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AMPA Receptor Antagonist

Perampanel for Amyotrophic Lateral Sclerosis

N/A
Waitlist Available
Led By Nurcan Gursoy, MD
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
diagnosis of ALS
first clinical weakness within past 3 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

Study Summary

This trial is testing the safety and preliminary efficacy of perampanel in ALS patients. Perampanel is an oral medication that is approved by the FDA for treatment of seizures in patients with 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.

Eligible Conditions
  • ALS (Amyotrophic Lateral Sclerosis)

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with ALS (also known as Lou Gehrig's disease).
Select...
You have experienced weakness in the past three years that was diagnosed by a doctor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events
Secondary outcome measures
Efficacy as measured by change in ALSFRS-R score (ALS functional rating scale-revised);

Side effects data

From 2021 Phase 4 trial • 54 Patients • NCT03288129
28%
Dizziness
17%
Fatigue
15%
Somnolence
11%
Vomiting
9%
Nasopharyngitis
9%
Irritability
9%
Headache
7%
Nausea
7%
Ear infection
6%
Upper respiratory tract infection
6%
Balance disorder
6%
Memory impairment
6%
Aggression
6%
Depression
6%
Oropharyngeal pain
2%
Mental status changes
2%
Sudden unexplained death in epilepsy
2%
Transient ischaemic attack
2%
Suicidal ideation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Perampanel 12 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: perampanelExperimental Treatment1 Intervention
perampanel 2mg QD for 2 weeks perampanel 4mg QD for 2 weeks perampanel 6mg QD for 2 weeks perampanel 8mg QD for 30 weeks
Group II: placeboPlacebo Group1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perampanel
FDA approved

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
213 Previous Clinical Trials
39,515 Total Patients Enrolled
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
154,008 Total Patients Enrolled
Nurcan Gursoy, MDPrincipal Investigator - Stony Brook Medicine Dept. of Neurology
Stony Brook University Medical Center
Trakya University (Medical School)
Cleveland Clinic Fndn (Residency)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is considered a suitable candidate for this investigation?

"For individuals to be eligible for this study, they must have been diagnosed with amyotrophic lateral sclerosis and between 18-80 years of age. Currently, the team is looking to recruit around 60 volunteers."

Answered by AI

Are there any extant investigations that include Perampanel as a component?

"Presently, 11 clinical trials are underway to evaluate the efficacy of perampanel. Of these active studies, none have reached Phase 3 yet. Primarily based out of New york City, there are 93 locations offering this therapy across the United States."

Answered by AI

Has a similar experiment been undertaken before?

"Currently, 11 active trials for the drug Perampanel are being conducted in 51 cities spanning 9 countries. These tests commenced in 2017 under the auspices of Eisai Inc., and included 60 participants who completed their N/A stage with success. Since then, a further 222 experiments have been concluded."

Answered by AI

Are the parameters of this research open to those above 35 years old?

"To qualify for this clinical trial, patients must be aged between 18 and 80. An additional 47 studies are available for minors and 402 extra trials have been created to assess elderly populations."

Answered by AI

Are interested individuals currently being accepted into this trial?

"According to clinicaltrials.gov, this medical research is currently recruiting suitable candidates and was first posted on December 1st 2017 with the latest update occurring on April 28th 2021."

Answered by AI

How many test subjects are enrolled in this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this scientific investigation is open for enrolment and was initially published on December 1st 2017 with its last update posted in late April 2021. The study requires 60 volunteers from one medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Nurcan Gursoy 2017. "A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03020797.
~1 spots leftby Apr 2025
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