Sponsored by Pfizer Inc.
The Amaryllis study is a Phase II clinical research study of a PDE10 Inhibitor drug that may help neurons to communicate more effectively. The purpose of this research study is to compare the safety, tolerability and effectiveness of the investigational drug to placebo on improving voluntary movement and overall symptoms in individuals with HD.
Status
This study is currently recruiting participants
Formal Name
Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington’s Disease
Study Type
Interventional
Purpose
This study is a 26 week, randomized, parallel group, double blind comparison of PF-02545920 5 mg, PF-02545920 20 mg, and placebo dosed BID in the treatment of motor impairment of subjects with Huntington disease. A total of approximately 260 subjects are planned to be randomized in the study. Primary endpoint is the change from baseline in the Total Motor Score (TMS) assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 26 weeks of treatment. Secondary endpoints will include change from baseline in the Total Maximum Chorea (TMC) score of the UHDRS after 13 and 26 weeks of treatment and Clinical Global Impression-Improvement score after 13 and 26 weeks of treatment.
Canadian Locations and Contact Information:
British Columbia
Location: The University of British Columbia, Centre for Huntington Disease, Vancouver
Status: Not yet recruiting
Coordinator: to be announced
Phone: to be announced
Ontario
Location: Centre for Movement Disorders, Toronto
Status: No longer recruiting
Coordinator: Marijana Pajic
Phone: 416-847-7084
Quebec
Location: CHUM-Notre-Dame Hospital, Montreal
Status: Recruiting
Coordinator: Suzanne Paris
Phone: 514-890-8000 ext 26511
Exclusion Criteria (eligibility that would exclude you from this study)
- Clinically significant neurologic disorder other than Huntington disease;
- Other severe acute psychiatric conditions, mania and/or psychosis;
- History of neutropenia, and myeloproliferative disorders;
Source
ClinicalTrials.gov A service of the U.S. National Institutes of Health
ClinicalTrials.gov Identifier: NCT02197130
This study is currently recruiting participants.
Verified May 2015 by Pfizer
Information provided by (Responsible Party): Pfizer Inc.
For more detailed information on this study and others and for the most recent updates, please go to clinicaltrials.gov. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.