Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Conditions

• Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Pridopidine — DRUG
  Pridopidine hard gelatin capsule.
• Placebo — DRUG
  Placebo hard gelatin capsule.

Study Details

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

Key Dates

Start date

Feb 1, 2026

Status verified

Jun 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2029

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pridopidine
  Pridopidine hard gelatin capsules of 45 mg strength. During titration period 1 capsule taken orally in the morning for 2 weeks. During the main treatment period, 1 capsule in the morning and 1 capsule in the afternoon taken orally. Total daily dose of 90 mg.
• Placebo Comparator: Placebo
  Placebo hard gelatin capsules. During titration period 1 capsule taken orally in the morning for 2 weeks. During the main treatment period, 1 capsule in the morning and 1 capsule in the afternoon taken orally.

Primary Outcome Measure

Change from baseline through Week 26 and Week 48 in the Revised ALS Functional Rating Scale (ALSFRS-R) total score adjusted for mortality [ Time Frame: Baseline to Week 48 ]

Central Contacts

• Executive Director Clinical Operations
  857-574-5755
  [email protected]

Locations (9)

Find similar trials in Florida City, FL

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