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NCT03020797 · ClinicalTrials.gov registry record · NA
A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)
A NA study, sponsored by Stony Brook University.
- Terminated
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT03020797 is a NA study that was terminated before completion, run by Stony Brook University. The registered enrollment target is 12 participants.
The verdict
NCT03020797, a NA study, was terminated before completion, sponsored by Stony Brook University.
- TERMINATED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study 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.
Interventions
- DRUG Perampanel
- DRUG Placebo Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-01-12 |
| Est. Completion | 2023-02-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03020797
The ClinicalTrials.gov registry entry for NCT03020797 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stony Brook University, which has 127 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Perampanel is the first listed.
NCT03020797 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03020797 about?
NCT03020797 is a clinical study titled "A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)". 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 adult...
What is the current status of trial NCT03020797?
This trial is currently terminated. It is a NA study. The enrollment target is 12 participants. The study started on 2017-01-12. Estimated completion is 2023-02-08.
What interventions are being tested in trial NCT03020797?
The interventions under investigation include: Perampanel (DRUG), Placebo Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT03020797?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
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