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

Mayo Clinic

Status and phase: Completed; Early Phase 1

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Other: Placebo; Drug: Perampanel

Study type: Interventional

Funder types: Other

Identifiers

NCT03793868

17-002396

Details and patient eligibility

About

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

Full description

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

Enrollment: 22 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 3 patient groups, including a placebo group

Low dose

Experimental group

Description:

Perampanel 4mg PO x1

Treatment:

Drug: Perampanel

Placebo

Placebo Comparator group

Description:

Receiving placebo

Treatment:

Other: Placebo

High dose

Experimental group

Description:

Perampanel 8 mg PO x1

Treatment:

Drug: Perampanel