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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03793868
• Other study ID #: 17-002396
• Status: Completed
• Phase: Early Phase 1
• Start date: December 4, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• Perampanel
Oral tablet

Other:
• Placebo
Placebo (not drug)

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Oskarsson B, Mauricio EA, Shah JS, Li Z, Rogawski MA. Cortical excitability threshold can be increased by the AMPA blocker Perampanel in amyotrophic lateral sclerosis. Muscle Nerve. 2021 Aug;64(2):215-219. doi: 10.1002/mus.27328. Epub 2021 May 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor threshold (MT)	Transcranial Magnetic stimulation motor threshold change from baseline	at 4 hours post dose

External Links

•   Mayo Clinic Clinical Trials