A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Versus Placebo for Symptomatic Treatment in Patients With Huntington's Disease
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ClinicalTrials.gov Identifier: NCT02006472 |
Recruitment Status :
Completed
First Posted : December 10, 2013
Last Update Posted : March 7, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Huntington's Disease | Drug: Pridopidine Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 408 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily Versus Placebo for Symptomatic Treatment in Patients With Huntington's Disease |
Actual Study Start Date : | February 28, 2014 |
Actual Primary Completion Date : | July 31, 2016 |
Actual Study Completion Date : | August 31, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Pridopidine 45 mg
Twice daily
|
Drug: Pridopidine
22.5 mg and 45 mg capsules
Other Name: TV7820 Other: Placebo Capsules matching drug |
Experimental: Pridopidine 67.5 mg
Twice daily
|
Drug: Pridopidine
22.5 mg and 45 mg capsules
Other Name: TV7820 Other: Placebo Capsules matching drug |
Experimental: Pridopidine 90 mg
Twice daily
|
Drug: Pridopidine
22.5 mg and 45 mg capsules
Other Name: TV7820 Other: Placebo Capsules matching drug |
Experimental: Pridopidine 112.5 mg
Twice daily
|
Drug: Pridopidine
22.5 mg and 45 mg capsules
Other Name: TV7820 Other: Placebo Capsules matching drug |
Placebo Comparator: Placebo
Twice daily
|
Other: Placebo
Capsules matching drug |
- Change from baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at week 26 [ Time Frame: 26 weeks ]
- Change from Baseline in modified Physical Performance Test (mPPT) [ Time Frame: Baseline and Week 26 ]The mPPT quantifies the patient's performance in physical tasks. It is a standardized 9-item test that measures the patient's performance on functional tasks. Patients are given 2 chances to complete each of the 9 items, and assistive devices are permitted for the tasks that require a standing position (items 6 to 9). Both the speed and accuracy at which the patients complete the items are taken into account during scoring. The maximum score of the test is 36, with higher scores indicating better performance.
- Summary of participants with Adverse Events [ Time Frame: 66 weeks ]From signing of Informed Consent Form to the Follow-up Visit (Day 378)

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of HD based on the presence of >/= 36 CAG repeats
- Male or female age ≥21 years, with an onset of HD after 18 years' old.
- Females of child bearing potential have to be compliant in using adequate birth control throughout the duration of the study
- Body weight ≥50 kg
- Sum of >/= 25 points on the UHDRS-TMS and UHDRS Independence Score below 90%
- Able and willing to provide written informed consent prior to any study related procedure.
- Willing to provide a blood sample for genetic analyses
- Willing and able to take oral medication and able to comply with the study specific procedures.
- Ambulatory, being able to travel to the study centre, and judged by the investigator as likely to be able to continue to travel for the duration of the study.
-
Availability and willingness of a caregiver, informant or family member to accompany the patient to the clinic at study, and the suitability of the caregiver should be judged by the investigator.
- Other criteria apply, please contact the investigator for more information.
Exclusion Criteria:
- Patients with clinically significant heart disease at the screening visit
- Treatment with tetrabenazine within 6 weeks of study screening
- Patients with a history of epilepsy or of seizures within the last 5 years
- Have other serious medical illnesses in the opinion of the investigator may put the patient at risk when participating in the study or may influence the results of the study or affect the patient's ability to take part in the study
- Patients receiving medications (within the last 6 weeks prior to screening) that have been proven to prolong QT interval or who may require such medications during the course of the study such as but not limited to non allowed anti psychotic medications, tricyclic antidepressants and/or Class I antiarrhythmics
-
Patients receiving medications (within the last 6 weeks prior to screening) that are metabolized by CYP2D6 and have the potential of reducing seizure threshold
- Other criteria apply, please contact the investigator for more information

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02006472

Study Director: | Teva Medical Expert, MD | Teva Pharmaceuticals USA |
Responsible Party: | Prilenia |
ClinicalTrials.gov Identifier: | NCT02006472 |
Other Study ID Numbers: |
TV7820-CNS-20002 2013-001888-23 ( EudraCT Number ) |
First Posted: | December 10, 2013 Key Record Dates |
Last Update Posted: | March 7, 2019 |
Last Verified: | March 2019 |
Huntington's Disease Pridopidine Pride-HD |
Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Dementia Chorea Dyskinesias |
Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Cognition Disorders Neurocognitive Disorders Mental Disorders |