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Tourette's DisorderPhase 3NCT01727700

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

A Phase 3 study testing Aripiprazole in people with Tourette's Disorder and Tic Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 75 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 17 years
Conditions the study is for
Tourette's Disorder, Tic Disorder
What is being tested?
Aripiprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
133 participants
Where
75 sitesin 9 countries
Study dates
Nov 2012to Sep 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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
  • Positive drug screen
  • Subject requires medications not allowed per protocol
  • Use of CYP2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to dosing and for duration of trial
  • Use of herbal medications of any kind and nutritional or dietary supplements for Tourette's disorder within 7 days prior to dosing and for the duration of the trial
  • Inability to swallow tablets or tolerate oral medication
  • Abnormal laboratory test results, vital signs and ECG results

Trial locations and contacts

75 sites in 9 countries.

75 sites in 9 countries

United States55 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Bellevue, Washington

  • Study site

    Bloomfield Hills, Michigan

  • Study site

    Bothell, Washington

  • Study site

    Bradenton, Florida

  • Study site

    Charlottesville, Virginia

  • Study site

    Cleveland, Ohio

  • Study site

    Columbus, Georgia

  • Study site

    Corona, California

  • Study site

    Dallas, Texas

  • Study site

    Dothan, Alabama

  • Study site

    Durham, North Carolina

  • Study site

    Eugene, Oregon

  • Study site

    Gainsville, Florida

  • Study site

    Goodyear, Arizona

  • Study site

    Henrico, Virginia

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Leesburg, Florida

  • Study site

    Louisville, Kentucky

  • Study site

    Maitland, Florida

  • Study site

    Manhasset, New York

  • Study site

    Miami, Florida

  • Study site

    Middleburg Heights, Ohio

  • Study site

    Middleton, Wisconsin

  • Study site

    Mount Arlington, New Jersey

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Naperville, Illinois

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Norwich, Connecticut

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange City, Florida

  • Study site

    Orem, Utah

  • Study site

    Orlando, Florida

  • Study site

    Overland Park, Kansas

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Rochester, New York

  • Study site

    Sacramento, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Santa Ana, California

  • Study site

    Savannah, Georgia

  • Study site

    St. Petersburg, Florida

  • Study site

    Staten Island, New York

  • Study site

    Summit, New Jersey

  • Study site

    Tampa, Florida

  • Study site

    Tucson, Arizona

  • Study site

    Waldorf, Maryland

  • Study site

    Wichita, Kansas

  • Study site

    Wildomar, California

Other trials in United States

Canada4 sites

  • Study site

    Kentville, Nova Scotia

  • Study site

    Parry Sound, Ontario

  • Study site

    Toronto, Ontario

  • Study site

    Whitby, Ontario

Other trials in Canada

Germany4 sites

  • Study site

    Dresden, Germany

  • Study site

    Freiburg im Breisgau, Germany

  • Study site

    Mannheim, Germany

  • Study site

    Würzburg, Germany

Other trials in Germany

Italy3 sites

  • Study site

    Catania, Italy

  • Study site

    Milan, Italy

  • Study site

    Roma, Italy

Other trials in Italy

Mexico3 sites

  • Study site

    Durango, Mexico

  • Study site

    Leon, Mexico

  • Study site

    Mexico City, Mexico City

Other trials in Mexico

Hungary2 sites

  • Study site

    Budapest, Hungary

  • Study site

    Szeged, Hungary

Other trials in Hungary

Romania2 sites

  • Study site

    Bucharest, Romania

  • Study site

    Iași, Romania

Other trials in Romania

Spain1 site

  • Study site

    Madrid, Spain

Other trials in Spain

Sweden1 site

  • Study site

    Gothenburg, Sweden

Other trials in Sweden

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

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.

Read the detailed description

Tourette's Disorder is a neuropsychiatric condition that is characterized by the appearance of tics that can be simple or complex in nature. A tic is a sudden, rapid, recurrent, non-rhythmic, stereotyped motor movement or vocalization. There are a very limited number of medications approved for the treatment of Tourette's Disorder. The goal of the current trial is to obtain efficacy, safety, and tolerability data in a controlled condition of a Once-daily aripiprazole formulation in children and adolescents with Tourette's Disorder. The trial has an 8-week long double-blind treatment period after a pretreatment (screening/washout phase), and the subjects will be followed up for 1 month after the last treatment. The Once-daily tablet formulation that will be evaluated in this trial represents a daily dosage regimen that is intended to be administered to children and adolescents.

Being tested
Aripiprazole, Placebo
Keywords
Tourette Syndrome, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Tic Disorders, Tics, Movement Disorders, Mental Disorders, Aripiprazole
Medical subject headings
Tourette Syndrome, Tic Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Tics, Movement Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AripiprazoleDrug

    Also called Abilify

    Once-daily, tablet

  • PlaceboDrug

Study groups in NCT01727700
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMatching Placebo Once-Daily
Receives: Drug: Placebo
Aripiprazole 5 mg or 10 mgExperimentalAripiprazole 5 mg or 10 mg Immediate Release Once-Daily
Receives: Drug: Aripiprazole
Aripiprazole 10 mg or 20 mgExperimentalAripiprazole 10 mg 20 mg Immediate Release Once-Daily
Receives: Drug: Aripiprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 8

Secondary outcomes (5)

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

    To assess CGI-TS severity, the rater or physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" However, the evaluation of illness was limited to manifestations of TD only. Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The change score was obtained from CGI-TS improvement scale assessment: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.

    Measured: Week 8

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

    The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100). A missing value of a YGTSS item scale could result in a missing Total YGTSS score. A reduction in Total YGTSS score from baseline represents an improvement in symptoms.

    Measured: Baseline to Week 8

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

    The CGI-TS Severity scale (range 0-7) is a single-item rating score, with higher scores representing greater severity or less improvement. A response of 0 (not assessed) is considered and handled as missing data.

    Measured: Baseline to Week 8

  4. Response Rate

    Clinical response is defined as > 25% improvement from baseline to Week 8 in YGTSS TTS or a CGI-TS Change score of 1 [very much improved] or 2 [much improved] at Week 8. Response will be considered as missing only if both YGTSS TTS and CGI-TS change score are missing. As long as one of them is non-missing, response outcome will be determined based on the non-missing score.

    Measured: Week 8

  5. Treatment Discontinuation Rate

    Treatment discontinuation rate will be calculated as the number of discontinued participants (ie, those who were withdrawn from the trial without completing the Week 8 visit) over the number of all randomized participants.

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionAug 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01727700
Sponsor's protocol ID
31-12-293
Status last verified
Feb 2015
First submitted
12 Nov 2012
Last updated
13 Feb 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 28686474

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole in people with Tourette's Disorder and Tic Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 75 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States, Canada, Germany, Italy, Mexico and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS). (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01727700, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2015.

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