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Tourette's DisorderPhase 3NCT01418339

Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

A Phase 3 study testing Aripiprazole in people with Tourette's Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 39 sites in 6 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 study is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score 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
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
135 participants
Where
39 sitesin 6 countries
Study dates
27 Jul 2011to 6 Nov 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

  • 7 to 17 year old with diagnostic and statistical manual of mental disorders, fourth edition -text revision (DSM-IV-TR) diagnostic criteria for Tourette's disorder (TD), confirmed by the kiddie schedule for affective disorders and schizophrenia - present and lifetime version (K-SADS-PL), including the Diagnostic Supplement 5
  • Has a total tic score (TTS) ≥20 on the yale global tic severity scale (YGTSS) at Screening and Baseline
  • Presenting tic symptoms cause impairment in the participant'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 form (ICF) obtained from a legally acceptable representative \& informed assent at Screening as applicable by study center's Institutional review board/independent ethics committee (IRB/IEC)
  • The participant, 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.
  • Participant receiving psychostimulants for treatment of attention-deficit disorder/Attention-deficit hyperactivity disorder (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), per children's yale-brown obsessive compulsive scale (CY-BOCS) score >16.
  • Taken aripiprazole within 30 days of the Screening visit.
Show all 19Show fewer
  • Received any investigational agent in a clinical trial within 30 days prior to Screening or who were randomized into a clinical trial with Once-weekly aripiprazole at any time.
  • History of neuroleptic malignant syndrome.
  • Sexually active participants not using 2 approved methods of contraception; breastfeeding or pregnant.
  • Risk of committing suicide
  • Bodyweight lower than 16 kg
  • Taken neuroleptic or antiparkinson drugs <14 days prior to randomization.
  • Requiring cognitive-behavioral therapy (CBT) for TD during study.
  • Participant meets DSM-IV-TR criteria for any significant psychoactive substance use disorder within the past 3 months.
  • Positive drug screen
  • Participant 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 study.
  • Inability to swallow tablets or tolerate oral medication
  • Abnormal laboratory test results, vital signs and Electrocardiogram (ECG) results

Trial locations and contacts

39 sites in 6 countries.

39 sites in 6 countries

United States20 sites

  • Study site

    Avon Lake, Ohio, 44012

  • Study site

    Bloomfield Hills, Michigan, 48302

  • Study site

    Bothell, Washington, 98011

  • Study site

    Cleveland, Ohio, 44106

  • Study site

    Dallas, Texas, 75230

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Middleburg Heights, Ohio, 44130

  • Study site

    New Orleans, Louisiana, 70114

  • Study site

    Orange City, Florida, 32763

  • Study site

    Overland Park, Kansas, 66211

  • Study site

    Philadelphia, Pennsylvania, 19139

  • Study site

    Sacramento, California, 95815

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Antonio, Texas, 78258

  • Study site

    Santa Ana, California, 92701

  • Study site

    St. Petersburg, Florida, 33701

  • Study site

    Staten Island, New York, 10312

  • Study site

    Wildomar, California, 92595

Other trials in United States

South Korea6 sites

  • Study site

    Gyeonggi-do, 460727

  • Study site

    Gyeongsang, 626-770

  • Study site

    Incheon, 400-711

  • Study site

    Seoul, 110-769

  • Study site

    Seoul, 138-736

  • Study site

    Seoul, 143-729

Other trials in South Korea

Taiwan5 sites

  • Study site

    Changhua, 50006

  • Study site

    Kaohsiung City, 83301

  • Study site

    Taichung, 40447

  • Study site

    Taipei, 100

  • Study site

    Taipei, 114

Other trials in Taiwan

Canada3 sites

  • Study site

    Kelowna, British Columbia, V1Y 1Z9

  • Study site

    Toronto, Ontario, M5B 1T8

  • Study site

    Whitby, Ontario, L1N 8M7

Other trials in Canada

Mexico3 sites

  • Study site

    Durango, 34000

  • Study site

    León, Guanajuato, 37000

  • Study site

    Monterrey, Nuevo León, 64710

Other trials in Mexico

Hungary2 sites

  • Study site

    Budapest, 1021

  • Study site

    Szeged, 6725

Other trials in Hungary

About this study

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

The goal of the current study is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's Disorder.

Being tested
Aripiprazole, Placebo
Keywords
Tourette's Disorder, Tic disorders
Medical subject headings
Tourette Syndrome, Tic Disorders

What participants receive

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

  • AripiprazoleDrug

    Also called ABILIFY

    Aripiprazole tablet administered orally once a week.

  • PlaceboDrug

    Aripiprazole-matching placebo tablet administered orally once a week.

Study groups in NCT01418339
Study groupRoleWhat they receive
AripiprazoleExperimentalAripiprazole was administered orally once a week (QW) for 8 weeks in a double-blind manner. Participants randomized to aripiprazole received aripiprazole tablets at a starting dose of 52.5 milligrams (mg) QW on Day 0. At Week 1, according to the investigator's discretion based on efficacy and tolerability, the dose of aripiprazole could remain at 52.5 mg QW or could be increased to 77.5 mg QW. The dose could be increased to 110 mg QW as early as Week 2. For the remainder of the study (up to Week 8), the dose was to be adjusted up and down among these three dose levels, as determined by the investigator.
Receives: Drug: Aripiprazole
PlaceboPlacebo comparatorParticipants randomized to placebo received aripiprazole-matching placebo, tablet, orally, QW for 8 weeks in a double-blind manner.
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline in Yale Global Tic Severity Scale (YGTSS) - Total Tic Score (TTS)

    The YGTSS is a semi-structured clinical interview designed to measure the tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were 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. The YGTSS TTS was the summation of the severity scores of motor and vocal tics. The TTS ranged from 0 (none) to 50 (severe) with a higher score represent more severe symptoms (greater reduction from baseline for greater improvement). Mixed Effect Repeated Measure Model (MMRM) analysis was performed.

    Measured: Baseline to Week 8

Secondary outcomes (2)

  1. Change From Baseline in Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) Score

    The severity of illness and efficacy of study medication for each participant were rated using the CGI-TS scale. The study physician rated the participants total improvement whether or not it is due to study treatment. All responses were compared to the participants condition at Baseline (Day 0). 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), with lower score indicating better improvement. A negative change from Baseline indicates improvement. MMRM analysis was performed.

    Measured: Baseline to Week 8

  2. Change From Baseline in Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) Total Score

    The GTS-QOL is a disease-specific patient-reported scale for the measurement of health-related quality of life in participants with Tourette's Disorder, taking into account the complexity of the clinical picture of the disease. The questionnaire consists of a 27-item Tourette's Disorder-specific scale with 4 subscales (psychological, physical, obsessional, and cognitive). The GTS-QOL total score ranged from 0 (extremely dissatisfied with life) and 100 (extremely satisfied with life). A positive change from Baseline indicates improvement. MMRM analysis was performed.

    Measured: Baseline to 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 posted17 Aug 2011 (estimated)
  2. Study start27 Jul 2011
  3. Primary completion6 Nov 2013
  4. Study completion6 Nov 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
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01418339
Sponsor's protocol ID
31-10-272
Other IDs
2011-000467-27
Status last verified
Sep 2021
First submitted
1 Aug 2011
Last updated
7 Oct 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole in people with Tourette's Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 39 sites in 6 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 19 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 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, South Korea, Taiwan, Canada, Mexico and 1 more country. 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 7 Oct 2021). 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 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 NCT01418339.

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 7 Oct 2021.

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