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Tests treatment safety and results for Amyotrophic Lateral Sclerosis
Official title Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
ClinicalTrials.gov ID: NCT07322003
What this study is testing
What is Pridopidine?
Pridopidine is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for amyotrophic lateral sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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)...
- Able to swallow a capsule. Key
You likely can't join if
- Presence of tracheostomy or permanent assisted ventilation.
- Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite...
- Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide...
- Clinically significant and/or unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and/or...
- Use of medications that prolong QT interval.
- Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.
See the full eligibility criteria
- 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.
- Able to swallow a capsule. Key
- 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...
- 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.
- Use of medications that prolong QT interval.
- Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.
- Confirmed mutation in the SOD1, FUS or C9orf72 gene.
- Pregnancy.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Fairway, Kansas, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Lincoln, Nebraska, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Leuven, Belgium
- Montreal, Quebec, Canada
- Paris, France
- Berlin, Germany
- Bonn, Germany
- Jena, Germany
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Jacksonville, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Fairway, Kansas, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.