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A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02006472
Recruitment Status : Completed
First Posted : December 10, 2013
Results First Posted : July 19, 2021
Last Update Posted : July 19, 2021
Sponsor:
Collaborators:
European Huntington's Disease Network
Huntington Study Group
Information provided by (Responsible Party):
Prilenia

Study Description
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Brief Summary:
This is a multicenter, multinational, randomized, parallel-group, double-blind, placebo-controlled, dose range finding study to compare the efficacy and safety of different doses of pridopidine versus placebo in the treatment of motor impairment in Huntington's Disease (HD).

Condition or disease Intervention/treatment Phase
Huntington's Disease Drug: Pridopidine Other: Placebo Phase 2

Detailed Description:
Originally, the study was designed to assess the effect of pridopidine on motor function at 26 weeks. Due to the recognition that the primary target of pridopidine is the Sigma-1 receptor, the trial was extended from 26 to 52 weeks to evaluate the effect of pridopidine on Total Functional Capacity (TFC). A minimum of 52 weeks are needed for the placebo group to decline and allow a window to assess an effect on TFC (a prespecified endpoint). Approximately 20% of patients completed 26 weeks of the study before IRB approvals for this extension, and did not continue into the 2nd treatment period up to 52 weeks.
Study Design
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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, 67.5, 90, and 112.5 mg Twice-Daily vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease
Actual Study Start Date : February 28, 2014
Actual Primary Completion Date : December 16, 2015
Actual Study Completion Date : July 7, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at Week 26 [ Time Frame: 26 weeks ]
    TMS was defined as the sum of all UHDRS motor domains ratings. The motor section of the UHDRS assesses motor features of Huntington's Disease (HD) with standardized ratings of oculo-motor function, dysarthria, chorea, dystonia, gait, and postural stability. Each of 15 assessments is rated on a scale of 0 (normal) to 4 (marked impairment) for a TMS range of 0-124. Negative change from baseline values indicate improvement.


Secondary Outcome Measures :
  1. Number of Patients With Adverse Events [ Time Frame: 52 weeks ]

Other Outcome Measures:
  1. Change From Baseline in Total Functional Capacity (TFC) at Week 52 [ Time Frame: 52 weeks ]
    The TFC is one subscale of the Unified Huntington's Disease Rating Scale (UHDRS), comprising 5 functional domains associated with disability (occupation, finances, domestic chores, activities of daily living, and care level), with scores on each item ranging from 0 to either 2 or 3. The TFC total score is the sum of the 5 TFC items and can range from 0 to 13, with greater scores indicating higher functioning. Negative change from baseline indicates worsening.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 childbearing potential must 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 <=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 center, 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

    • Other criteria apply, please contact the investigator for more information
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
Show Show 58 study locations
Sponsors and Collaborators
Prilenia
European Huntington's Disease Network
Huntington Study Group
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Results First Posted: July 19, 2021
Last Update Posted: July 19, 2021
Last Verified: May 2021
Keywords provided by Prilenia:
Huntington's Disease
Pridopidine
Pride-HD
Additional relevant MeSH terms:
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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