Status:
COMPLETED
Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis
Lead Sponsor:
Mayo Clinic
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
December 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03793868
Start Date
December 4 2018
End Date
September 1 2020
Last Update
February 22 2024
Active Locations (1)
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1
Mayo Clinic
Jacksonville, Florida, United States, 32224