Pridopidine for ALS

(PREVAiLS Trial)

Recruiting at 4 trial locations

Overseen By Executive Director Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Prilenia

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

Definite ALS or Probable ALS using the El Escorial criteria

My symptoms began within the last 18 months.

Slow vital capacity (SVC) greater or equal to 60% predicted

Exclusion Criteria

Presence of tracheostomy or permanent assisted ventilation

I have serious heart disease or heart rhythm problems.

I do not have mental health or substance issues that prevent me from understanding or joining the study.

What Are the Treatments Tested in This Trial?

Interventions

• Pridopidine

How Is the Trial Designed?

Group I: Pridopidine Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Prilenia

Lead Sponsor

Trials

8

Recruited

1,500+

Ferrer Internacional S.A.

Industry Sponsor

Trials

27

Recruited

11,700+