Pridopidine in Amyotrophic Lateral Sclerosis (EAP 2)
Amyotrophic Lateral Sclerosis
About this trial
This is an expanded access trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, Pridopidine, Lou Gehrig's disease
Eligibility Criteria
Inclusion Criteria: Sporadic or familial ALS. Patient does not qualify for clinical trials of pridopidine or other clinical trials for the treatment of ALS at the enrolling site Capable of providing informed consent and complying with study procedures Patient has established care with a physician at the specialized ALS center involved in the study and will maintain this clinical care throughout the duration of the EAP Life expectancy of at least 6 months. Exclusion Criteria: Confirmed prolonged Fridericia-corrected QT (QTcF) interval (>450 ms for men; >470 ms for women). Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, asymptomatic sustained ventricular tachycardia, or left bundle branch block. Known history of long QT syndrome or a first degree relative with long QT syndrome. Use of Nuedexta (>20 mg dextromethorphan and >10 mg quinidine twice daily); citalopram >20 mg/day; escitalopram >10 mg/day. Known allergy to pridopidine or any of the exipients (silicified microcrystalline cellulose, magnesium stearate). History of any clinically significant or unstable medical condition or laboratory abnormality that may interfere with assessment of the study objectives. Female who is pregnant or nursing or who plans to get pregnant during the course of the EAP Female of child-bearing potential or male unwilling or unable to use accepted methods of birth control. Use of investigational treatments for ALS (as part of participation in a clinical trial or another EAP) within 5 half-lives (if known) or 30 days (whichever is longer) prior to screening (other than pridopidine). Patient receives or has received any gene therapy Active cancer or history of cancer, except for basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years Patients who chose to take experimental medications and/or supplements, and for whom this is the only reason they are not eligible for trials.