You are here

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

Last updated on October 13, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Manhasset, New York, 11030 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tourette's Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01475383
Pfizer
Withdrawn
Study Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette's Syndrome

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
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 SummaryThe 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 DescriptionThe 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 DateApril 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now