Clinical trial NCT01806896: Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Huntington's Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-03-07
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the Safety, Tolerability and Brain Function of 2 doses of PF-0254920 in Subjects with Early Huntington's Disease.


Eligibility criteria: Inclusion Criteria:

* Must have a diagnosis of Huntington's Disease
* a CAG repeat expansion equal or great than 39
* a Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score equal or greater than 5 and less than 60
* a UHDRS Total Functional Capacity equal or greater than 9

Exclusion Criteria:

* Subjects with evidence or history of severe acute or chronic medical condition or laboratory abnormality, or significant neurological disorder other than HD.
* Treatment with any antipsychotic medication within 5 weeks of enrollment

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 38
measure: Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern (Without Regard to Baseline Abnormality)
timeFrame: Baseline up to Day 38
measure: Number of Participants With Potentially Clinically Significant Vital Signs Findings
timeFrame: Baseline up to Day 38
measure: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
timeFrame: Baseline up to Day 38
measure: Number of Participants With Change From Baseline in Body Weight of >=7%
timeFrame: Baseline up to Day 38
measure: Categorical Summary of Participants Meeting Stopping Criteria
timeFrame: Baseline up to Day 38
measure: Change From Baseline in Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score at Day 28
timeFrame: Baseline, Day 28
measure: Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Baseline
timeFrame: Baseline (Day 1)
measure: Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 7
timeFrame: Day 7
measure: Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 28
timeFrame: Day 28
Secondary outcomes:
measure: Change From Baseline in Functional Magnetic Resonance Imaging (fMRI) in Monetary Incentive Delay (MID) Task at Day 28
timeFrame: Baseline (Day 1), Day 28
measure: Change From Baseline in Grip Strength Incentive Motivation Task at Day 28: Percent of Maximum Voluntary Contraction (MVC)
timeFrame: Baseline, Day 28
Other outcomes:
Locations:
city: Paris Cedex 13
country: France
facility: Centre d'Investigation Clinique (CIC)/ Institut du Cerveau et de la Möelle Epinière (ICM)
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: