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NCT07322003 · ClinicalTrials.gov registry record · Phase 3
Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
A Phase 3 study of Amyotrophic Lateral Sclerosis, sponsored by Prilenia.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 3
- Study locations
NCT07322003: Recruiting Phase 3 study of Amyotrophic Lateral Sclerosis, sponsored by Prilenia.
NCT07322003 is a Phase 3 study of Amyotrophic Lateral Sclerosis that is actively recruiting participants, run by Prilenia. The registered enrollment target is 500 participants, below the 893-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (44% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07322003, a Phase 3 study of Amyotrophic Lateral Sclerosis, is actively recruiting participants, sponsored by Prilenia.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 3
- Study locations
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
Primary Outcome
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.
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 |
What NCT07322003 shows while recruiting
NCT07322003 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 893-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (44% lower).
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.
NCT07322003 reports a single indexed study location in Massachusetts, Nebraska, Texas.
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.
What interventions are being tested in trial NCT07322003?
The interventions under investigation include: Placebo (DRUG), Pridopidine (DRUG).
Who is sponsoring clinical trial NCT07322003?
This trial is sponsored by Prilenia, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07322003's enrollment target sits among peer trials
500 21st of 102 higher than 81 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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