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

Last updated on May 10, 2018

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

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Study Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette's Syndrome
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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Tourette's Syndrome
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
April 2012
April 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01475383
A8801035
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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