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

Study Purpose:

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Active, currently recruiting

Phase:

Phase 0

Study Chair(s)/Principal Investigator(s):

Nurcan Gursoy, MD, Stony Brook University Medical Center

Clinicaltrials.gov ID (11 digit #):

NCT03020797

Neals Affiliated?

No

Coordinating Center Contact Information

Stony Brook University Medical Center
Diana Kaell, BA / .(JavaScript must be enabled to view this email address) / 631-444-7832
Nurcan Gursoy, MD / .(JavaScript must be enabled to view this email address) / 631-444-2599
Stony Brook
New York, New York 11794 United States

Full Study Summary:

Study Sponsor:

Stony Brook University

Participant Duration:

Subjects will receive medication for 9 months.

Estimated Enrollment:

60

Estimated Study Start Date:

12/01/2016

Estimated Study Completion Date:

12/31/2018

Posting Last Modified Date:

Date Study Added to alsconsortium.org:

02/24/2017
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    80

    Min Vital Capacity (% predicted normal):

    60

    Time since Symptom Onset:

    <36

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    diagnosis of ALS
    first clinical weakness within past 3 years
    slow vital capacity >= 60% of predicted within 1 month of treatment
    may be on stable dose of riluzole for at least 30 days, or otherwise agree to not initiate riluzole for duration of the trial
    can travel to Stony Brook to receive medical care
    must have a monitor who can be contacted at regular intervals to report on subject's clinical/psychiatric status

    Exclusion Criteria:

    use of tracheostomy or mechanical ventilation within last 3 months
    hepatic insufficiency or abnormal liver function
    renal insufficiency
    clinically significant psychiatric disorder
    history of malignancy < 5 years prior to entry
    history of HIV, clinically significant chronic hepatitis, or other active infection
    history of stomach or intestinal surgery or condition that could interfere with absorption, distribution, metabolism or secretion of study drug
    history of alcohol or substance abuse within 3 months prior to entry (subjects will be instructed to refrain from alcohol during the study)
    use of strong cytochrome P4503A inhibitors or inducers, anticonvulsants or other drugs known to interact strongly with perampanel.
    pregnancy or lactation
    clinically significant medical condition (other than ALS) that would pose a risk to the subject if they were to participate
    know hypersensitivity to perampanel
    currently participating, or has participated in a study with an investigation or marketed compound within 3 months of entry

  • Site Contact Information

    Stony Brook
    Diana Kaell, BA / .(JavaScript must be enabled to view this email address) / 631-444-7832
    New York , New York 11794
    United States