Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis

17-002396

To evaluate if transcranial magnetic stimulation can be used as a biomarker in Amyotrophic Lateral sclerosis (ALS).

2018-12-04

2020-08-01

2020-09-01

Completed

Early phase I

22

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. -

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Matching placebo', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 22, 'type': 'ACTUAL'}}

2024-02-22