with all aspects of the protocol
  11. 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.
  12. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
  13. Females of childbearing potential must not participate in a conception process (ie, active attempt to become pregnant or to impregnate, in vitro fertilization) and must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia), for at least 4 weeks before dosing, throughout the entire study period and for 4 weeks after study drug discontinuation. If currently abstinent, the subject must agree to use a double-barrier method as described above if she becomes sexually active during the study period or for 4 weeks after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and must continue to use the same contraceptive during the study and for 4 weeks after study drug discontinuation.

Exclusion criteria

  1. Hypersensitivity to any component of Fycompa
  2. 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.
  3. 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.
  4. 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
  5. Subjects on strong cytochrome P450 (CYP) 3A inducers other than AEDs (eg, rifampin, St. John's Wort)
  6. Subjects on EIAEDs: carbamazepine, oxcarbazepine, and phenytoin or eslicarbazepine (presumed EIAED)
  7. Using a prescription or over the counter medication for the purpose of treating sleep disturbance, including sedating antihistamines, within 14 days before dosing
  8. 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
  9. Excessive caffeine use (defined as more than 4 cups of coffee a day, or its equivalent)
  10. Shift workers, defined as subjects who typically start work hours after 16:00 (4 pm) or before 4:00 (4 am)
  11. 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
  12. 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
  13. 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
  14. 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
  15. Previous use of perampanel or participated in previous perampanel studies
  16. Any suicidal ideation with intent with or without a plan at Screening or Baseline or within 6 months before Screening (ie, answering 'Yes' to questions on the Suicidal Ideation section of the electronic version of the Columbia Suicide Severity Rating Scale [eC-SSRS])
  17. Suicide attempt(s) within approximately the last 2 years or suicidal ideation within the last 6 months before the Screening visit (using the Suicidal Behavior Section of the eC-SSRS)
  18. Evidence of significant active hepatic disease. Stable elevations of liver enzymes, alanine aminotransferase and aspartate aminotransferase due to concomitant medication(s) will be allowed if they are less than 3 times the upper limit of normal
  19. Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject's safety or interfere with the study assessments
  20. Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
  21. Presence of an implanted vagal nerve stimulator
  22. Have had multiple drug allergies or a severe drug reaction to an AED, including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity
Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02220972    
Other Study ID Numbers: E2007-A001-408
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: January 2015
Keywords provided by Eisai Inc.:
Epilepsy
Partial Onset Seizures
Insomnia
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Sleep Initiation and Maintenance Disorders
Seizures
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Mental Disorders
Neurologic Manifestations
Signs and Symptoms