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

Study Purpose:

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

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Biomarkers/Imaging , transcranial magnetic stimulation

Study Status:

Enrolling

Phase:

Phase I

Study Chair(s)/Principal Investigator(s):

Bjorn E. Oskarsson, MD, Mayo Clinic

Clinicaltrials.gov ID (11 digit #):

NCT03793868

Neals Affiliated?

No

Coordinating Center Contact Information

Mayo Clinic
Carla Palmucci / .(JavaScript must be enabled to view this email address) / 905-953-3182
.(JavaScript must be enabled to view this email address) Jacksonville, Florida 32224 United States

Full Study Summary:

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

Study Sponsor:

Mayo Clinic

Participant Duration:

Estimated Enrollment:

24

Estimated Study Start Date:

12/04/2018

Estimated Study Completion Date:

12/01/2019

Posting Last Modified Date:

01/31/2019

Date Study Added to alsconsortium.org:

01/31/2019
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    70

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    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.

  • Site Contact Information

    Mayo Clinic
    Jany Paulett / .(JavaScript must be enabled to view this email address) / 904-953-3730
    Jacksonville, Florida 32224
    United States