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Taking people in FrancePhase 3

Tests pridopidine against a placebo in amyotrophic lateral sclerosis

Tests whether pridopidine helps adults with amyotrophic lateral sclerosis, compared with a placebo.

Key facts

Who runs it
Prilenia
Where
Lille, Marseille, Nice, Paris, and Tours, FranceSee the 5 sitesAlso in 12 other countries, 51 sites
Trial code
Registry title
Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
Status
Recruiting
Phase
Phase 3
People taking part
500 people, planned
Started
1 Feb 2026
Expected to end
Mar 2029
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Pridopidine
  • Placebo
Record updated
27 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with definite or probable ALS whose symptoms began 18 months ago or less. It tests whether pridopidine slows the disease.

Age
18 to 80 years
Sex
Men and women can both join.
Disease stage
Definite or probable ALS (El Escorial criteria); symptoms started 18 months ago or less; slow vital capacity of 60% predicted or more; TRICALS Risk Profile Calculator score from -6 to -2.
Earlier treatment
People cannot have had pridopidine, gene therapy or antisense oligonucleotides before.
Biomarker or test result
People with a confirmed mutation in the SOD1, FUS or C9orf72 gene cannot join.

Main reasons for not taking part

  • Tracheostomy or permanent assisted ventilation
  • Significant heart disease, arrhythmia or left bundle branch block
  • Unstable psychiatric disease, cognitive impairment, dementia or substance abuse
  • Use of medications that prolong QT interval
  • Pregnancy

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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 take part

  • Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides
  • 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
  • Presence of tracheostomy or permanent assisted ventilation
  • Confirmed mutation in the SOD1, FUS or C9orf72 gene
  • Pregnancy

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in France

Also in 12 other countries, 51 sites

  • CHU LilleLille, FranceTaking people
  • Hôpitaux Universitaires de Marseille TimoneMarseille, FranceTaking people
  • Centre Hospitalier Universitaire de NiceNice, FranceContact: Dr. SorianiTaking people
  • Hospitalier Pitie-SalpetriereParis, FranceTaking people
  • Centre hospitalier régional universitaire de de ToursTours, FranceTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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

The 2 groups in the trial

  • PridopidineTreatment being tested

    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.

  • PlaceboPlacebo, for comparison

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Tests pridopidine against a placebo in amyotrophic lateral sclerosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07322003, who can take part
Record updated
27 October 2026