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

NCT02342548

Last updated date
Study Location
The Kirkland Clinic of UAB Hospital
Birmingham, Alabama, 35233, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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
30-66 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects must have completed study A8241021

- Diagnosis of HD, including ≥36 CAG repeats.

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


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Huntington's Disease
Intervention  ICMJE Drug: 20 mg BID of PF-02545920
All subject who completed A8241021 will receive 20 mg BID (with or without titration)
Study Arms  ICMJE
  • 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
    Intervention: Drug: 20 mg BID of PF-02545920
  • 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)
    Intervention: Drug: 20 mg BID of PF-02545920
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 9, 2017)
188
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2015)
260
Actual Study Completion Date  ICMJE February 6, 2017
Actual Primary Completion Date February 6, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years to 66 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Poland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02342548
Other Study ID Numbers  ICMJE A8241022
2014-004900-31 ( EudraCT Number )
OPEN LABEL TO A8241021 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP