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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Stony Brook University
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Nurcan Gursoy, Stony Brook University
ClinicalTrials.gov Identifier:
NCT03020797
First received: December 15, 2016
Last updated: January 11, 2017
Last verified: December 2016
  Purpose
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.

Condition Intervention
Amyotrophic Lateral Sclerosis
Drug: Perampanel
Drug: Placebo Oral Tablet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Incidence of treatment-emergent adverse events [ Time Frame: 9 months ]

Secondary Outcome Measures:
  • Efficacy as measured by change in ALSFRS-R score (ALS functional rating scale-revised); [ Time Frame: 9 months ]

Estimated Enrollment: 60
Study Start Date: December 2016
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: perampanel
perampanel 2mg QD for 2 weeks perampanel 4mg QD for 2 weeks perampanel 6mg QD for 2 weeks perampanel 8mg QD for 30 weeks
Drug: Perampanel
Other Name: Fycompa
Placebo Comparator: placebo
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
Drug: Placebo Oral Tablet

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. can travel to Stony Brook to receive medical care
  6. 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. history of malignancy < 5 years prior to entry
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03020797

Contacts
Contact: Diana Kaell, BA 631-444-7832 diana.kaell@stonybrookmedicine.edu
Contact: Nurcan Gursoy, MD 631-444-2599 nurcan.gursoy@stonybrookmedicine.edu

Locations
United States, New York
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794-8121
Contact: Diana Kaell, BA    631-444-7832    diana.kaell@stonybrookmedicine.edu   
Contact: Nurcan Gursoy, MD    631-444-2599    nurcan.gursoy@stonybrookmedicine.edu   
Sub-Investigator: Dennis Choi, MD         
Sub-Investigator: Rahman Pourmand, MD         
Sponsors and Collaborators
Stony Brook University
Eisai Inc.
  More Information

Responsible Party: Nurcan Gursoy, Clinical Assistant Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT03020797     History of Changes
Other Study ID Numbers: Eisai-01
Study First Received: December 15, 2016
Last Updated: January 11, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on March 28, 2017