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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03020797
• Other study ID #: Eisai-01
• Status: Terminated
• Phase: N/A
• Start date: January 12, 2017
• Est. completion date: February 8, 2023

Study information

• Verified date: May 2023
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: February 8, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• Perampanel

• Placebo Oral Tablet

Locations

Country	Name	City	State
United States	Stony Brook University Medical Center	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events		9 months
Secondary	Efficacy as measured by change in ALSFRS-R score (ALS functional rating scale-revised);		9 months