Back to resultsStudy Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette's Syndrome
Primary Purpose
Tourette's Syndrome
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PF-03654746
Placebo
Placebo
PF-03654746
Sponsored by
About this trial
This is an interventional treatment trial for Tourette's Syndrome focused on measuring Tourette's Syndrome in adults, Safety and Efficacy, Randomized, Placebo Control, Cross-over
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
PF-03654746
Placebo
Arm Description
Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed.
Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Change in Columbia Suicide Severity Rating Scale from baseline to end of 3-wk stable dosing phase.
Suicide Behaviors Questionnaire-Revised. Total score greater than 8 require assessment by clinician or mental health professional skilled in evaluation of suicidality.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01475383
Brief Title
Study Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette's Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
See termination reason in detailed description.
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette's Syndrome
Keywords
Tourette's Syndrome in adults, Safety and Efficacy, Randomized, Placebo Control, Cross-over
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-03654746
Arm Type
Active Comparator
Arm Description
Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed.
Intervention Type
Drug
Intervention Name(s)
PF-03654746
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once daily dosing of placebo capsules following the dosing scheme described in 1.1.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once daily dosing of placebo capsules following the dosing scheme described in 1.1
Intervention Type
Drug
Intervention Name(s)
PF-03654746
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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)
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8801035&StudyName=Study%20Evaluating%20The%20Safety%20And%20Efficacy%20Of%20PF-03654746%20In%20Adult%20Subjects%20With%20Tourette%27s%20Syndrome
Description
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Study Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette's Syndrome
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