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A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Sponsor
Stony Brook University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03020797
Collaborator
Eisai Inc. (Industry)
60
Enrollment
1
Location
2
Arms
118.6
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a pilot trial to test perampanel (Fycompa; Eisai, Inc.) in ALS patients. The investigators will focus on safety and preliminary signs of efficacy. Perampanel is approved by the FDA for treatment of seizures in patients with epilepsy. In this study, perampanel will be used off-label for adults with ALS at an oral medication dose on the low end of the recommended dose range for epilepsy. This study will consist of two treatments arms: perampanel and matching placebo randomized at a 1:1 ratio. Subjects will receive medication for 9 months.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Actual Study Start Date :
Jan 12, 2017
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: perampanel

perampanel 2mg QD for 2 weeks perampanel 4mg QD for 2 weeks perampanel 6mg QD for 2 weeks perampanel 8mg QD for 30 weeks

Drug: Perampanel
Other Names:
  • Fycompa

    		•
    Placebo Comparator: placebo

    placebo 1 tablet QD for 2 weeks placebo 2 tablets QD for 2 weeks placebo 3 tablets QD for 2 weeks placebo 4 tablets QD for 2 weeks

    Drug: Placebo Oral Tablet

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of treatment-emergent adverse events [9 months]

    Secondary Outcome Measures

    1. Efficacy as measured by change in ALSFRS-R score (ALS functional rating scale-revised); [9 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. diagnosis of ALS

    2. first clinical weakness within past 3 years

    3. slow vital capacity >= 60% of predicted within 1 month of treatment

    4. may be on stable dose of riluzole for at least 30 days, or otherwise agree to not initiate riluzole for duration of the trial

    5. may be on stable dose of edaravone for at least 30 days, otherwise agree to not initiate edaravone for duration of the trial

    6. can travel to Stony Brook to receive medical care

    7. must have a monitor who can be contacted at regular intervals to report on subject's clinical/psychiatric status

    Exclusion Criteria:

    1. use of tracheostomy or mechanical ventilation within last 3 months

    2. hepatic insufficiency or abnormal liver function

    3. renal insufficiency

    4. clinically significant psychiatric disorder

    5. active malignancy

    6. history of HIV, clinically significant chronic hepatitis, or other active infection

    7. history of stomach or intestinal surgery or condition that could interfere with absorption, distribution, metabolism or secretion of study drug

    8. history of alcohol or substance abuse within 3 months prior to entry (subjects will be instructed to refrain from alcohol during the study)

    9. use of strong cytochrome P4503A inhibitors or inducers, anticonvulsants or other drugs known to interact strongly with perampanel.

    10. pregnancy or lactation

    11. clinically significant medical condition (other than ALS) that would pose a risk to the subject if they were to participate

    12. know hypersensitivity to perampanel

    13. currently participating, or has participated in a study with an investigation or marketed compound within 3 months of entry

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stony Brook University Medical Center Stony Brook New York United States 11794-8121

    Sponsors and Collaborators

    • Stony Brook University
    • Eisai Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nurcan Gursoy, Clinical Assistant Professor, Stony Brook University
    ClinicalTrials.gov Identifier:
    NCT03020797
    Other Study ID Numbers:
    • Eisai-01
    First Posted:
    Jan 13, 2017
    Last Update Posted:
    Apr 29, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Motor Neuron Disease
    Amyotrophic Lateral Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Apr 29, 2021