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Open Label Extension Study To Investigate Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Completed Study A8241021

This study has been terminated.
(Study terminated on 15DEC2016 due to study A8241021 showing no significant difference on primary endpoint between PF-02545920 & placebo. No safety concerns.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02342548
First received: January 15, 2015
Last updated: March 9, 2017
Last verified: March 2017
  Purpose
This study is a 12 month open label extension study of PF-02545920 20 mg dosed BID following study A8241021 in subjects with HD. Primary endpoints will be to assess long-term safety and tolerability of 20 mg BID of PF-02545920. Secondary endpoints will be the change from baseline in the Total Motor Score (TMS)assessment, and/ior the Total maximum Chorea (TMC) assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 6 and 12 months of treatment, and Clinical Global Impression-Improvement score after 6 and 12 months of treatment. Subjects, who were assigned to the 20 mg PF-02545920 dose group in the preceding A8241021 study, will receive 20 mg PF-02545920 without any titration. All other subjects will be titrated to the 20 mg BID dose as follows: 5 mg BID for 7 days, 10 mg BID for 7 days, 15 mg BID for 7 days, then 20 mg BID for the remainder of the treatment phase. Up to 260 subjects may take part in this open label extension

Condition Intervention Phase
Huntington's Disease
Drug: 20 mg BID of PF-02545920
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open Label Extension Study To Investigate The Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Previously Completed Study A8241021

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • White blood count and absolute neutrophil count [ Time Frame: Baseline to Follow-up visit (Day 365) ]
    Monitoring of ANC and WBC

  • Extrapyramidal symptoms [ Time Frame: Baseline to Follow-up visit (Day 365) ]
    Occurence of dystonia or akathisia

  • Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline to Follow-up Visit (Day 365) ]
    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").


Secondary Outcome Measures:
  • Change from baseline in UHDRS Total Motor Score (TMS) after 6 and 12 months of treatment [ Time Frame: Baseline, 6 months and 12 months of treatment in the Open label ]
  • Change from baseline in UHDRS Total Maximum Chorea (TMC) after 6 and 12 months of treatment [ Time Frame: Baseline, 6 months and 12 months of treatment in the Open label ]
  • Change from baseline in • Clinical Global Impression-Improvement score after 6 and 12 months of treatment [ Time Frame: Baseline, 6 months and 12 months of treatment in the Open label ]

Enrollment: 188
Actual Study Start Date: February 25, 2015
Study Completion Date: February 6, 2017
Primary Completion Date: February 6, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 20 mg BID PF-02545920 non-titrated
Subjects who received 20 mg BID in completed study A8241021 will continue to receive 20 mg BID PF-02545920
Drug: 20 mg BID of PF-02545920
All subject who completed A8241021 will receive 20 mg BID (with or without titration)
Experimental: 20mg BID PF-02545920 titrated
Subjects who received either Placebo or 5mg BID of PF-02545920 in completed study A8241021 will be titrated up to 20 mg with 5mg increment per week, over 4 weeks (5mg increment/wk)
Drug: 20 mg BID of PF-02545920
All subject who completed A8241021 will receive 20 mg BID (with or without titration)

  Eligibility

Ages Eligible for Study:   30 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have completed study A8241021
  • Diagnosis of HD, including ≥36 CAG repeats.

Exclusion Criteria:

  • Significant neurological disorder other than Huntington's disease.
  • WBC ≤ 3500/mm3 AND/OR ANC ≤ 2000/mm3 and history of neutropenia or myeolo-proliferative disorders.
  • Any drug related SAE experienced during study A8241021 which were not approved as acceptable for enrollment in A8241022.
  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: NCT02342548

  Show 52 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: NCT02342548     History of Changes
Other Study ID Numbers: A8241022
2014-004900-31 ( EudraCT Number )
OPEN LABEL TO A8241021 ( Other Identifier: Alias Study Number )
Study First Received: January 15, 2015
Last Updated: March 9, 2017

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 May 22, 2017