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Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02197130
First received: July 16, 2014
Last updated: October 12, 2016
Last verified: October 2016
  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's 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.

Condition Intervention Phase
Huntington's Disease Drug: PF-02545920 Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Placebo Controlled, Double Blind Proof-of-concept Study Of The Efficacy And Safety Of Pf-02545920 In Subjects With Huntington's Disease

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in UHDRS Total Motor Score (TMS) after 26 weeks of treatment [ Time Frame: 26 week ]
    UHDRS TMS


Secondary Outcome Measures:
  • White blood count and absolute neutrophil count [ Time Frame: Baseline to Follow-up visit (Day 189) ]
    Monitoring of ANC and WBC

  • Extrapyramidal symptoms [ Time Frame: Baseline to Follow-up visit (Day 189) ]
    Occurence of dystonia or akathisia

  • Change from baseline in the Total Maximum Chorea (TMC) score of the UHDRS after 13 and 26 weeks of treatment [ Time Frame: 13 and 26 wks ]
    UHDRS TMC

  • Clinical Global Impression-Improvement score after 13 and 26 weeks of treatment. [ Time Frame: 13 and 26 weeks ]
    CGI

  • Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline to Follow-up Visit (Day 189) ]
    C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").


Enrollment: 272
Study Start Date: September 2014
Study Completion Date: October 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 20 mg PF-02545920 BID
20 mg PF-02545920 BID
Drug: PF-02545920
20 mg twice a day (BID) for 26 weeks. Each 20 mg dose will be taken as 4 tablets of 5 mg. The 20mg dose will be titrated as follow: 5mg BID for 7 days, 10mg BID for 7 days, 15 mg BID for 7 days and 20 mg BID to week 26. Study drug will be provided in weekly blister cards.
Experimental: 5 mg PF-02545920 BID
5 mg PF-02545920 BID
Drug: PF-02545920
5 mg twice a day (BID) for 26 weeks. Each 5 mg dose will be taken as 4 tablets: one tablet of 5 mg and 3 tablets of matching placebo. The 5mg dose will not be titrated. Study drug will be provided in weekly blister cards.
Placebo Comparator: Placebo BID
Matching placebo
Other: Placebo
Matching Placebo twice a day (BID) for 26 weeks. Each placebo dose will be taken as 4 tablets of matching Placebo. The placebo dose will not be titrated. Matching placebo will be provided in weekly blister cards.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CAG repeat equal or greater than 36;
  • Total motor score equal or greater than 10;
  • Total functional capacity equal or greater than 7.

Exclusion Criteria:

  • Clinically significant neurologic disorder other than Huntington's disease;
  • Other severe acute psychiatric conditions, mania and/or psychosis;
  • History of neutropenia, and myeloproliferative disorders;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02197130

  Show 56 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02197130     History of Changes
Other Study ID Numbers: A8241021
2014-001291-56 ( EudraCT Number )
Study First Received: July 16, 2014
Last Updated: October 12, 2016

Keywords provided by Pfizer:
Huntington; chorea; total motor score; CAG repeat: total functional capacity; motor cognitive and behavioral symptoms

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2017