Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02197130 |
Date of registration:
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16/07/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease
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Scientific title:
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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 |
Date of first enrolment:
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September 2014 |
Target sample size:
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272 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02197130 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Germany
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Poland
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United Kingdom
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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;
Age minimum:
30 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Huntington's Disease
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Intervention(s)
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Drug: PF-02545920
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Other: Placebo
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Primary Outcome(s)
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Change From Baseline in the Total Motor Score (TMS) Assessment of the Unified Huntington Disease Rating Scale (UHDRS) After 26 Weeks of Treatment.
[Time Frame: Baseline, Week 26]
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Secondary Outcome(s)
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Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Absolute Values)
[Time Frame: Screening, Day 1, 28, 91, and 182]
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Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Follow-up Visit
[Time Frame: Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)]
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Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Absolute Values)
[Time Frame: Screening, Day 1, 28, 91, and 182]
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Clinical Global Impression of Improvement (CGI-I) Scale Score After 13 and 26 Weeks of Treatment.
[Time Frame: Week 13 & Week 26]
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Number of Participants With Adverse Events
[Time Frame: Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)]
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Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormalities)
[Time Frame: Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)]
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Number of Participants With Serious Adverse Events
[Time Frame: Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)]
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Severity of Adverse Events Related to Extrapyramidal Symptoms (EPS) Including Dystonia and Akathisia
[Time Frame: Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)]
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Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Decrease From Baseline)
[Time Frame: Screening, Day 1, 28, 91, and 182]
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Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Increase From Baseline)
[Time Frame: Screening, Day 1, 28, 91, and 182]
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Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria
[Time Frame: Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)]
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Number of Participants With Laboratory Test Abnormalities (With Normal Baseline)
[Time Frame: Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)]
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Change From Baseline in the Total Maximum Chorea (TMC) Score of the UHDRS After 13 and 26 Weeks of Treatment.
[Time Frame: Baseline, Week 13, Week 26]
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Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Increase From Baseline)
[Time Frame: Screening, Day 1, 28, 91, and 182]
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Secondary ID(s)
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2014-001291-56
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A8241021
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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