Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Perampanel
Placebo
Sponsored by
About this trial
This is an interventional other trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
Inclusion Criteria:
- A probable laboratory supported, probable or definitive ALS diagnosis by revised El Escorial criteria.
- Sporadic or familial ALS.
- Ages of 18-70.
- Agree to use reliable contraception
- Randomization will occur after a baseline MT has been established; any subject in whom a MT cannot be established will be excluded.
- Caregiver willing to report adverse behavioral events. -
Exclusion Criteria:
- History of epilepsy.
- Significant laboratory abnormality (AST or alanine aminotransferase >3x upper limit of normal, or glomerular filtration rate <60)
- History of aggressive behavior.
- Subject unwilling to abstain from alcohol for 2 weeks after each dosing.
- History of drug abuse in the last 5 years
- Other severe medical conditions, including psychiatric conditions, which would cause an increased risk in the opinion of the investigator, including but not limited to renal failure and liver failure.
- Skull defect or other physical contraindication for TMS
- Pacemaker or implanted defibrillator
- Inability to take study capsule by mouth
Females only: Subject is pregnant [as confirmed by a positive serum human chorionic gonadotropin (hCG) test for females of reproductive potential (FRP) only], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow use of reliable contraception.
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Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Low dose
Placebo
High dose
Arm Description
Perampanel 4mg PO x1
Receiving placebo
Perampanel 8 mg PO x1
Outcomes
Primary Outcome Measures
Motor threshold (MT)
Transcranial Magnetic stimulation motor threshold change from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03793868
Brief Title
Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis
Official Title
Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
To evaluate if transcranial magnetic stimulation can be used as a biomarker in Amyotrophic Lateral sclerosis (ALS).
Detailed Description
To measure the effect on motor threshold (MT) by transcranial magnetic stimulation (TMS) after a single dose of perampanel at two dose levels.
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
Other
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This is a pilot study for the assessment of transcranial magnetic stimulation as a biomarker for ALS and to obtain information to guide a dose selection for future biomarker driven Phase 2 studies of Perampanel in ALS.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Matching placebo
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose
Arm Type
Experimental
Arm Description
Perampanel 4mg PO x1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Receiving placebo
Arm Title
High dose
Arm Type
Experimental
Arm Description
Perampanel 8 mg PO x1
Intervention Type
Drug
Intervention Name(s)
Perampanel
Other Intervention Name(s)
Fycompa
Intervention Description
Oral tablet
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo (not drug)
Primary Outcome Measure Information:
Title
Motor threshold (MT)
Description
Transcranial Magnetic stimulation motor threshold change from baseline
Time Frame
at 4 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A probable laboratory supported, probable or definitive ALS diagnosis by revised El Escorial criteria.
Sporadic or familial ALS.
Ages of 18-70.
Agree to use reliable contraception
Randomization will occur after a baseline MT has been established; any subject in whom a MT cannot be established will be excluded.
Caregiver willing to report adverse behavioral events. -
Exclusion Criteria:
History of epilepsy.
Significant laboratory abnormality (AST or alanine aminotransferase >3x upper limit of normal, or glomerular filtration rate <60)
History of aggressive behavior.
Subject unwilling to abstain from alcohol for 2 weeks after each dosing.
History of drug abuse in the last 5 years
Other severe medical conditions, including psychiatric conditions, which would cause an increased risk in the opinion of the investigator, including but not limited to renal failure and liver failure.
Skull defect or other physical contraindication for TMS
Pacemaker or implanted defibrillator
Inability to take study capsule by mouth
Females only: Subject is pregnant [as confirmed by a positive serum human chorionic gonadotropin (hCG) test for females of reproductive potential (FRP) only], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow use of reliable contraception.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjorn E Oskarsson, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis
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