Study Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette's Syndrome
- Registration Number
- NCT01475383
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed. PF-03654746 Placebo Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed. PF-03654746 PF-03654746 Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed. Placebo PF-03654746 Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed.
- Primary Outcome Measures
Name Time Method Change in Total Tic Score (Yale Global Tic Severity Scale) from baseline (D0) to end of the 3 wk stable dosing phase (D41)(primary). Average of the 2 assessments of Total Tic Score in 3 wk stable dosing phase is secondary. Score 0-50 (50 = severe) Period 1: Days 0, 10, 20, 34, 41; Period 2: Days 0, 10, 20, 34, 41
- Secondary Outcome Measures
Name Time Method Change in Clinical Global Impression of Improvement from baseline to end of 3-wk stable dosing phase (primary); average of 2 assessments during 3-wk stable dosing phase is 2ndary. Score 1-7; higher score is worse. Period 1: Days 10, 20, 34, 41; Period 2: Days 10, 20, 34, 41 Change in Tic Symptom Self Report from baseline to end of 3-wk stable dosing phase (primary); average of 2 assessments of TSSR during 3-wk stable dosing phase is 2ndary. Each symptom is scored 0-3; higher score is worse. Period 1: Days 0, 10, 20, 34, 41; Period 2: Days 0, 10, 20, 34, 41 Change in Premonitory Urge for Tic Scale from baseline to end of 3-wk stable dosing phase (primary); average of 2 assessments of PUTS during 3-wk stable dosing phase is 2ndary. Score 9-36; higher score is worse. Period 1: Days 0, 10, 20, 34, 41; Period 2: Days 0, 10, 20, 34, 41 Change in Clinical Global Impression of Severity from baseline to end of 3-wk stable dosing phase. Score 1-7; higher scores indicate more severity. Period 1, Days 0, 41; Period 2: Days 0, 41 Change in Conners' Continuous Performance Test II from baseline to end of 3-wk stable dosing phase. Calculated T-scores (under 40 to 65 and over); higher score is worse. Period 1: Days 0, 20, 41; Period 2: Days 0, 20, 41 Change in Medical Outcomes Study--Sleep Scale from baseline to end of 3-wk stable dosing phase. Score 0-100; a higher score reflect greater amount of quality implied by subscale name. Period 1: Days 0, 10, 20, 34, 41; Period 2: Days 0, 10, 20, 34, 41 Change in Columbia Suicide Severity Rating Scale from baseline to end of 3-wk stable dosing phase. Screening; Period 1: Days 0, 10, 20, 34, 41; Period 2: Days 0, 10, 20, 34, 41 Suicide Behaviors Questionnaire-Revised. Total score greater than 8 require assessment by clinician or mental health professional skilled in evaluation of suicidality. Up to 21 days prior to Baseline (Day 0) Change in Yale-Brown Obsessive-Compulsive Scale from baseline to end of 3-wk stable dosing phase. Items 1-10 have score range of 0-40; higher score is worse. Period 1: Days 0, 41; Period 2: Days 0, 41
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Manhasset, New York, United States