Perampanel Transcranial Magnetic Stimulation (TMS) in Amyotrophic Lateral Sclerosis (ALS)

Overview

About this study

The purpose of this study is to evaluate the potential to use TMS as a way of functionally assessing target engagement in an efficacy study of Perampanel as a treatment for ALS. The study will also determine if there is a correlation between Perampanel dose and TMS MT.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 ALT >3xULN, or GFR <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 including psychiatric condition 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
  10. 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Bjorn Oskarsson, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20323059

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