A Second Intermediate-Size Expanded Access Protocol (EAP) for Pridopidine in People With Amyotrophic Lateral Sclerosis (Pridopidine EAP 2)
NCT ID: NCT06069934
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
NCT07322003
A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
NCT01281631
HEALEY ALS Platform Trial - Regimen D Pridopidine
NCT04615923
A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS)
NCT05039099
Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)
NCT00931944
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pridopidine
Pridopidine 45 mg hard gelatin capsules once daily p.o. (or via feeding tube)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Massachusetts General Hospital
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
National Institutes of Health (NIH)
NIH
Prilenia
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
University of California, San Diego Health
La Jolla, California, United States
UC Irvine
Orange, California, United States
California Pacific Medical Center - Forbes Norris MDA/ALS Research Center
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Hospital for Special Care
New Britain, Connecticut, United States
Nova Southeastern University
Fort Lauderdale, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Lahey Hospital Medical Center
Burlington, Massachusetts, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Essentia Health
Duluth, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Columbia University
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
SUNY Upstate
Syracuse, New York, United States
Duke University
Durham, North Carolina, United States
OhioHealth
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, United States
Texas Neurology
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
CHALS-CCT Program, UPR-MSC
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PL101-ALS501
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.