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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02197130
• Date of registration: 16/07/2014
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease
• Scientific 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
• Date of first enrolment: September 2014
• Target sample size: 272
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02197130
• 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

Canada, Germany, Poland, United Kingdom, United States

Contacts

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

Key inclusion & exclusion 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;



Age minimum: 30 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Huntington's Disease

Intervention(s)

Drug: PF-02545920

Other: Placebo

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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)]

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]

Clinical Global Impression of Improvement (CGI-I) Scale Score After 13 and 26 Weeks of Treatment. [Time Frame: Week 13 & Week 26]

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)]

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)]

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)]

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)]

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]

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]

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)]

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)]

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]

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]

Secondary ID(s)

2014-001291-56

A8241021

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/11/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02197130