Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
ConditionAmyotrophic Lateral Sclerosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPrilenia
About 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
Eligibility criteria
Qualifiers
Definite ALS or Probable ALS using the El Escorial criteria.
Symptom onset of ≤18 months at screening.
Slow vital capacity (SVC) greater or equal to 60% predicted.
Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening.
Disqualifiers
Presence of tracheostomy or permanent assisted ventilation.
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.
Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study.
Clinically significant and/or unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and/or to study completion.
Trial design
Treatments tested in this trial
- Pridopidine
- Placebo
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Prilenia
Lead sponsor
Ferrer Internacional S.A.
Collaborator
Source ClinicalTrials.gov