Randomized, Placebo Controlled Phase 2 Study of the Efficacy and Safety of the PDE10a inhibitor, PF-02545920, in Subjects with Huntington's disease

(ClinicalTrials.gov identifier: NCT02197130) 

 Purpose

 This Phase 2 clinical study is a 26 week, randomized, parallel group, double blind comparison of PF-02545920   5 mg, PF-02545920 20 mg, and placebo dosed BID (twice/day) in the treatment of motor impairment of subjects with Huntington's Disease. PF-025459290 is an inhibitor of an enzyme found predominantly in the striatum called phosphodiesterase 10A (PDE10A).  Approximately 260 subjects are planned to be randomized in the study. The 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. 

Study Type:

Interventional

Primary Outcome Measures:

  • Change from baseline in UHDRS Total Motor Score (TMS) after 26 weeks of treatment

Secondary Outcome Measures:

  • White blood count and absolute neutrophil count
  • Extrapyramidal symptoms (occurence of dystonia or akathisia (defined as inability to sit still))
  • Change from baseline in the Total Maximum Chorea (TMC) score of the UHDRS after 13 and 26 weeks of treatment
  • Clinical Global Impression-Improvement score after 13 and 26 weeks of treatment.
  • Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
    • C-SSRS assessed whether participant experienced following: completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior,  suicidal ideation, any suicidal behavior or ideation, self-injurious behavior.

Estimated Enrollment:

260

Study Start Date:

August 2014

Estimated Study Completion Date:

February 2016

Estimated Primary Completion Date:

February 2016 (Final data collection date for primary outcome measure)

Eligibility:

Ages Eligible for Study:  

30 to 65 Years of age

Genders Eligible for Study:  

Both

Accepts Healthy Volunteers:  

No

 

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;
  • Clinical evidence of unstable psychiatric illness.

Clinical Trial Locations and Contacts

Call 1-800-718-1021 for site information

 

Want more info?

Contact: Pfizer CT.gov Call Center

1-800-718-1021, or visit:

 

http://www.clinicaltrials.gov/ct2/show/NCT02197130