Overview

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

Status:
Terminated

Trial end date:
2017-02-06

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Criteria

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.