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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Huntington's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Clinically significant neurologic disorder other than Huntington's disease;

- Other severe acute psychiatric conditions, mania and/or psychosis;

- History of neutropenia, and myeloproliferative disorders;

NCT02197130
Pfizer
Completed
Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease

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Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Huntington's Disease
  • 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.
  • 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.
  • 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.
  • Experimental: 20 mg PF-02545920 BID
    20 mg PF-02545920 BID
    Intervention: Drug: PF-02545920
  • Experimental: 5 mg PF-02545920 BID
    5 mg PF-02545920 BID
    Intervention: Drug: PF-02545920
  • Placebo Comparator: Placebo BID
    Matching placebo
    Intervention: Other: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
272
October 2016
September 2016   (Final data collection date for primary outcome measure)

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;
Sexes Eligible for Study: All
30 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   Poland,   United Kingdom,   United States
 
 
NCT02197130
A8241021
2014-001291-56 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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