Tourette's Syndrome Clinical Trial
Official title:
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
NCT number | NCT01475383 |
Other study ID # | A8801035 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 2012 |
Est. completion date | April 2012 |
Verified date | March 2019 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | Manhasset | New York |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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) | ||
Secondary | 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 |
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