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

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

April 30, 2012

Primary Completion Date

April 30, 2012

Study Completion Date

April 30, 2012

Conditions
Tourette's Syndrome
Interventions
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

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.

Trial Locations (1)

11030

Pfizer Investigational Site, Manhasset

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY