Study Evaluating the Safety, Tolerability and Brain Function of 2 Doses of PF-0254920 in Subjects With Early Huntington's Disease.
This study will evaluate the Safety, Tolerability and Brain Function of 2 doses of PF-0254920 in Subjects with Early Huntington's Disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2, Double-blind Randomized, Sequential Treatment Group, Placebo-controlled Study to Evaluate the Safety, Tolerability and Brain Cortico-striatal Function of 2 Doses of PF-02545920 in Subjects With Early Huntington's Disease.|
- Change from Baseline to Day 28 of Unified Huntington Disease Rating Scale -Total Motor Score (TMS) [ Time Frame: Screening, Day 1, Day 28 ] [ Designated as safety issue: Yes ]The UHDRS is a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of HD. the Total Motor Score (TMS) is one of the six sub components of UHDRS.
- Change from Baseline to Day28 in fMRI parameter estimates and percent signal change during Monetary Incentive Delay [ Time Frame: Baseline, Day28 ] [ Designated as safety issue: No ]The monetary incentive delay (MID) task is established as a reliable method to elicit ventral striatal activity in relation to reward/punishment anticipation and tracked with dysfunctionalities across a range of conditions in which incentive motivation is thought to be abnormal (schizophrenia, depression, substance abuse, and pathological gambling). Pharmacological intervention has demonstrated reversal of observed deficit.
- Change from Baseline to Day28 in Grip Strength Incentive Motivation task score [ Time Frame: Baseline predose, Baseline postdose, Day28 ] [ Designated as safety issue: No ]This incentive force task was developed to independently dissociate the degree to which a subject responds to reward motivation versus emotional motivation, as well as a subject's perception of difficulty level in performing a given task.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
|Experimental: 20 mg Arm Cohort A||
|Placebo Comparator: Placebo Arm Cohort A||
- Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
Dosing for 28 days.
|Experimental: 5 mg Arm Cohort B||
|Placebo Comparator: Placebo Arm Cohort B||
|Contact: Pfizer CT.gov Call Center||1-800-718-1021|
|Pfizer Investigational Site||Recruiting|
|Paris, France, 75013|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|