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
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Pfizer
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
PF-03654746
Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed.
干预措施: PF-03654746 (Drug)
PF-03654746
Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed.
干预措施: Placebo (Drug)
Placebo
Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed.
干预措施: Placebo (Drug)
Placebo
Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed.
干预措施: PF-03654746 (Drug)
结局指标
主要结局
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)
时间窗: Period 1: Days 0, 10, 20, 34, 41; Period 2: Days 0, 10, 20, 34, 41
次要结局
- 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 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 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)