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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
Must not have
Gene therapy at any time
Any serious medical condition or clinically significant laboratory, or vital sign abnormality that precludes the patient's safe participation in and completion of the study e.g. significant heart disease within 12 weeks before baseline or history of certain cardiac arrhythmias
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing a medication called pridopidine in people who have early stage Huntington Disease. The goal is to see if this medication can help manage their symptoms and slow down the disease. Patients who finish the main part of the study can continue taking the medication for a longer period. Pridopidine has been shown to be well-tolerated and may reduce motor impairment in patients with Huntington's 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.
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.
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
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never received gene therapy.
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I don't have any serious health issues that would make it unsafe for me to join the study.
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I have not had epilepsy or seizures in the last 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Huntington's Disease (HD) include VMAT2 inhibitors like tetrabenazine, deutetrabenazine, and valbenazine, which reduce chorea by depleting monoamines such as dopamine. This is crucial for HD patients as it helps manage involuntary movements. Pridopidine, a Sigma-1 Receptor Agonist, is being studied for its potential neuroprotective effects, which may help preserve neuronal function and slow disease progression. Additionally, neuroprotective agents like cannabigerol (CBG) have shown promise in reducing mutant huntingtin aggregation, potentially mitigating neurodegeneration. These mechanisms are vital as they address both symptomatic relief and underlying disease pathology, offering a comprehensive approach to HD management.
Neuroprotective properties of cannabigerol in Huntington's disease: studies in R6/2 mice and 3-nitropropionate-lesioned mice.

Find a Location

Who is running the clinical trial?

PrileniaLead Sponsor
6 Previous Clinical Trials
836 Total Patients Enrolled
~100 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
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