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.
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
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
Taiwan5 sites
Study site
Changhua, 50006
Study site
Kaohsiung City, 83301
Study site
Taichung, 40447
Study site
Taipei, 100
Study site
Taipei, 114
Canada3 sites
Study site
Kelowna, British Columbia, V1Y 1Z9
Study site
Toronto, Ontario, M5B 1T8
Study site
Whitby, Ontario, L1N 8M7
Mexico3 sites
Study site
Durango, 34000
Study site
León, Guanajuato, 37000
Study site
Monterrey, Nuevo León, 64710
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.
- Conditions
- 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 group | Role | What they receive |
|---|---|---|
| Aripiprazole | Experimental | Aripiprazole 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 |
| Placebo | Placebo comparator | Participants 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.
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)
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
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.
- First posted17 Aug 2011 (estimated)
- Study start27 Jul 2011
- Primary completion6 Nov 2013
- Study completion6 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tourette's DisorderStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eva Kohegyi, MD, Study director, Otsuka Pharmaceutical Development & Commercialization, Inc.
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01418339
- Acronym / sponsor ID
- 31-10-272
- Conditions
- Tourette's Disorder
- Keywords
- Tourette's Disorder, Tic disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2011 (actual)
- Primary completion
- 6 Nov 2013 (actual)
- Study completion
- 6 Nov 2013 (actual)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Posted 7 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Experimental | Drug: AripiprazoleAripiprazole 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomized to placebo received aripiprazole-matching placebo, tablet, orally, QW for 8 weeks in a double-blind manner. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AripiprazoleAlso: ABILIFYAripiprazole tablet administered orally once a week. | Drug | Aripiprazole |
| PlaceboAripiprazole-matching placebo tablet administered orally once a week. | Drug | Placebo |
Primary outcome
Change From Baseline in Yale Global Tic Severity Scale (YGTSS) - Total Tic Score (TTS)
Time frame: Baseline to Week 8
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.
2 secondary outcomes
Change From Baseline in Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) Score
Time frame: Baseline to Week 8
Change From Baseline in Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) Total Score
Time frame: Baseline to Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
Related trials for Tourette's Disorder
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Tourette Syndrome, Chronic Tic Disorder
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease
Recruiting
Exploring the Role of Neuroactive Steroids in Tourette Syndrome
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Active, not recruiting
Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
Tourette Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Kohegyi, MD study director
Otsuka Pharmaceutical Development & Commercialization, Inc.
39 sites in 6 countries: see every site and its status.
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?
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.