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

Pfizer

Status and phase: Withdrawn; Phase 2

Conditions: Tourette's Syndrome

Treatments: Drug: PF-03654746; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01475383

A8801035

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

PF-03654746

Active Comparator group

Description:

Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed.

Treatment:

Drug: Placebo

Drug: PF-03654746

Drug: PF-03654746

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed.

Treatment:

Drug: Placebo

Drug: PF-03654746

Drug: PF-03654746

Drug: Placebo