Phase 2
N=37
Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease
Huntington's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01806896 ↗Enrolled (actual)
37
Serious AEs
5.6%
Results posted
Dec 2017
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) — 18; 14; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-02545920 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
18; 14; 1; 1 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern (Without Regard to Baseline Abnormality) |
8; 8 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Vital Signs Findings |
0; 0; 1; 0; 2; 1 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings |
1; 1; 0; 0; 2; 0 | — |
| PRIMARY Number of Participants With Change From Baseline in Body Weight of >=7% |
0; 0 | — |
| PRIMARY Categorical Summary of Participants Meeting Stopping Criteria |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Change From Baseline in Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score at Day 28 |
0.19; 0.90 | 0.68 |
| PRIMARY Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Baseline |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 7 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 28 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Functional Magnetic Resonance Imaging (fMRI) in Monetary Incentive Delay (MID) Task at Day 28 |
0.01; 0.11; -0.20; -0.05; 0.20; 0.45 | 0.79 |
| SECONDARY Change From Baseline in Grip Strength Incentive Motivation Task at Day 28: Percent of Maximum Voluntary Contraction (MVC) |
0.93; -6.37; 1.10; -6.47; 0.18; -7.10 | 0.04 sig |
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
Data sourced from ClinicalTrials.gov (NCT01806896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.