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

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ClinicalTrials.gov Identifier: NCT01475383
Recruitment Status : Withdrawn (See termination reason in detailed description.)
First Posted : November 21, 2011
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 25, 2011
First Posted Date  ICMJE November 21, 2011
Last Update Posted Date April 1, 2019
Study Start Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2011)
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) [ Time Frame: Period 1: Days 0, 10, 20, 34, 41; Period 2: Days 0, 10, 20, 34, 41 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01475383 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2011)
  • 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Period 1: Days 0, 41; Period 2: Days 0, 41 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette's Syndrome
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tourette's Syndrome
Intervention  ICMJE
  • Drug: PF-03654746
    20-day dose titration phase: all dosages in capsules starting at 0.25 mg qd x 5 d, then 0.5 mg qd x 5 d, then 1.0 mg qd x 5 d, then 2.0 mg qd x 5 d. If a subject has intolerable, severe, or serious AEs after taking 2 mg qd for 1 to 5 days of dosing, the dose will be decreased by the investigator to 1 mg qd. If, in the investigator's opinion, the subject is determined to be unlikely to tolerate continued dosing at a dose of 1 mg qd, the subject should be discontinued from the study. Subjects remaining in the study will proceed to the 3-week Stable Dosing Phase; doses will be 2 mg daily x 21 days or 1 mg daily x 21 days.
  • Drug: Placebo
    once daily dosing of placebo capsules following the dosing scheme described in 1.1.
  • Drug: Placebo
    once daily dosing of placebo capsules following the dosing scheme described in 1.1
Study Arms  ICMJE
  • Active Comparator: PF-03654746
    Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed.
    Interventions:
    • Drug: PF-03654746
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed.
    Interventions:
    • Drug: Placebo
    • Drug: PF-03654746
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 28, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2011)
30
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01475383
Other Study ID Numbers  ICMJE A8801035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP