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

NCT01727700 | Completed Phase 3 Results

• 1 other identifier: 31-12-293
• Study Type: interventional
• Target: 133
• Locations: 9 countries
• Sites: 75

Brief Summary

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.

Conditions

Tourette's Disorder; Tic Disorder

Keywords

Tourette Syndrome; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Tic Disorders; Tics; Movement Disorders; Mental Disorders; Aripiprazole

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).

  The YGTSS is a semi-structured clinical interview designed to measure current (time frame of the past 1 week) tic severity. This scale consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the primary outcome measure in this trial. The YGTSS ranking of impairment score rated on a 50-point scale anchored from 0 (no impairment) to 50 (severe impairment) to assess impairment experienced in areas of self-esteem, family life, social acceptance, and school scores. This is a fully validated scale in adults and has become a standard instrument for the evaluation of the severity of TD in children.

  Baseline to Week 8

Secondary Outcomes (5)

• Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.

  Week 8

• Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score

  Baseline to Week 8

• Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score

  Baseline to Week 8

• Response Rate

  Week 8

• Treatment Discontinuation Rate

  Week 8

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Matching Placebo Once-Daily

Drug: Placebo

Aripiprazole 5 mg or 10 mg

EXPERIMENTAL

Aripiprazole 5 mg or 10 mg Immediate Release Once-Daily

Drug: Aripiprazole

Aripiprazole 10 mg or 20 mg

EXPERIMENTAL

Aripiprazole 10 mg 20 mg Immediate Release Once-Daily

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

Once-daily, tablet

Also known as: Abilify

Aripiprazole 10 mg or 20 mg; Aripiprazole 5 mg or 10 mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Females of childbearing potential must have a negative pregnancy test, must be practicing acceptable double-barrier methods of contraception and must not be pregnant or lactating
• Written informed consent obtained from a legally acceptable representative \& informed assent at Screening as applicable by trial center's IRB/IEC
• The subject, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator

You may not qualify if:

• Clinical presentation and/or history, consistent with another neurologic condition that may have accompanying abnormal movements
• History of schizophrenia, bipolar disorder, or other psychotic disorder
• Subject receiving psychostimulants for treatment of ADD/ADHD and who have developed and/or had exacerbations of tic disorder after initiation of stimulant treatment
• Currently meets DSM-IV-TR criteria for a primary mood disorder
• Severe Obsessive Compulsive Disorder (OCD)
• Taken aripiprazole within 30 days of the Screening visit
• Received any investigational agent in a clinical trial within 30 days prior to Screening, enrolled in studies 31-12-272, 31-12-273, 31-12-274; or who were randomized into a clinical trial with Once-daily aripiprazole at any time
• History of neuroleptic malignant syndrome
• Sexually active patients not using 2 approved methods of contraception
• Females breastfeeding or pregnant (positive blood pregnancy test prior to receiving trial drug)
• Risk of committing suicide
• Body weight lower than 16 kg
• Taken neuroleptic or antiparkinson drugs \< 14 days prior to randomization
• Requiring cognitive behavioral therapy (CBT) for Tourette's during trial
• Subject meets DSM-IV-TR criteria for any significant psychoactive substance use disorder within the past 3 months

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (75)

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Dothan, Alabama, United States

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Goodyear, Arizona, United States

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Tucson, Arizona, United States

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Corona, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Wildomar, California, United States

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Norwich, Connecticut, United States

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Bradenton, Florida, United States

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Gainsville, Florida, United States

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Leesburg, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Orange City, Florida, United States

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Orlando, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Savannah, Georgia, United States

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Naperville, Illinois, United States

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Indianapolis, Indiana, United States

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Overland Park, Kansas, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Waldorf, Maryland, United States

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Bloomfield Hills, Michigan, United States

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Mount Arlington, New Jersey, United States

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Summit, New Jersey, United States

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Albuquerque, New Mexico, United States

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Manhasset, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Staten Island, New York, United States

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Durham, North Carolina, United States

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Cleveland, Ohio, United States

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Middleburg Heights, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Mt. Pleasant, South Carolina, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Orem, Utah, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Henrico, Virginia, United States

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Norfolk, Virginia, United States

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Bellevue, Washington, United States

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Bothell, Washington, United States

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Middleton, Wisconsin, United States

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Kentville, Nova Scotia, Canada

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Parry Sound, Ontario, Canada

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Toronto, Ontario, Canada

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Whitby, Ontario, Canada

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Dresden, Germany, Germany

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Freiburg im Breisgau, Germany, Germany

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Mannheim, Germany, Germany

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Würzburg, Germany, Germany

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Budapest, Hungary, Hungary

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Szeged, Hungary, Hungary

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Catania, Italy, Italy

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Milan, Italy, Italy

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Roma, Italy, Italy

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Mexico City, Mexico City, Mexico

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Durango, Mexico, Mexico

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Leon, Mexico, Mexico

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Bucharest, Romania, Romania

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Iași, Romania, Romania

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Madrid, Spain, Spain

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Gothenburg, Sweden, Sweden

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Related Publications (1)

• Sallee F, Kohegyi E, Zhao J, McQuade R, Cox K, Sanchez R, van Beek A, Nyilas M, Carson W, Kurlan R. Randomized, Double-Blind, Placebo-Controlled Trial Demonstrates the Efficacy and Safety of Oral Aripiprazole for the Treatment of Tourette's Disorder in Children and Adolescents. J Child Adolesc Psychopharmacol. 2017 Nov;27(9):771-781. doi: 10.1089/cap.2016.0026. Epub 2017 Jul 7.

  PMID: 28686474 DERIVED

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Tics; Movement Disorders; Mental Disorders

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.

800 562-3974

Study Officials

• Eva Kohegyi, MD

  Otsuka Pharmaceutical Development & Commercialization, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2012
• First Posted: November 16, 2012
• Study Start: November 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 13, 2015
• Results First Posted: February 13, 2015

Record last verified: 2015-02

Locations

CA (4); SE (1); HU (2); IT (3); US (55); ES (1); RO (2); DE (4); ME (3)