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

This study has been completed.
Sponsor:
Collaborators:
European Huntington's Disease Network
Huntington Study Group
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT02006472
First received: December 5, 2013
Last updated: September 9, 2016
Last verified: September 2016
  Purpose
This is a multicenter, multinational, randomized, parallel-group, double-blind, placebo-controlled, does 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 Intervention Phase
Huntington's Disease Drug: Pridopidine Other: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):

Primary Outcome Measures:
  • Change from baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at week 26 [ Time Frame: 26 weeks ]

Secondary Outcome Measures:
  • 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)


Enrollment: 408
Study Start Date: February 2014
Study Completion Date: August 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006472

  Hide Study Locations
Locations
United States, California
Teva Investigational Site 12199
La Jolla, California, United States
Teva Investigational Site 12204
Los Angeles, California, United States
United States, Colorado
Teva Investigational Site 12201
Englewood, Colorado, United States
United States, District of Columbia
Teva Investigational Site 12196
Washington, District of Columbia, United States
United States, Illinois
Teva Investigational Site 12207
Chicago, Illinois, United States
United States, Maryland
Teva Investigational Site 12202
Baltimore, Maryland, United States
Teva Investigational Site 12206
Baltimore, Maryland, United States
United States, New York
Teva Investigational Site 12200
Manhasset, New York, United States
Teva Investigational Site 12203
New York, New York, United States
Teva Investigational Site 12198
Rochester, New York, United States
United States, North Carolina
Teva Investigational Site 12211
Winston-Salem, North Carolina, United States
United States, Ohio
Teva Investigational Site 12205
Cincinnati, Ohio, United States
United States, Pennsylvania
Teva Investigational Site 12209
Pittsburgh, Pennsylvania, United States
United States, Utah
Teva Investigational Site 12208
Salt Lake City, Utah, United States
United States, Virginia
Teva Investigational Site 12210
Richmond, Virginia, United States
United States, Washington
Teva Investigational Site 12197
Kirkland, Washington, United States
Australia
Teva Investigational Site 78056
Kew, Australia
Teva Investigational Site 78055
South Caulfield, Australia
Teva Investigational Site 78058
Subiaco, Australia
Teva Investigational Site 78057
Westmead, Australia
Austria
Teva Investigational Site 33021
Innsbruck, Austria
Teva Investigational Site 33027
Wien, Austria
Canada, British Columbia
Teva Investigational Site 11035
Vancouver, British Columbia, Canada
Canada, Ontario
Teva Investigational Site 11037
Ottawa, Ontario, Canada
Teva Investigational Site 11036
Toronto, Ontario, Canada
Denmark
Teva Investigational Site 39028
Aarhus, Denmark
Teva Investigational Site 39027
Copenhagen, Denmark
France
Teva Investigational Site 35123
Angers cedex 9, France
Teva Investigational Site 35122
Creteil, France
Teva Investigational Site 35125
Lille, France
Teva Investigational Site 35124
Marseille Cedex 5, France
Teva Investigational Site 35121
Salouel, France
Teva Investigational Site 35165
Toulouse, France
Germany
Teva Investigational Site 32408
Berlin, Germany
Teva Investigational Site 32410
Bochum, Germany
Teva Investigational Site 32409
Muenster, Germany
Teva Investigational Site 32407
Ulm, Germany
Italy
Teva Investigational Site 30083
Firenze, Italy
Teva Investigational Site 30080
Milano, Italy
Teva Investigational Site 30082
Napoli, Italy
Teva Investigational Site 30081
Pozzilli (IS), Italy
Teva Investigational Site 30084
San Giovanni Rotondo (FG), Italy
Netherlands
Teva Investigational Site 38059
Leiden, Netherlands
Poland
Teva Investigational Site 53150
Gdansk-Zaspa, Poland
Teva Investigational Site 53149
Krakow, Poland
Teva Investigational Site 53148
Poznan, Poland
Teva Investigational Site 53151
Warsaw, Poland
Russian Federation
Teva Investigational Site 50215
Kazan, Russian Federation
Teva Investigational Site 50213
Moscow, Russian Federation
Teva Investigational Site 50214
Nizhny Novgorod, Russian Federation
United Kingdom
Teva Investigational Site 34058
Birmingham, United Kingdom
Teva Investigational Site 34054
Cambridge, United Kingdom
Teva Investigational Site 34059
Cardiff, United Kingdom
Teva Investigational Site 34056
Headington, United Kingdom
Teva Investigational Site 34060
London, United Kingdom
Teva Investigational Site 34055
Manchester, United Kingdom
Teva Investigational Site 34061
Newcastle-Upon-Tyne, United Kingdom
Teva Investigational Site 34057
Sheffield, United Kingdom
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
European Huntington's Disease Network
Huntington Study Group
Investigators
Study Director: Teva Medical Expert, MD TEVA
  More Information

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT02006472     History of Changes
Other Study ID Numbers: TV7820-CNS-20002
2013-001888-23 ( EudraCT Number )
Study First Received: December 5, 2013
Last Updated: September 9, 2016

Keywords provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):
Huntington's Disease
Pridopidine
Pride-HD

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 18, 2017