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

• ClinicalTrials.gov Identifier: NCT01475383
• Recruitment Status: Withdrawn
• First Posted: November 21, 2011
• Last Update Posted: April 1, 2019
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Tourette's Syndrome	Drug: PF-03654746; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, 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
• Study Start Date: April 2012
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: April 2012

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]
4. 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 ]
5. 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 ]
6. 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 ]
7. 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 ]
8. 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) ]
9. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• 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

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. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01475383
• Other Study ID Numbers: A8801035
• First Posted: November 21, 2011
• Last Update Posted: April 1, 2019
• Last Verified: March 2019

Keywords provided by Pfizer:

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

Additional relevant MeSH terms:

Tourette Syndrome; Syndrome; Disease; Pathologic Processes; 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; Neurodevelopmental Disorders; Mental Disorders