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NCT03020797

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

Terminated NA Last updated 6 May 2023
What this trial tests

NA trial testing Perampanel in Amyotrophic Lateral Sclerosis in 12 participants. Terminated before completion.

Timeline
12 January 2017
Primary endpoint
31 January 2023
8 February 2023

Quick facts

Lead sponsorStony Brook University
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment12
Start date12 January 2017
Primary completion31 January 2023
Estimated completion8 February 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Stony Brook University

Who can join

Adults 18 to 80, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Improving clinical trial outcomes in amyotrophic lateral sclerosis.
    Kiernan MC, Vucic S, Talbot K, McDermott CJ, et al · · 2021 · cited 205× · PMID 33340024 · DOI 10.1038/s41582-020-00434-z
  2. Metabolomics Biomarkers: A Strategy Toward Therapeutics Improvement in ALS.
    Lanznaster D, de Assis DR, Corcia P, Pradat PF, et al · · 2018 · cited 38× · PMID 30619076 · DOI 10.3389/fneur.2018.01126

Verify or expand the search:

Other trials of Perampanel

Trials testing the same drug.

Other recruiting trials for Amyotrophic Lateral Sclerosis

Currently open trials in the same condition.

Other Stony Brook University trials

Trials by the same sponsor.

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Data sources for this page

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