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Dopamine Stabilizer

Pridopidine for Amyotrophic Lateral Sclerosis

Phase 2 & 3
Waitlist Available
Led By Merit Cudkowicz, MD
Research Sponsored by Merit E. Cudkowicz, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 weeks

Summary

This trial is testing pridopidine, a drug, to see if it can help people with ALS. The study will check its safety and effectiveness. ALS patients are targeted because they have limited treatment options.

Eligible Conditions
  • ALS (Amyotrophic Lateral Sclerosis)
  • Amyotrophic Lateral Sclerosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Progression as Assessed by the ALSFRS-R Total Score
Mortality Event Rate
Secondary study objectives
Bulbar Function in All Randomized Participants
Bulbar Function in Participants With Rapid Pre-baseline Progression
Change in Bulbar Function in Participants With Bulbar Dysfunction at Baseline
+4 more

Side effects data

From 2022 Phase 2 & 3 trial • 163 Patients • NCT04615923
28%
Fall
24%
Muscular weakness
20%
Neuromyopathy
12%
Diarrhoea
12%
Constipation
12%
Nausea
11%
Dysphagia
10%
Fatigue
10%
COVID-19
8%
Dysarthria
8%
Salivary hypersecretion
8%
Dry mouth
7%
Contusion
7%
Dizziness
7%
Oedema peripheral
7%
Arthralgia
7%
Musculoskeletal pain
7%
Insomnia
7%
Anxiety
6%
Complication associated with device
6%
Dyspnoea
5%
Headache
5%
Depression
3%
Post lumbar puncture syndrome
3%
Muscle contractions involuntary
3%
Gastroesophageal reflux disease
2%
Amyotrophic lateral sclerosis
2%
Syncope
2%
Cognitive disorder
2%
Respiratory failure
2%
Atrial fibrillation
2%
Skin abrasion
2%
Pain in extremity
1%
COVID-19 pneumonia
1%
Cerebellar stroke
1%
Presyncope
1%
Hip fracture
1%
Ischaemic stroke
1%
Pulmonary embolism
1%
Pneumoperitoneum
1%
Failure to thrive
1%
Traumatic intracranial haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pridopidine
Matching Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PridopidineExperimental Treatment1 Intervention
Pridopidine is administered orally twice daily for 24 weeks.
Group II: Matching PlaceboPlacebo Group1 Intervention
Matching placebo is administered orally twice daily for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pridopidine
2020
Completed Phase 3
~580

Find a Location

Who is running the clinical trial?

Merit E. Cudkowicz, MDLead Sponsor
7 Previous Clinical Trials
2,691 Total Patients Enrolled
7 Trials studying Amyotrophic Lateral Sclerosis
2,691 Patients Enrolled for Amyotrophic Lateral Sclerosis
Prilenia TherapeuticsUNKNOWN
Merit Cudkowicz, MDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
2,508 Total Patients Enrolled
8 Trials studying Amyotrophic Lateral Sclerosis
2,508 Patients Enrolled for Amyotrophic Lateral Sclerosis
~33 spots leftby Dec 2025
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