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NCT03020797
A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)
NA trial testing Perampanel in Amyotrophic Lateral Sclerosis in 12 participants. Terminated before completion.
31 January 2023
Quick facts
| Lead sponsor | Stony Brook University |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 12 January 2017 |
| Primary completion | 31 January 2023 |
| Estimated completion | 8 February 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Perampanel (PERAMPANEL) — full drug profile →
- Placebo Oral Tablet — full drug profile →
Conditions studied
- Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →
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):
-
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 -
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:
- PubMed search for NCT03020797
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Perampanel
Trials testing the same drug.
- NCT07284069 — Senicapoc and Perampanel for Newly Diagnosed Glioblastoma · EARLY_PHASE1 · recruiting
- NCT05684978 — Efficacy and Safety of Perampanel in the Treatment of Refractory Status Epilepticus · Phase 4 · terminated
- NCT06401707 — PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest · Phase 2 · recruiting
- NCT04309721 — Perampanel in Focal Status Epilepticus · Phase 3 · terminated
- NCT05533814 — A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizure · Phase 4 · completed
Other recruiting trials for Amyotrophic Lateral Sclerosis
Currently open trials in the same condition.
- NCT07502677 — Diagnostic Accuracy of SleepImage Technology for Detecting Respiratory Failure in Patients With Amyotrophic Lateral Scle · recruiting
- NCT07478172 — Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease · NA · recruiting
- NCT07204977 — Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS) · Phase 1 · active not recruiting
- NCT07290062 — A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants · Phase 1 · recruiting
- NCT07259980 — A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD- · recruiting
Other Stony Brook University trials
Trials by the same sponsor.
- NCT07478250 — First Responder Safety Training (FiRST) · NA · not yet recruiting
- NCT07076342 — The Role of mGluR5 in CBT-I · Phase 4 · recruiting
- NCT07009691 — Hydrogen Water Intervention With Heart Rate Variability as an Outcome Biomarker in ME/CFS · NA · recruiting
- NCT07114900 — Randomized Controlled Physical Activity App Intervention for Black Women · Phase 3 · active not recruiting
- NCT05245227 — Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03020797 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Stony Brook University
- Last refreshed: 6 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03020797.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing