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

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ClinicalTrials.gov Identifier: NCT03793868
Recruitment Status : Completed
First Posted : January 4, 2019
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Bjorn E. Oskarsson, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Perampanel Other: Placebo Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a pilot study for the assessment of transcranial magnetic stimulation as a biomarker for ALS and to obtain information to guide a dose selection for future biomarker driven Phase 2 studies of Perampanel in ALS.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Matching placebo
Primary Purpose: Other
Official Title: Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis
Actual Study Start Date : December 4, 2018
Actual Primary Completion Date : August 1, 2020
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Perampanel

Arms and Interventions
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Arm Intervention/treatment
Experimental: Low dose
Perampanel 4mg PO x1
 Drug: Perampanel
Oral tablet
Other Name: Fycompa
Placebo Comparator: Placebo
Receiving placebo
 Other: Placebo
Placebo (not drug)
Experimental: High dose
Perampanel 8 mg PO x1
 Drug: Perampanel
Oral tablet
Other Name: Fycompa


Outcome Measures
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Primary Outcome Measures :
  1. Motor threshold (MT) [ Time Frame: at 4 hours post dose ]
    Transcranial Magnetic stimulation motor threshold change from baseline


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793868


Locations
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United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Bjorn E Oskarsson, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Bjorn E. Oskarsson, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03793868    
Other Study ID Numbers: 17-002396
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020

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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
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases