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Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
NCT07322003 · View on ClinicalTrials.gov ↗
Study 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. 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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pridopidine
Study Locations (3)
Massachusetts
- Sean M. Healey & AMG Center for ALS — Boston
Nebraska
- Somnos Clinical Research — Lincoln
Texas
- Texas Neurology — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2026-02-01 |
| Est. Completion | 2029-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07322003
The ClinicalTrials.gov registry entry for NCT07322003 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prilenia, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07322003 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Massachusetts, Nebraska, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07322003 about?
NCT07322003 is a clinical study titled "Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS". 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...
What is the current status of trial NCT07322003?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2026-02-01. Estimated completion is 2029-03.
What conditions does trial NCT07322003 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07322003?
The interventions under investigation include: Placebo (DRUG), Pridopidine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07322003?
This trial is sponsored by Prilenia, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07322003 being conducted?
This trial has 3 study locations across Massachusetts, Nebraska, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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