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

February 20, 2024 updated by: Bjorn E. Oskarsson, Mayo Clinic
To evaluate if transcranial magnetic stimulation can be used as a biomarker in Amyotrophic Lateral sclerosis (ALS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose
Perampanel 4mg PO x1
Drug: Perampanel
Oral tablet
Other Names:
  • Fycompa
Placebo Comparator: Placebo
Receiving placebo
Other: Placebo
Placebo (not drug)
Experimental: High dose
Perampanel 8 mg PO x1
Drug: Perampanel
Oral tablet
Other Names:
  • Fycompa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor threshold (MT)
Time Frame: at 4 hours post dose
Transcranial Magnetic stimulation motor threshold change from baseline
at 4 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Bjorn E Oskarsson, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2018

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

December 28, 2018

First Submitted That Met QC Criteria

January 2, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-002396

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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