A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease
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
2 other identifiers
interventional
408
11 countries
56
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2014
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2013
CompletedFirst Posted
Study publicly available on registry
December 10, 2013
CompletedStudy Start
First participant enrolled
February 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2016
CompletedResults Posted
Study results publicly available
July 19, 2021
CompletedJuly 19, 2021
May 1, 2021
1.8 years
December 5, 2013
March 14, 2021
July 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at Week 26
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.
26 weeks
Secondary Outcomes (1)
Number of Patients With Adverse Events
52 weeks
Other Outcomes (1)
Change From Baseline in Total Functional Capacity (TFC) at Week 52
52 weeks
Study Arms (5)
Pridopidine 45 mg
EXPERIMENTALTwice daily
Pridopidine 67.5 mg
EXPERIMENTALTwice daily
Pridopidine 90 mg
EXPERIMENTALTwice daily
Pridopidine 112.5 mg
EXPERIMENTALTwice daily
Placebo
PLACEBO COMPARATORTwice daily
Interventions
22.5 mg and 45 mg capsules
Capsules matching drug
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prilenialead
- European Huntington's Disease Networkcollaborator
- Huntington Study Groupcollaborator
Study Sites (58)
Investigational Site 12199
La Jolla, California, United States
Investigational Site 12204
Los Angeles, California, United States
Investigational Site 12201
Englewood, Colorado, United States
Investigational Site 12196
Washington D.C., District of Columbia, United States
Investigational Site 12207
Chicago, Illinois, United States
Investigational Site 12202
Baltimore, Maryland, United States
Investigational Site 12206
Baltimore, Maryland, United States
Investigational Site 12200
Manhasset, New York, United States
Investigational Site 12203
New York, New York, United States
Investigational Site 12198
Rochester, New York, United States
Investigational Site 12211
Winston-Salem, North Carolina, United States
Investigational Site 12205
Cincinnati, Ohio, United States
Investigational Site 12209
Pittsburgh, Pennsylvania, United States
Investigational Site 12208
Salt Lake City, Utah, United States
Investigational Site 12210
Richmond, Virginia, United States
Investigational Site 12197
Kirkland, Washington, United States
Investigational Site 78055
Caulfield South, Australia
Investigational Site 78056
Kew, Australia
Investigational Site 78058
Subiaco, Australia
Investigational Site 78057
Westmead, Australia
Investigational Site 33021
Innsbruck, Austria
Investigational Site 33027
Vienna, Austria
Investigational Site 11035
Vancouver, British Columbia, Canada
Investigational Site 11037
Ottawa, Ontario, Canada
Investigational Site 11036
Toronto, Ontario, Canada
Investigational Site 39028
Aarhus, Denmark
Investigational Site 39027
Copenhagen, Denmark
Investigational Site 35123
Angers, France
Investigational Site 35122
Créteil, France
Investigational Site 35125
Lille, France
Investigational Site 35124
Marseille, France
Investigational Site 35121
Salouël, France
Investigational Site 35165
Toulouse, France
Investigational Site 32408
Berlin, Germany
Investigational Site 32410
Bochum, Germany
Investigational Site 32409
Münster, Germany
Investigational Site 32407
Ulm, Germany
Investigational Site 30083
Florence, Italy
Investigational Site 30080
Milan, Italy
Investigational Site 30082
Napoli, Italy
Investigational Site 30081
Pozzilli, Italy
Investigational Site 30084
San Giovanni Rotondo, Italy
Investigational Site 38059
Leiden, Netherlands
Investigational Site 53150
Gdansk, Poland
Investigational Site 53149
Krakow, Poland
Investigational Site 53148
Poznan, Poland
Investigational Site 53151
Warsaw, Poland
Investigational Site 50215
Kazan', Russia
Investigational Site 50213
Moscow, Russia
Investigational Site 50214
Nizhny Novgorod, Russia
Investigational Site 34058
Birmingham, United Kingdom
Investigational Site 34054
Cambridge, United Kingdom
Investigational Site 34059
Cardiff, United Kingdom
Investigational Site 34056
Headington, United Kingdom
Investigational Site 34060
London, United Kingdom
Investigational Site 34055
Manchester, United Kingdom
Investigational Site 34061
Newcastle upon Tyne, United Kingdom
Investigational Site 34057
Sheffield, United Kingdom
Related Publications (4)
McGarry A, Leinonen M, Kieburtz K, Geva M, Olanow CW, Hayden M. Effects of Pridopidine on Functional Capacity in Early-Stage Participants from the PRIDE-HD Study. J Huntingtons Dis. 2020;9(4):371-380. doi: 10.3233/JHD-200440.
PMID: 33164941BACKGROUNDDarpo B, Geva M, Ferber G, Goldberg YP, Cruz-Herranz A, Mehra M, Kovacs R, Hayden MR. Pridopidine Does Not Significantly Prolong the QTc Interval at the Clinically Relevant Therapeutic Dose. Neurol Ther. 2023 Apr;12(2):597-617. doi: 10.1007/s40120-023-00449-w. Epub 2023 Feb 22.
PMID: 36811812DERIVEDRodrigues FB, Quinn L, Wild EJ. Huntington's Disease Clinical Trials Corner: January 2019. J Huntingtons Dis. 2019;8(1):115-125. doi: 10.3233/JHD-190001.
PMID: 30776019DERIVEDReilmann R, McGarry A, Grachev ID, Savola JM, Borowsky B, Eyal E, Gross N, Langbehn D, Schubert R, Wickenberg AT, Papapetropoulos S, Hayden M, Squitieri F, Kieburtz K, Landwehrmeyer GB; European Huntington's Disease Network; Huntington Study Group investigators. Safety and efficacy of pridopidine in patients with Huntington's disease (PRIDE-HD): a phase 2, randomised, placebo-controlled, multicentre, dose-ranging study. Lancet Neurol. 2019 Feb;18(2):165-176. doi: 10.1016/S1474-4422(18)30391-0. Epub 2018 Dec 15.
PMID: 30563778DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Analyses for Early HD population were conducted as additional analyses
Results Point of Contact
- Title
- Prilenia
- Organization
- Prilenia
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2013
First Posted
December 10, 2013
Study Start
February 28, 2014
Primary Completion
December 16, 2015
Study Completion
July 7, 2016
Last Updated
July 19, 2021
Results First Posted
July 19, 2021
Record last verified: 2021-05