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

Purpose

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.

Condition	Intervention	Phase
Tourette's Syndrome	Drug: PF-03654746 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: Tourette syndrome

MedlinePlus related topics: Tourette Syndrome

U.S. FDA Resources

Further study details as provided by Pfizer:

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) [ Time Frame: Period 1: Days 0, 10, 20, 34, 41; Period 2: Days 0, 10, 20, 34, 41 ] [ Designated as safety issue: No ]

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. [ Time Frame: Period 1: Days 0, 10, 20, 34, 41; Period 2: Days 0, 10, 20, 34, 41 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Enrollment:	1
Study Start Date:	April 2012
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: PF-03654746 Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed.	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.
Placebo Comparator: Placebo Subjects are randomized to either active drug or placebo in Period 1; in Period 2 the sequence is reversed.	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.

Arms

Assigned Interventions

Active Comparator: PF-03654746

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

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.

Placebo Comparator: Placebo

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

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475383

Locations

United States, New York
Pfizer Investigational Site
Manhasset, New York, United States, 11030

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01475383 History of Changes
Other Study ID Numbers:	A8801035
Study First Received:	October 25, 2011
Last Updated:	July 30, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Tourette's Syndrome in adults
Safety and Efficacy
Randomized
Placebo Control
Cross-over

Additional relevant MeSH terms:

Tourette Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders

Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013