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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Huntington's Disease

Treatments: Drug: Placebo; Drug: PF-02545920

Study type: Interventional

Funder types: Industry

Identifiers

NCT01806896

2012-004432-31 (EudraCT Number)

A8241016

Details and patient eligibility

About

This study will evaluate the Safety, Tolerability and Brain Function of 2 doses of PF-0254920 in Subjects with Early Huntington's Disease.

Enrollment: 37 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 4 patient groups, including a placebo group

20 mg Arm Cohort A

Experimental group

Treatment:

Drug: PF-02545920

Drug: PF-02545920

Placebo Arm Cohort A

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

5 mg Arm Cohort B

Experimental group

Treatment:

Drug: PF-02545920

Drug: PF-02545920

Placebo Arm Cohort B

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo