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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perampanel
Placebo Oral Tablet
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Stony Brook University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

perampanel

placebo

Arm Description

perampanel 2mg QD for 2 weeks perampanel 4mg QD for 2 weeks perampanel 6mg QD for 2 weeks perampanel 8mg QD for 30 weeks

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

Outcomes

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);

Full Information

First Posted
December 15, 2016
Last Updated
May 3, 2023
Sponsor
Stony Brook University
Collaborators
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03020797
Brief Title
A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Official Title
A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
1) Enrolment below study target and 2) too many subjects had early termination due to disease progression.
Study Start Date
January 12, 2017 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
February 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
Collaborators
Eisai Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
perampanel
Arm Type
Experimental
Arm Description
perampanel 2mg QD for 2 weeks perampanel 4mg QD for 2 weeks perampanel 6mg QD for 2 weeks perampanel 8mg QD for 30 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Perampanel
Other Intervention Name(s)
Fycompa
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Efficacy as measured by change in ALSFRS-R score (ALS functional rating scale-revised);
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 may be on stable dose of edaravone for at least 30 days, otherwise agree to not initiate edaravone 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 active malignancy 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurcan Gursoy, MD
Organizational Affiliation
Stony Brook Medicine Dept. of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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