Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease

NCT01806896

Last updated date
Study Location
Centre d'Investigation Clinique (CIC)/ Institut du Cerveau et de la Möelle Epinière (ICM)
Paris Cedex 13, , 75651, France
Contact
1-800-718-1021

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1-800-718-1021

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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
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Must have a diagnosis of Huntington's Disease

- a CAG repeat expansion equal or great than 39

- a Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score equal or greater than 5 and less than 60

- a UHDRS Total Functional Capacity equal or greater than 9

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


- Subjects with evidence or history of severe acute or chronic medical condition or
laboratory abnormality, or significant neurological disorder other than HD.


- Treatment with any antipsychotic medication within 5 weeks of enrollment

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease
Official Title  ICMJE A Phase 2, Double-blind Randomized, Sequential Treatment Group, Placebo-controlled Study To Evaluate The Safety, Tolerability And Brain Cortico-striatal Function Of 2 Doses Of Pf-02545920 In Subjects With Early Huntington's Disease
Brief Summary This study will evaluate the Safety, Tolerability and Brain Function of 2 doses of PF-0254920 in Subjects with Early Huntington's Disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Huntington's Disease
Intervention  ICMJE
  • Drug: PF-02545920
    • Dose will be titrated up every 2 days by 5mg increments: 5mg Days 1-2, 10mg days 3-4, 15mg days 5-6, and reach 20 mg from Days 7 to Day28.
    • Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
    • Treatment for 28 days.
  • Drug: Placebo

    - Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.

    Dosing for 28 days.

  • Drug: PF-02545920
    • 5mg dose
    • Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
    • Dosing for 28 days.
  • Drug: Placebo
    • Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
    • Dosing for 28 days.
Study Arms  ICMJE
  • Experimental: 20 mg Arm Cohort A
    Intervention: Drug: PF-02545920
  • Placebo Comparator: Placebo Arm Cohort A
    Intervention: Drug: Placebo
  • Experimental: 5 mg Arm Cohort B
    Intervention: Drug: PF-02545920
  • Placebo Comparator: Placebo Arm Cohort B
    Intervention: Drug: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2015)
37
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2013)
65
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must have a diagnosis of Huntington's Disease
  • a CAG repeat expansion equal or great than 39
  • a Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score equal or greater than 5 and less than 60
  • a UHDRS Total Functional Capacity equal or greater than 9

Exclusion Criteria:

  • Subjects with evidence or history of severe acute or chronic medical condition or laboratory abnormality, or significant neurological disorder other than HD.
  • Treatment with any antipsychotic medication within 5 weeks of enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 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 France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01806896
Other Study ID Numbers  ICMJE A8241016
2012-004432-31 ( EudraCT 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 May 2017

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