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

Completed · Phase 2 · Has a placebo group

Conditions studied: Huntington's Disease

In brief

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).

Key facts

Study ID

NCT02006472

Run by

Prilenia

People needed

408

Starts

2014-02-28

Expected to finish

2016-07-07

Last updated by the study team

2021-07-19

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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 12199 — La Jolla, California, United States

Full record on ClinicalTrials.gov

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