Amyotrophic Lateral Sclerosis
Conditions
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.
Interventions
DRUGPerampanel
Oral tablet
OTHERPlacebo
Placebo (not drug)
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Matching placebo
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. A probable laboratory supported, probable or definitive ALS diagnosis by revised El Escorial criteria. 2. Sporadic or familial ALS. 3. Ages of 18-70. 4. Agree to use reliable contraception 5. Randomization will occur after a baseline MT has been established; any subject in whom a MT cannot be established will be excluded. 6. Caregiver willing to report adverse behavioral events. -
Exclusion criteria
1. History of epilepsy. 2. Significant laboratory abnormality (AST or alanine aminotransferase \>3x upper limit of normal, or glomerular filtration rate \<60) 3. History of aggressive behavior. 4. Subject unwilling to abstain from alcohol for 2 weeks after each dosing. 5. History of drug abuse in the last 5 years 6. 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. 7. Skull defect or other physical contraindication for TMS 8. Pacemaker or implanted defibrillator 9. 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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor threshold (MT) | at 4 hours post dose | Transcranial Magnetic stimulation motor threshold change from baseline |
Countries
United States
Outcome results
None listed