Amyotrophic Lateral SclerosisPhase 3PREVAiLSNCT07322003
Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
A Phase 3 study testing Pridopidine in people with Amyotrophic Lateral Sclerosis, run by Prilenia at 55 sites in 13 countries.
Trial summary
The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Pridopidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 55 sitesin 13 countries
- Study dates
- 1 Feb 2026to Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definite ALS or Probable ALS using the El Escorial criteria.
- Symptom onset of ≤18 months at screening.
- Slow vital capacity (SVC) greater or equal to 60% predicted.
- Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening.
- Able to swallow a capsule.
Who cannot join
- Presence of tracheostomy or permanent assisted ventilation.
- Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.
- Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study.
- Clinically significant and/or unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and/or to study completion.
- Use of medications that prolong QT interval.
- Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.
- Confirmed mutation in the SOD1, FUS or C9orf72 gene.
- Pregnancy.
Trial locations and contacts
55 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
55 sites in 13 countries
United States18 sites, 18 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Wanda Sanchez, 404-727-1273, wanda.sanchez@emory.edu
- Recruiting
University of Colorado CU Anschutz Neurology
Aurora, Colorado, 80045
303-724-4644, neuroresearch@cuanschutz.edu
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Collen Kane, 410-502-6184, Ckane13@jh.edu
- Recruiting
Sean M. Healey & AMG Center for ALS
Boston, Massachusetts, 02114
Julia Stein, 617-726-1398, mghpridopidinephase3healey@mgb.org
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Candace James, candace.james@northwestern.edu
- Recruiting
Texas Neurology
Dallas, Texas, 75206
Amanda Pinal, 214-827-3610, apinal@texasneurology.com
- Recruiting
University of Kansas
Fairway, Kansas, 66205
nstaudenmier@kumc.edu
- Recruiting
Baylor College of Medicine; McNair Medical Campus
Houston, Texas, 77030
Jorge E. Zaragoza Zapiain, 713-798-0106, Jorge.ZaragozaZapiain@bcm.edu
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
- Recruiting
Somnos Clinical Research
Lincoln, Nebraska, 68506
402-770-7403, desi@somnos.com
wendy@somnos.com
- Recruiting
Eleanor and Lou Gehrig ALS Center at Columbia University
New York, New York, 10032
Arish Jamil, aj3098@cumc.columbia.edu
- Recruiting
Neuroscience Department at LKSM at Temple University
Philadelphia, Pennsylvania, 19140
Kathleen Hatala, 215-707-4171, Kathleen.hatala@tuhs.temple.edu
Christine Barr, 215-707-5440, Christine.barr@tuhs.temple.edu
- Recruiting
Barrow Neurological Institute
Phoenix, Arizona, 85013
Fulton.research@comminspirit.org
- Recruiting
California Pacific Medical Center
San Francisco, California, 94109
Christie Linh, clinicalresearch@sutterhealth.org
- Recruiting
Swedish Medical Center
Seattle, Washington, 98122
Laura Johnson, 206-320-7115, Laura.Johnson3@Swedish.org
- Recruiting
University of Washington
Seattle, Washington, 98195
- Recruiting
Washington University
St Louis, Missouri, 63110
844-257-2273, als@wustl.edu
- Recruiting
University of South Florida
Tampa, Florida, 33612
Jessica Shaw, (813) 974-9413, jessshaw@usf.edu
Italy6 sites, 6 recruiting
- Recruiting
University of Campania "Luigi Vanvitelli"
Caserta
- Recruiting
Centro Clinico NEMO Fondazione Serena Onlus - ASST Niguarda Hospital
Milan, 20126
- Recruiting
Istituto Auxologico Italiano Ospedale San Luca
Milan
Nicola Ticozzi, 390261911 ext. 2937, n.ticozzi@auxologico.it
Luca Grappiolo, 390261911 ext. 2894, luca.grappiolo@auxologico.it
- Recruiting
Azienda Ospedaliero Universitaria Di Modena
Modena
- Recruiting
University of Padova
Padova
- Recruiting
University of Torino
Torino
France5 sites, 5 recruiting
- Recruiting
CHU Lille
Lille
- Recruiting
Hôpitaux Universitaires de Marseille Timone
Marseille
- Recruiting
Centre Hospitalier Universitaire de Nice
Nice
Dr. Soriani, centredereference.neuronemoteur@cu-nice.fr
- Recruiting
Hospitalier Pitié-Salpêtrière
Paris, 75013
- Recruiting
Centre hospitalier régional universitaire de de Tours
Tours
Germany5 sites, 5 recruiting
- Recruiting
ALS outpatient department at Charité - university medicine Berlin
Berlin, 13353
Birgit Koch, Birgit.koch@charite.de
- Recruiting
ALS Clinic Bonn University
Bonn, 53127
motoneuron-ambulanz@ukbonn.de
- Recruiting
University Hospital Jena
Jena
neurologie-studien@med.uni-jena.de
- Recruiting
Universitätsklinikum Schleswig-Holstein
München
- Recruiting
University of Ulm
Ulm, 89081
Spain5 sites, 5 recruiting
- Recruiting
Hospital del Mar
Barcelona
- Recruiting
University Hospital of Bellvitge
Barcelona
- Recruiting
Hospital Universitario La Paz - Carlos III
Madrid, 28029
ela.hciii@salud.madrid.org
- Recruiting
Clinical Hospital Santiago de Compostela
Santiago de Compostela, 15706
- Recruiting
Hospital Universitari i Politècnic La Fe
Valencia, 46026
Juan F Vázquez Costa, ensayos_clinicos_ela@iislafe.es
Canada3 sites, 3 recruiting
- Recruiting
University of Alberta
Edmonton
- Recruiting
McMaster University Medical Centre
Hamilton
- Recruiting
Genge Partners
Montreal, Quebec, H4P 2N2
KMunoz@gengepartners.com
Poland3 sites, 3 recruiting
- Recruiting
Centrum Medyczne Neuromed
Bydgoszcz, 85-163
Dr. Paweł Lisewski, 0048 513904844
- Recruiting
Linden sp. z o. o. sp. k.
Krakow, 30-105
Anna Soltysiak, anna.soltysiak@cmlinden.com
- Recruiting
City Clinic Research Sp. z o.o.
Warsaw, 02-473
Magdalena Kuźma-Kozakiewicz, info@cityclinic.pl
United Kingdom3 sites, 3 recruiting
- Recruiting
King's College Hospital
London
- Recruiting
MDN Centre Queen Square Institute of Neurology
London
- Recruiting
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG
Israel2 sites, 2 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem, IL 91120
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Sweden2 sites, 2 recruiting
- Recruiting
Studieenheten Akademiskt specialistcentrum
Stockholm, 113 61
Caroline Ingre, studieenheten.slso@regionstockholm.se
- Recruiting
Umeå University Hospital
Umeå, 901 85
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Evi Parente, 0032 16 338668
Ann D'hondt, 0032 16 37 75 77
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis
The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:
Does pridopidine slow disease progression of ALS?
Researchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS.
Participants will:
Take pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks.
Visit the clinic once every 1-3 months for checkups and tests
Read the detailed description
This is a Phase 3, randomized study consisting of a double-blind placebo-controlled (DBPC) period followed by an open-label extension (OLE) to evaluate the efficacy and safety of pridopidine administered orally at a dose of 45 mg twice a day in adult participants with early and rapidly progressing ALS. Standard of care treatments (e.g. riluzole, edaravone and Nuedexta) will be allowed as long as participants are on a stable dose for at least 4 weeks prior to dosing. In the DBPC period, participants will be randomized in a 3:2 ratio to the pridopidine and placebo arms.
In the DBPC period, participants will receive pridopidine or placebo for 48 weeks. In the OLE period, all participants will receive pridopidine for 48 weeks, while maintaining the blind to their original randomization for both the participant as well as the Investigator and other clinical staff. The total study duration per participant will be 102 weeks including screening and follow up.
Throughout the study, participants will be assessed through on-site clinic visits and virtual visits (via telephone).
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Pridopidine, Placebo
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PridopidineDrug
Pridopidine hard gelatin capsule.
PlaceboDrug
Placebo hard gelatin capsule.
| Study group | Role | What they receive |
|---|---|---|
| Pridopidine | Experimental | Pridopidine hard gelatin capsules of 45 mg strength. During titration period 1 capsule taken orally in the morning for 2 weeks. During the main treatment period, 1 capsule in the morning and 1 capsule in the afternoon taken orally. Total daily dose of 90 mg. Receives: Drug: Pridopidine |
| Placebo | Placebo comparator | Placebo hard gelatin capsules. During titration period 1 capsule taken orally in the morning for 2 weeks. During the main treatment period, 1 capsule in the morning and 1 capsule in the afternoon taken orally. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline through Week 26 and Week 48 in the Revised ALS Functional Rating Scale (ALSFRS-R) total score adjusted for mortality
The ALSFRS-R encompasses 12 questions grouped into 4 domains to assess bulbar symptoms, limb and trunk functionality, respiratory symptoms, and the need for percutaneous endoscopic gastrostomy (PEG), non-invasive ventilation, or tracheostomy with invasive ventilation. Each function is scored from 0 (no ability) to 4 (normal), with a minimum total score of 0 and maximum total score of 48. Higher scores indicate better functioning.
Measured: Baseline to Week 48
Secondary outcomes (6)
Overall survival at Week 96
Time to death in days from baseline as assessed at the end of open-label extension (OLE) period
Measured: Baseline to Week 96
Change from baseline through Week 26 and Week 48 in speaking rate as measured by quantitative speech assessment in the clinic
Measured: Baseline to Week 48
Change from baseline through Week 48 in intelligibility of speech by quantitative speech assessment in the clinic.
Measured: Baseline to Week 48.
Change from baseline through Week 48 in percent predicted slow vital capacity (SVC)
SVC measures the maximal amount of air exhaled in a relaxed expiration from full inspiration to residual volume. SVC is assessed in the sitting position with a spirometer.
Measured: Baseline to Week 48
Change from baseline through Week 48 in the Bulbar subdomain of the ALSFRS-R
Measures decline in bulbar function.
Measured: Baseline to Week 48
Change from baseline through Week 48 in the Amyotrophic Lateral Sclerosis Assessment Questionnaire - 40 (ALSAQ-40)
ALSAQ-40 includes 40 items/questions with 5 discrete scales including physical mobility (10 items), activities of daily living and independence (10 items), eating and drinking (3 items), communication (7 items), and emotional reactions (10 items). The questions refer to two weeks prior to the day of the application and the answers are given according to the following variables: never, rarely, sometimes, frequently and always. The score ranges from 0 to 100; the higher the score, the worse the quality of life.
Measured: Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Feb 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2029 (estimated)
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized (3:2), double-blind, placebo-controlled study followed by an open-label extension period. During the open-label extension, all participants will receive pridopidine.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prilenia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ferrer Internacional S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322003
- Sponsor's protocol ID
- PL101-ALS301 / FNP254-CT-2501
- Acronym
- PREVAiLS
- Status last verified
- Jun 2026
- First submitted
- 5 Jan 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT07322003
- Acronym / sponsor ID
- PREVAiLS / PL101-ALS301 / FNP254-CT-2501
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- PrileniaIndustry (pharma, biotech, devices)
- Collaborators
- Ferrer Internacional S.A.
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 7 Jan 2026 (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.
The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:
Does pridopidine slow disease progression of ALS?
Researchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS.
Participants will:
Take pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks.
Visit the clinic once every 1-3 months for checkups and tests
Detailed description
This is a Phase 3, randomized study consisting of a double-blind placebo-controlled (DBPC) period followed by an open-label extension (OLE) to evaluate the efficacy and safety of pridopidine administered orally at a dose of 45 mg twice a day in adult participants with early and rapidly progressing ALS. Standard of care treatments (e.g. riluzole, edaravone and Nuedexta) will be allowed as long as participants are on a stable dose for at least 4 weeks prior to dosing. In the DBPC period, participants will be randomized in a 3:2 ratio to the pridopidine and placebo arms.
In the DBPC period, participants will receive pridopidine or placebo for 48 weeks. In the OLE period, all participants will receive pridopidine for 48 weeks, while maintaining the blind to their original randomization for both the participant as well as the Investigator and other clinical staff. The total study duration per participant will be 102 weeks including screening and follow up.
Throughout the study, participants will be assessed through on-site clinic visits and virtual visits (via telephone).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized (3:2), double-blind, placebo-controlled study followed by an open-label extension period. During the open-label extension, all participants will receive pridopidine.
| Arm | Type | Receives |
|---|---|---|
| Pridopidine | Experimental | Drug: PridopidinePridopidine hard gelatin capsules of 45 mg strength. During titration period 1 capsule taken orally in the morning for 2 weeks. During the main treatment period, 1 capsule in the morning and 1 capsule in the afternoon taken orally. Total daily dose of 90 mg. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo hard gelatin capsules. During titration period 1 capsule taken orally in the morning for 2 weeks. During the main treatment period, 1 capsule in the morning and 1 capsule in the afternoon taken orally. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Definite ALS or Probable ALS using the El Escorial criteria.
- Symptom onset of ≤18 months at screening.
- Slow vital capacity (SVC) greater or equal to 60% predicted.
- Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening.
- Able to swallow a capsule.
Key exclusion criteria (8 listed)
- Presence of tracheostomy or permanent assisted ventilation.
- Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.
- Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study.
- Clinically significant and/or unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and/or to study completion.
- Use of medications that prolong QT interval.
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 hard gelatin capsule. | Drug | Pridopidine |
| PlaceboPlacebo hard gelatin capsule. | Drug | Placebo |
Primary outcome
Change from baseline through Week 26 and Week 48 in the Revised ALS Functional Rating Scale (ALSFRS-R) total score adjusted for mortality
Time frame: Baseline to Week 48
The ALSFRS-R encompasses 12 questions grouped into 4 domains to assess bulbar symptoms, limb and trunk functionality, respiratory symptoms, and the need for percutaneous endoscopic gastrostomy (PEG), non-invasive ventilation, or tracheostomy with invasive ventilation. Each function is scored from 0 (no ability) to 4 (normal), with a minimum total score of 0 and maximum total score of 48. Higher scores indicate better functioning.
6 secondary outcomes
Overall survival at Week 96
Time frame: Baseline to Week 96
Change from baseline through Week 26 and Week 48 in speaking rate as measured by quantitative speech assessment in the clinic
Time frame: Baseline to Week 48
Change from baseline through Week 48 in intelligibility of speech by quantitative speech assessment in the clinic.
Time frame: Baseline to Week 48.
Change from baseline through Week 48 in percent predicted slow vital capacity (SVC)
Time frame: Baseline to Week 48
Change from baseline through Week 48 in the Bulbar subdomain of the ALSFRS-R
Time frame: Baseline to Week 48
Change from baseline through Week 48 in the Amyotrophic Lateral Sclerosis Assessment Questionnaire - 40 (ALSAQ-40)
Time frame: Baseline to Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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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.
55 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pridopidine in people with Amyotrophic Lateral Sclerosis, run by Prilenia at 55 sites in 13 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 8 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Italy, France, Germany, Spain and 8 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prilenia Medical Information (857-574-5755, MedInfo@prilenia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline through Week 26 and Week 48 in the Revised ALS Functional Rating Scale (ALSFRS-R) total score adjusted for mortality (time frame: Baseline to Week 48). It is what the study was designed to measure, not a finding.
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 6 Oct 2026.