Clinical Trials

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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/26/23. Questions regarding updates should be directed to the study team contact.