Tests pridopidine against a placebo in amyotrophic lateral sclerosis
Tests whether pridopidine helps adults with amyotrophic lateral sclerosis, compared with a placebo.
Plain-language title generated from the registry record
Registry title: Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
Key facts
- Where
- Stockholm and Umeå, SwedenSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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
Read by machine on 9 November 2026.
Could this be for you?
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?
Source: NCT07322003, who can take part
Where in Sweden
- Studieenheten Akademiskt specialistcentrumStockholm, SwedenTaking people
- Umeå University HospitalUmeå, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Prilenia
- Trial code
- NCT07322003
- Record updated
- 27 October 2026
- Original description
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
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
Inclusion: 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.
Exclusion: 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.