A Second Intermediate-Size Expanded Access Protocol (EAP) for Pridopidine in People With Amyotrophic Lateral Sclerosis (Pridopidine EAP 2)
Purpose
Protocol PL101-ALS501: This EAP will provide access to pridopidine for up to 200 patients with ALS who are ineligible for clinical trials.
Condition
- Amyotrophic Lateral Sclerosis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Amyotrophic Lateral Sclerosis (ALS): - Sporadic or familial ALS. - Patient does not qualify for clinical trials of pridopidine or as per site investigator's opinion, and is not medically or geographically suitable for other clinical trials. - Capable of providing informed consent and complying with study procedures, in the site investigator's opinion. - Patient has established care with a physician at a specialized ALS center involved in the study and will maintain this clinical care throughout the duration of the EAP. - Pridopidine naive patients must have a life expectancy of at least 6 months in the site investigator's opinion.
Exclusion Criteria
ALS: - 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 prohibited medications within the 4 weeks prior to baseline. - 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, based on site investigator's judgment, 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 or cell-based 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.
Study Design
- Phase
- Study Type
- Expanded Access
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35233
Phoenix 5308655, Arizona 5551752 85013
La Jolla 5363943, California 5332921 92037-0886
Orange 5379513, California 5332921 92868
San Francisco 5391959, California 5332921 94109
Aurora 5412347, Colorado 5417618 80045
New Britain 4839292, Connecticut 4831725 06053
Fort Lauderdale 4155966, Florida 4155751 33314
Jacksonville 4160021, Florida 4155751 32224
Tampa 4174757, Florida 4155751 33612
Chicago 4887398, Illinois 4896861 60611
Iowa City 4862034, Iowa 4862182 52242
Kansas City 4273837, Kansas 4273857 66160
Boston 4930956, Massachusetts 6254926 02114
Burlington 4931737, Massachusetts 6254926 08105
Worcester 4956184, Massachusetts 6254926 01655
Duluth 5024719, Minnesota 5037779 55805
Minneapolis 5037649, Minnesota 5037779 55455
Rochester 5043473, Minnesota 5037779 55905
St Louis 4407066, Missouri 4398678 63110
New York 5128581, New York 5128638 10032
Stony Brook 5139865, New York 5128638 11794
Syracuse 5140405, New York 5128638 13210
Durham 4464368, North Carolina 4482348 27705
Columbus 4509177, Ohio 5165418 43214
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19140
Dallas 4684888, Texas 4736286 75206
Dallas 4684888, Texas 4736286 75390
Richmond 4781708, Virginia 6254928 23298
Milwaukee 5263045, Wisconsin 5279468 53226
San Juan 4568127, Puerto Rico 00935
More Details
- NCT ID
- NCT06069934
- Status
- No longer available
- Sponsor
- Prilenia
Detailed Description
ALS: Pridopidine will be given at a dose of 45 mg twice daily p.o. (or via feeding tube) over a 2-week up-titration period; followed by pridopidine 45 mg twice daily p.o. (or via feeding tube) for the remainder of the treatment period (through Week 104). Each patient will be followed for 2 years with regularly scheduled visits. The screening and baseline visits will be performed in person; subsequent visits may occur in person or remotely. Recommended in-person visits will occur at Weeks 12, 52, 78, and end of treatment (Week 104 or early termination). If the patient is unable to complete the visits in person, these visits may also be completed remotely.