Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis
Perampanel
+ Placebo
Amyotrophic Lateral Sclerosis+8
+ Central Nervous System Diseases
+ Metabolic Diseases
Other Study
Summary
Study start date: December 4, 2018
Actual date on which the first participant was enrolled.To measure the effect on motor threshold (MT) by transcranial magnetic stimulation (TMS) after a single dose of perampanel at two dose levels.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.22 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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. \-
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location