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

Early Phase 1

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: Placebo; Drug: Perampanel

• Registration Number: NCT03793868
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2018-12-04
• Study First Submitted: 2018-12-28
• Study First Submitted QC: 2019-01-02
• Study First Posted: 2019-01-04
• Primary Completion: 2020-08-01
• Study Completion: 2020-09-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Receiving placebo
Low dose	Perampanel	Perampanel 4mg PO x1
High dose	Perampanel	Perampanel 8 mg PO x1

Primary Outcome Measures

Name	Time	Method
Motor threshold (MT)	at 4 hours post dose	Transcranial Magnetic stimulation motor threshold change from baseline

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States