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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
No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 weeks
Awards & highlights

Study Summary

This trial is testing a drug called pridopidine to see if it is safe and effective in treating people with ALS.

Eligible Conditions
  • ALS (Amyotrophic Lateral Sclerosis)

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease Progression as Assessed by the ALSFRS-R Total Score
Mortality Event Rate
Secondary outcome measures
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%
Constipation
12%
Diarrhoea
12%
Nausea
11%
Dysphagia
10%
COVID-19
10%
Fatigue
8%
Dysarthria
8%
Salivary hypersecretion
8%
Dry mouth
7%
Dizziness
7%
Contusion
7%
Oedema peripheral
7%
Arthralgia
7%
Anxiety
7%
Insomnia
7%
Musculoskeletal pain
6%
Complication associated with device
6%
Dyspnoea
5%
Depression
5%
Headache
3%
Muscle contractions involuntary
3%
Gastroesophageal reflux disease
3%
Post lumbar puncture syndrome
2%
Syncope
2%
Respiratory failure
2%
Atrial fibrillation
2%
Pain in extremity
2%
Amyotrophic lateral sclerosis
2%
Cognitive disorder
2%
Skin abrasion
1%
Failure to thrive
1%
Traumatic intracranial haemorrhage
1%
COVID-19 pneumonia
1%
Cerebellar stroke
1%
Ischaemic stroke
1%
Presyncope
1%
Pulmonary embolism
1%
Hip fracture
1%
Pneumoperitoneum
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pridopidine been used in other scientific research projects before?

"There are currently 3 clinical trials for Pridopidine with 1 being in Phase 3. With the majority of the research taking place in Boston, Massachusetts, there are a total of 127 locations running trials for Pridopidine."

Answered by AI

Is this research project enrolling new participants at this time?

"This particular trial is not currently seeking patients. The original posting was on December 18th, 2020 and the most recent update was on September 18th, 2022. There are, however, 135 other clinical trials for amyotrophic lateral sclerosis and 3 for Pridopidine that are actively recruiting participants."

Answered by AI

How many human subjects are involved in this clinical trial?

"Enrollment for this study has been paused; it was originally posted on December 18th, 2020. The last update to the study was on September 18th, 2022. There are presently 135 studies actively recruiting patients with amyotrophic lateral sclerosis and 3 trials for Pridopidine searching for eligible participants."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Healey Center for ALS at Mass General
What portion of applicants met pre-screening criteria?
Met criteria
~38 spots leftby Mar 2025