Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Recruiting in Palo Alto (17 mi)

+74 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.

Research Team

Eva Kohegyi, MD

Principal Investigator

Otsuka Pharmaceutical Development & Commercialization, Inc.

Eligibility Criteria

Inclusion Criteria

male or female, 7 to 17 year old (inclusive) at the time of signing consent

meets DSM-IV-TR diagnostic criteria for Tourette's Disorder

Presenting tic symptoms cause impairment in the subject's normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships

Treatment Details

Interventions

• Aripiprazole (Atypical Antipsychotic)
• Placebo (Other)

Participant Groups

Group I: Aripiprazole 5 mg or 10 mg Experimental Treatment 1 Intervention

Aripiprazole 5 mg or 10 mg Immediate Release Once-Daily

Group II: Aripiprazole 10 mg or 20 mg Experimental Treatment 1 Intervention

Aripiprazole 10 mg 20 mg Immediate Release Once-Daily

Group III: Placebo Placebo Group 1 Intervention

Matching Placebo Once-Daily

Aripiprazole is already approved in Canada, Japan for the following indications:

Approved in Canada as Abilify for:

• Schizophrenia
• Bipolar I disorder
• Major depressive disorder
• Irritability associated with autistic disorder

Approved in Japan as Abilify for:

• Schizophrenia
• Bipolar disorder
• Major depressive disorder
• Irritability associated with pervasive developmental disorders

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NCT01727700 Wichita, KS

NCT01727700 Cleveland, OH

NCT01727700 Middleburg Heights, OH

NCT01727700 Nashville, TN

More Trial Locations

Who Is Running the Clinical Trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.

Lead Sponsor

Trials

271

Patients Recruited

170,000+