Phase 3
Completed N=162
HEALEY ALS Platform Trial - Regimen D Pridopidine
Source: ClinicalTrials.gov NCT04615923 ↗Enrolled (actual)
162
Serious AEs
11.7%
Results posted
Aug 2023
Primary outcomePrimary: Disease Progression as Assessed by the ALSFRS-R Total Score — -0.99; -1.00 points per month
◆ Published Evidence
Emerging
18citations · ~18 / year
Pridopidine in Amyotrophic Lateral Sclerosis: The HEALEY ALS Platform Trial.
Summary
The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.
Regimen D will evaluate the safety and efficacy of a single study drug, pridopidine, in participants with ALS.
Linked Publications (2)
-
Pridopidine in Amyotrophic Lateral Sclerosis: The HEALEY ALS Platform Trial.
-
Pridopidine treatment in ALS: subgroup analyses from the HEALEY ALS Platform trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Progression as Assessed by the ALSFRS-R Total Score |
-0.99; -1.00 | — |
| PRIMARY Mortality Event Rate |
0.012; 0.012 | — |
| SECONDARY Change in Bulbar Function in Participants With Bulbar Dysfunction at Baseline |
-1.78; -1.69 | 0.78 |
| SECONDARY Bulbar Function in All Randomized Participants |
-1.16; -1.25 | 0.6594 |
| SECONDARY Respiratory Function |
-8.81; -8.35 | 0.7918 |
| SECONDARY Bulbar Function in Participants With Rapid Pre-baseline Progression |
-1.54; -1.54 | 0.9903 |
| SECONDARY Time to Bulbar Decline |
84; 66; 86; 77 | — |
| SECONDARY Muscle Strength |
-26.74; -24.97 | 0.5888 |
| SECONDARY Number of Participants That Experienced Death or Death Equivalent |
5; 6 | 0.9690 |
Eligibility Criteria
Inclusion Criteria
- No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683).
Exclusion Criteria
- The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).
- Participants with a confirmed prolonged Fridericia-corrected QT (QTcF) interval (defined as a QTcF interval of >450 ms for men and >470 ms for women).
- Participants with 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.
- Participants with known history of long QT syndrome or a first degree relative with this condition.
- Participants using prohibited medications within the 4 weeks prior to the Regimen Specific Screening Visit, as detailed in section 5.9.
- Participants using the following medications at the time of the Regimen Specific Screening Visit:
- Nuedexta - at a dosage higher than 20 mg dextromethorphan + 10 mg quinidine BID
- Citalopram - at a dosage higher than 20 mg/day
- Escitalopram - at a dosage higher than 10 mg/day
- Participants with a known allergy to any ingredient of the study intervention (pridopidine, silicified microcrystalline cellulose, and magnesium stearate).
Data sourced from ClinicalTrials.gov (NCT04615923) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.