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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 July 2021
• Main ID: NCT02006472
• Date of registration: 05/12/2013
• Prospective Registration: Yes
• Primary sponsor: Prilenia
• 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
• Date of first enrolment: February 28, 2014
• Target sample size: 408
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02006472
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Austria, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Russian Federation, United Kingdom, United States

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Huntington's Disease

Intervention(s)

Drug: Pridopidine

Other: Placebo

Primary Outcome(s)

Change From Baseline in Unified Huntington's Disease Rating Scale-Total Motor Score (UHDRS-TMS) at Week 26 [Time Frame: 26 weeks]

Secondary Outcome(s)

Number of Patients With Adverse Events [Time Frame: 52 weeks]

Secondary ID(s)

2013-001888-23

TV7820-CNS-20002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Huntington Study Group

European Huntington's Disease Network

Results

• Results available: Yes
• Date Posted: 19/07/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02006472