Overview

Study Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette's Syndrome

Status:
Withdrawn
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety and efficacy of an investigational compound designated PF-03654746 compared to placebo in the treatment of adults with Tourette's Syndrome. The study will also explore the pharmacokinetics of PF-03654746 in adults with Tourette's Syndrome.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Criteria
Inclusion Criteria:

- Primary diagnosis of Tourette's Syndrome in English-speaking male or female adults 18
to 55 years of age who are in generally good health.

- Free of medications to treat tics for at least 6 weeks prior to randomization.

- Females of childbearing potential must use medically acceptable birth control for the
duration of the study and for 28 days after study participation.

Exclusion Criteria:

- Tic treatment including protocol-specified drugs, training in tic-suppressing
behavioral techniques, habit reversal training or use of Onabotulinum toxin A
injection.

- History or neurologic evidence of a secondary tic disorder, psychosis, bipolar
disorder, tardive dyskinesia, untreated or unstable DSM-IV Axis I disorder requiring
treatment.