Perampanel Transcranial Magnetic Stimulation (TMS) in Amyotrophic Lateral Sclerosis (ALS)
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 17-002396
NCT ID: NCT03793868
Sponsor Protocol Number: 17-002396
About this study
The purpose of this study is to evaluate the potential to use TMS as a way of functionally assessing target engagement in an efficacy study of Perampanel as a treatment for ALS. The study will also determine if there is a correlation between Perampanel dose and TMS MT.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- A probable laboratory supported, probable or definitive ALS diagnosis by revised El Escorial criteria.
- Sporadic or familial ALS.
- Ages of 18-70.
- Agree to use reliable contraception
- Randomization will occur after a baseline MT has been established; any subject in whom a MT cannot be established will be excluded.
- Caregiver willing to report adverse behavioral events.
Exclusion Criteria:
- History of epilepsy.
- Significant laboratory abnormality (AST or ALT >3xULN, or GFR <60)
- History of aggressive behavior.
- Subject unwilling to abstain from alcohol for 2 weeks after each dosing.
- History of drug abuse in the last 5 years
- Other severe medical including psychiatric condition which would cause an increased risk in the opinion of the investigator, including but not limited to renal failure and liver failure.
- Skull defect or other physical contraindication for TMS
- Pacemaker or implanted defibrillator
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Bjorn Oskarsson, M.D. |
Closed for enrollment |
|
More information
Publications
-
Cortical hyperexcitability is a feature of amyotrophic lateral sclerosis (ALS) and cortical excitability can be measured using transcranial magnetic stimulation (TMS). Resting motor threshold (MT) is a measure of cortical excitability, largely driven by glutamate. Perampanel, a glutamate α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor blocker, is predicted to increase the cortical excitability threshold. This study aimed to evaluate TMS to functionally assess target engagement in a study of perampanel in ALS.
Read More on PubMed