Amyotrophic Lateral SclerosisNCT06069934
A Second Intermediate-Size Expanded Access Protocol (EAP) for Pridopidine in People With Amyotrophic Lateral Sclerosis (Pridopidine EAP 2)
A study testing Pridopidine in people with Amyotrophic Lateral Sclerosis, run by Prilenia at 32 sites in 2 countries.
Trial summary
Protocol PL101-ALS501: This EAP will provide access to pridopidine for up to 200 patients with ALS who are ineligible for clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Pridopidine
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 32 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States31 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Lahey Hospital Medical Center
Burlington, Massachusetts, 08105
Northwestern University
Chicago, Illinois, 60611
OhioHealth
Columbus, Ohio, 43214
Texas Neurology
Dallas, Texas, 75206
UT Southwestern Medical Center
Dallas, Texas, 75390
Essentia Health
Duluth, Minnesota, 55805
Duke University
Durham, North Carolina, 27705
Nova Southeastern University
Fort Lauderdale, Florida, 33314
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
The University of Kansas Medical Center
Kansas City, Kansas, 66160
University of California, San Diego Health
La Jolla, California, 92037-0886
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Hospital for Special Care
New Britain, Connecticut, 06053
Columbia University
New York, New York, 10032
UC Irvine
Orange, California, 92868
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, 19140
Barrow Neurological Institute
Phoenix, Arizona, 85013
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic Rochester
Rochester, Minnesota, 55905
California Pacific Medical Center - Forbes Norris MDA/ALS Research Center
San Francisco, California, 94109
Washington University
St Louis, Missouri, 63110
Stony Brook University Hospital
Stony Brook, New York, 11794
SUNY Upstate
Syracuse, New York, 13210
University of South Florida
Tampa, Florida, 33612
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Expanded Access Protocol (EAP) for Pridopidine in People With Amyotrophic Lateral Sclerosis (PL101-ALS501)
Protocol PL101-ALS501: This EAP will provide access to pridopidine for up to 200 patients with ALS who are ineligible for clinical trials.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Pridopidine
- Keywords
- Amyotrophic Lateral Sclerosis, Pridopidine, Lou Gehrig's disease, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Dementia, Dyskinesias, Movement Disorders, Heredodegenerative Disorders, Nervous System, Neurodegenerative Diseases, Cognition Disorders, Neurocognitive Disorders, Mental Disorders
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Dementia, Dyskinesias, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PridopidineDrug
Pridopidine 45 mg hard gelatin capsules once daily p.o. (or via feeding tube)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Prilenia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069934
- Sponsor's protocol ID
- PL101-ALS501
- Status last verified
- Apr 2025
- First submitted
- 27 Sep 2023
- Last updated
- 18 May 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Protocol (EAP) for Pridopidine in People With Amyotrophic Lateral Sclerosis (PL101-ALS501)
- ClinicalTrials.gov ID
- NCT06069934
- Acronym / sponsor ID
- PL101-ALS501
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, Pridopidine, Lou Gehrig's disease, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Dementia
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- PrileniaIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Protocol PL101-ALS501: This EAP will provide access to pridopidine for up to 200 patients with ALS who are ineligible for clinical trials.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PridopidinePridopidine 45 mg hard gelatin capsules once daily p.o. (or via feeding tube) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
Related trials for Amyotrophic Lateral Sclerosis
RecruitingPhase 3
Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
Amyotrophic Lateral Sclerosis
Active, not recruitingObservational study
PREVENT ALL ALS Study
Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Study to Learn About the Safety of BIIB147 and Its Effects in Adults With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
RecruitingObservational study
Development of Targeted RNA-Seq for Amyotrophic Lateral Sclerosis Diagnosis
Amyotrophic Lateral Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pridopidine in people with Amyotrophic Lateral Sclerosis, run by Prilenia at 32 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.