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

To measure the effect on motor threshold (MT) by transcranial magnetic stimulation (TMS) after a single dose of perampanel at two dose levels.

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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