Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01806896
• Date of registration: 06/03/2013
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease
• Scientific 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
• Date of first enrolment: September 2013
• Target sample size: 37
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01806896
• 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

France

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Huntington's Disease

Intervention(s)

Drug: PF-02545920

Drug: Placebo

Primary Outcome(s)

Change From Baseline in Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score at Day 28 [Time Frame: Baseline, Day 28]

Number of Participants With Change From Baseline in Body Weight of >=7% [Time Frame: Baseline up to Day 38]

Number of Participants With Potentially Clinically Significant Vital Signs Findings [Time Frame: Baseline up to Day 38]

Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings [Time Frame: Baseline up to Day 38]

Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Baseline [Time Frame: Baseline (Day 1)]

Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 28 [Time Frame: Day 28]

Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 7 [Time Frame: Day 7]

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Time Frame: Baseline up to Day 38]

Categorical Summary of Participants Meeting Stopping Criteria [Time Frame: Baseline up to Day 38]

Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern (Without Regard to Baseline Abnormality) [Time Frame: Baseline up to Day 38]

Secondary Outcome(s)

Change From Baseline in Grip Strength Incentive Motivation Task at Day 28: Percent of Maximum Voluntary Contraction (MVC) [Time Frame: Baseline, Day 28]

Change From Baseline in Functional Magnetic Resonance Imaging (fMRI) in Monetary Incentive Delay (MID) Task at Day 28 [Time Frame: Baseline (Day 1), Day 28]

Secondary ID(s)

A8241016

2012-004432-31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/12/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01806896