Trial · NCT07322003
Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
NCT07322003, Phase 3, Recruiting, Prilenia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS. Trials, record NCT07322003. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07322003
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
- NCT number
- NCT07322003
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 500 participants, estimated
- Lead sponsor
- Prilenia
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Pridopidine, Placebo
- First posted
- 2026-01-07
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline through Week 26 and Week 48 in the Revised ALS Functional Rating Scale (ALSFRS-R) total score adjusted for mortality | 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. |
| Secondary | Overall survival at Week 96 | Baseline to Week 96 | Time to death in days from baseline as assessed at the end of open-label extension (OLE) period |
| Secondary | Change from baseline through Week 26 and Week 48 in speaking rate as measured by quantitative speech assessment in the clinic | Baseline to Week 48 | |
| Secondary | Change from baseline through Week 48 in intelligibility of speech by quantitative speech assessment in the clinic. | Baseline to Week 48. | |
| Secondary | Change from baseline through Week 48 in percent predicted slow vital capacity (SVC) | Baseline to Week 48 | 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. |
| Secondary | Change from baseline through Week 48 in the Bulbar subdomain of the ALSFRS-R | Baseline to Week 48 | Measures decline in bulbar function. |
| Secondary | Change from baseline through Week 48 in the Amyotrophic Lateral Sclerosis Assessment Questionnaire - 40 (ALSAQ-40) | Baseline to Week 48 | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07322003
GET https://conductscience.org/api/trials/v1/NCT07322003/registered