Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02006472




Registration number
NCT02006472
Ethics application status
Date submitted
5/12/2013
Date registered
10/12/2013
Date last updated
19/07/2021

Titles & IDs
Public title
A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease
Scientific 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
Secondary ID [1] 0 0
2013-001888-23
Secondary ID [2] 0 0
TV7820-CNS-20002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pridopidine
Other interventions - Placebo

Experimental: Pridopidine 45 mg - Twice daily

Experimental: Pridopidine 67.5 mg - Twice daily

Experimental: Pridopidine 90 mg - Twice daily

Experimental: Pridopidine 112.5 mg - Twice daily

Placebo comparator: Placebo - Twice daily


Treatment: Drugs: Pridopidine
22.5 mg and 45 mg capsules

Other interventions: Placebo
Capsules matching drug
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at Week 26
Timepoint [1] 0 0
26 weeks
Secondary outcome [1] 0 0
Number of Patients With Adverse Events
Timepoint [1] 0 0
52 weeks

Eligibility
Key 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.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/07/2016
Sample size
Target
Accrual to date
Final
408
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site 78055 - Caulfield South
Recruitment hospital [2] 0 0
Investigational Site 78056 - Kew
Recruitment hospital [3] 0 0
Investigational Site 78058 - Subiaco
Recruitment hospital [4] 0 0
Investigational Site 78057 - Westmead
Recruitment postcode(s) [1] 0 0
- Caulfield South
Recruitment postcode(s) [2] 0 0
- Kew
Recruitment postcode(s) [3] 0 0
- Subiaco
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Austria
State/province [13] 0 0
Innsbruck
Country [14] 0 0
Austria
State/province [14] 0 0
Wien
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Denmark
State/province [17] 0 0
Aarhus
Country [18] 0 0
Denmark
State/province [18] 0 0
Copenhagen
Country [19] 0 0
France
State/province [19] 0 0
Angers cedex 9
Country [20] 0 0
France
State/province [20] 0 0
Creteil
Country [21] 0 0
France
State/province [21] 0 0
Lille
Country [22] 0 0
France
State/province [22] 0 0
Marseille Cedex 5
Country [23] 0 0
France
State/province [23] 0 0
Salouel
Country [24] 0 0
France
State/province [24] 0 0
Toulouse
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Bochum
Country [27] 0 0
Germany
State/province [27] 0 0
Muenster
Country [28] 0 0
Germany
State/province [28] 0 0
Ulm
Country [29] 0 0
Italy
State/province [29] 0 0
Firenze
Country [30] 0 0
Italy
State/province [30] 0 0
Milano
Country [31] 0 0
Italy
State/province [31] 0 0
Napoli
Country [32] 0 0
Italy
State/province [32] 0 0
Pozzilli
Country [33] 0 0
Italy
State/province [33] 0 0
San Giovanni Rotondo
Country [34] 0 0
Netherlands
State/province [34] 0 0
Leiden
Country [35] 0 0
Poland
State/province [35] 0 0
Gdansk
Country [36] 0 0
Poland
State/province [36] 0 0
Krakow
Country [37] 0 0
Poland
State/province [37] 0 0
Poznan
Country [38] 0 0
Poland
State/province [38] 0 0
Warsaw
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Kazan
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Moscow
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Nizhny Novgorod
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Birmingham
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Cambridge
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Cardiff
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Headington
Country [46] 0 0
United Kingdom
State/province [46] 0 0
London
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Manchester
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Newcastle-Upon-Tyne
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Prilenia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
European Huntington's Disease Network
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Huntington Study Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02006472