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Pridopidine for Huntington's Disease

Phase 3
Waitlist Available
Research Sponsored by Prilenia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of HD based on clinical features and the presence of ≥36 CAG repeats in the huntingtin gene
Stage 1 or Stage 2 HD, defined as a UHDRS-TFC score of ≥7, at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 65 weeks
Awards & highlights

Study Summary

This trial will study whether pridopidine is an effective and safe treatment for early stage Huntington Disease.

Who is the study for?
This trial is for adults with early stage Huntington's Disease, specifically stages 1 or 2, as indicated by a UHDRS-TFC score of ≥7. Participants must have a confirmed diagnosis with ≥36 CAG repeats in the huntingtin gene and onset of symptoms at age 18 or older. Those who've had gene therapy, used pridopidine within the last year, have serious medical conditions like recent heart disease or seizures in the past five years, or are pregnant can't join.Check my eligibility
What is being tested?
The study tests if pridopidine (45mg twice daily) is effective and safe for patients with early stage Huntington's Disease compared to a placebo. Patients will be randomly assigned to receive either pridopidine or an inactive substance without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed here, common side effects from similar medications may include nausea, fatigue, dizziness, and mood changes. The safety profile of pridopidine will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Huntington's disease based on genetic testing.
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My condition is in the early stages, with a functional score of 7 or higher.
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My Huntington's disease symptoms started when I was 18 or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 65 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 65 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
Change from baseline in the Unified Huntington Disease Rating Scale-Total functional capacity (UHDRS-TFC) score

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%
Dry mouth
8%
Dysarthria
8%
Salivary hypersecretion
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%
Presyncope
1%
Traumatic intracranial haemorrhage
1%
COVID-19 pneumonia
1%
Cerebellar stroke
1%
Ischaemic stroke
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
45 mg pridopidine twice daily (BID)
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo
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?

PrileniaLead Sponsor
6 Previous Clinical Trials
836 Total Patients Enrolled

Frequently Asked Questions

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

Are we able to enroll new patients in this research project at this time?

"From what is published on clinicaltrials.gov, it appears that recruitment for this particular study has concluded. The trial was initially posted on October 16th 2020 and last updated on November 18th 2021. With that being said, there are 40 other active studies that are still recruiting patients."

Answered by AI

Is Pridopidine known to cause serious side effects in patients?

"Since this is a Phase 3 trial, meaning that there is both anecdotal evidence and multiple rounds of safety testing, our team at Power has given Pridopidine a score of 3 for safety."

Answered by AI

Are there any other ongoing research projects involving Pridopidine at this time?

"Pridopidine is currently being studied in 3 different trials, with 3 of those trials being in the final stage of testing. Although the majority of the clinical trials for Pridopidine are based in Seattle, 127 different locations across the globe are running tests."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
Colorado
How old are they?
18 - 65
What site did they apply to?
Prilenia Investigational Site (Site 051)
Prilenia Investigational Site (Site 343)
Prilenia Investigational Site (Site 380)
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD
2020. "PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04556656.
All > Huntington Disease
~111 spots leftby Apr 2025
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