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Epilepsy, PartialPhase 4NCT02220972

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

A Phase 4 study testing Perampanel in people with Epilepsy, Partial, run by Eisai Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Epilepsy, Partial
What is being tested?
Perampanel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2015to Aug 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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.
  • 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).
  • 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.

Who cannot join

  • 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)
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  • 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
  • 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])
  • 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)
  • 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
  • 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
  • Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
  • Presence of an implanted vagal nerve stimulator
  • Have had multiple drug allergies or a severe drug reaction to an AED, including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity

About this study

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

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.

Being tested
Perampanel, Placebo
Keywords
Epilepsy, Partial Onset Seizures, Insomnia
Medical subject headings
Epilepsies, Partial, Epilepsy, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PerampanelDrug

  • PlaceboDrug

Study groups in NCT02220972
Study groupRoleWhat they receive
Arm A: First on Perampanel with a crossover to PlaceboExperimentalTreatment 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.
Receives: Drug: Perampanel; Drug: Placebo
Arm B: First on Placebo with a crossover to PerampanelExperimentalTreatment 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.
Receives: Drug: Perampanel; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline, week 5 and week 14

Secondary outcomes (7)

  1. Change from baseline in Sleep Efficiency (SE) using Polysomnography (PSG)

    Measured: Baseline, week 5 and week 14

  2. Change from baseline in Subjective Sleep onset Latency (SSOL) using Pittsburgh Sleep Quality Index (PSQI)

    Measured: Baseline, week 5 and week 14

  3. Mean reciprocal reaction time on Psychomotor Vigilance Task (PVT) to assess sustained attention

    Measured: Baseline, week 5 and week 14

  4. Short delay and long delay verbal recall using Rey Auditory Verbal Learning Test (RAVLT)

    Measured: Baseline, week 5 and week 14

  5. Measure number of seizures using Seizure Diary

    Measured: 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

    Measured: baseline up to 18 weeks

  7. Safety and tolerability of Perampanel as a measure of Adverse Events/ Serious Adverse Events

    Measured: baseline up to 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2014 (estimated)
  2. Study startMar 2015
  3. Primary completionAug 2016 (estimated)
  4. Study completionAug 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02220972
Sponsor's protocol ID
E2007-A001-408
Status last verified
Jan 2015
First submitted
18 Aug 2014
Last updated
10 Feb 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Perampanel in people with Epilepsy, Partial, run by Eisai Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in latency to persistent sleep (LPS) using Polysomnography (PSG) (time frame: Baseline, week 5 and week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02220972.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.

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