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

NCT ID: NCT01806896

Last Updated: 2017-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-01-31

Brief Summary

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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

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Conditions

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Huntington's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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20 mg Arm Cohort A

Group Type EXPERIMENTAL

PF-02545920

Intervention Type DRUG

* 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.

Placebo Arm Cohort A

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Dosing for 28 days.

5 mg Arm Cohort B

Group Type EXPERIMENTAL

PF-02545920

Intervention Type DRUG

* 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.

Placebo Arm Cohort B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

* Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
* Dosing for 28 days.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Centre d'Investigation Clinique (CIC)/ Institut du Cerveau et de la Möelle Epinière (ICM)

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2012-004432-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A8241016

Identifier Type: -

Identifier Source: org_study_id