Study Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette's Syndrome
Status: | Withdrawn |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 4/3/2019 |
Start Date: | April 2012 |
End Date: | April 2012 |
A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study Of The Safety And Efficacy Of PF-03654746 In Adults With Tourette's Syndrome
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.
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.
The study was terminated 11-Apr-2012 due to an internal reassessment of priorities by the
sponsor. The decision to terminate was not based on any safety or efficacy concerns.
sponsor. The decision to terminate was not based on any safety or efficacy concerns.
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.
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