Study Evaluating The Safety, Tolerability And Brain Function Of 2 Doses Of PF-0254920 In Subjects With Early Huntington's Disease
NCT01806896
ABOUT THIS STUDY
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1-800-718-1021
- 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
- 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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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 37 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |