Chronic Motor or Vocal Tic DisorderPhase 3NCT00706589
Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette's Disorder
A Phase 3 study testing aripiprazole in people with Chronic Motor or Vocal Tic Disorder and Tourette's Disorder, run by Korea Otsuka Pharmaceutical Co., Ltd. at 6 sites in South Korea.
Trial summary
The purpose of this trial is to demonstrate the efficacy and safety of aripiprazole in children and adolescents aged 6~18 years with chronic tic disorders or Tourette's disorder Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Chronic Motor or Vocal Tic Disorder, 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
- 61 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Oct 2008to Apr 2010
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who can provide an assent form signed by themselves and informed consent form by their legal representatives prior to performing of any study procedures.
- Male or female children and adolescents aged 6 to 18 years
- Patients who are diagnosed with chronic tic disorders(Motor or Phonic) or Tourette's disorder according to DSM-IV(Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition)(using K-SADS-PL-K (Kiddle-Schedule for Affective Disorders and Schizophrenia,Present and Lifetime Version-Korean version)) and require drug therapy.
- The total tic score of the K-YGTSS (Korean version of Yale Global Tic Severity Scale)is more than 22 at baseline
Who cannot join
- Patients with secondary tic symptoms accompanied by Tardive tics, Huntington disease, neuroacanthocytosis, mental retardation, or autism
- Patients with IQ (Intelligence quotient) (assessed using KEDI-WISC (Korean educational Development Institute-Wechsler Intelligence Scale for children)) 70 and lower than 70
- Patients with a history of neuroleptic malignant syndrome
- Patients with antipsychotic or alcohol use disorder (abuse, dependence, and/or withdrawal) according to DSM-IV criteria for the past 3 months
- Patients with a history of allergy or hypersensitivity reaction to aripiprazole
- Patients with a history of resistance to treatment with antipsychotics
- Patients who have participated in another clinical study within 1 month prior to screening
- Patients who have previously taken aripiprazole or participated in a clinical study with aripiprazole
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Inha University Hospital
Inchon, 400-711
Seoul National University Hospital
Seoul, 110-744
Yonsei University Severance Hospital
Seoul, 120-752
Samsung Medical Center
Seoul, 135-710
Asan Medical Center
Seoul, 138-736
Chung-Ang Univ. Medical center
Seoul, 156-755
About this study
Official title: A Randomized, Double-blind, Dose-adjustment, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aripiprazole in Children and Adolescents With Chronic Tic Disorders or Tourette's Disorder
The purpose of this trial is to demonstrate the efficacy and safety of aripiprazole in children and adolescents aged 6~18 years with chronic tic disorders or Tourette's disorder
- Being tested
- aripiprazole, placebo
- Keywords
- Chronic Motor Tic disorder, Chronic Phonic Tic disorder, Tourette's disorder, Aripiprazole, Abilify, Children, Adolescent
- Medical subject headings
- Tic Disorders, Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazoleDrug
Also called Abilify
Initial dose : 2mg, Maximum dose : 20mg
placeboDrug
Initial dose: 2mg, Maximum dose:20mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Aripiprazole 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol) Receives: Drug: aripiprazole |
| 2 | Placebo comparator | Placebo 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol) Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7)
The meaning of the total tic scores is a sum of the total motor tic score and total phonic tic score and the total tic score will be indicated from zero point to 50 points. And also, for the global tic severity scale is sum of the total tic scores and impairment score and it will be indicated from zero point to 100 points. Additionally, for the imparment score is also indicated from zero to 50 points same as total tic scores. And it is divided as 0 point, 10 point, 20 point and etc… Lastly, someone who gets a high score, it will be considered worse result.
Measured: 10 week
Secondary outcomes (1)
1)Percent Change of Total Tic Scores on the Korean Version of YaleGlobalTicseverity Scale.2)Response Rate Assessed With the Tic Score ClinicalGlobalImpressionImprovementScale.3)Mean Change in Scores on the Tic Score ClinicalGlobal ImpressionSeverityScale.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2010
- Study completionApr 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Motor or Vocal Tic DisorderStudies of the same condition, open and under way.
- 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Soochurl Cho, MD. Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706589
- Sponsor's protocol ID
- 031-KOA-0703
- Status last verified
- Jun 2013
- First submitted
- 25 Jun 2008
- Last updated
- 26 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Yoo HK, Joung YS, Lee JS, Song DH, Lee YS, Kim JW, Kim BN, Cho SC. A multicenter, randomized, double-blind, placebo-controlled study of aripiprazole in children and adolescents with Tourette's disorder. J Clin Psychiatry. 2013 Aug;74(8):e772-80. doi: 10.4088/JCP.12m08189.
PubMed 24021518
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Dose-adjustment, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aripiprazole in Children and Adolescents With Chronic Tic Disorders or Tourette's Disorder
- ClinicalTrials.gov ID
- NCT00706589
- Acronym / sponsor ID
- 031-KOA-0703
- Keywords
- Chronic Motor Tic disorder, Chronic Phonic Tic disorder, Tourette's disorder, Aripiprazole, Abilify, Children, Adolescent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Oct 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Posted 26 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to demonstrate the efficacy and safety of aripiprazole in children and adolescents aged 6~18 years with chronic tic disorders or 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 |
|---|---|---|
| 1 | Experimental | Drug: aripiprazoleAripiprazole 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol) |
| 2 | Placebo comparator | Drug: placeboPlacebo 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients who can provide an assent form signed by themselves and informed consent form by their legal representatives prior to performing of any study procedures.
- Male or female children and adolescents aged 6 to 18 years
- Patients who are diagnosed with chronic tic disorders(Motor or Phonic) or Tourette's disorder according to DSM-IV(Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition)(using K-SADS-PL-K (Kiddle-Schedule for Affective Disorders and Schizophrenia,Present and Lifetime Version-Korean version)) and require drug therapy.
- The total tic score of the K-YGTSS (Korean version of Yale Global Tic Severity Scale)is more than 22 at baseline
Key exclusion criteria (8 listed)
- Patients with secondary tic symptoms accompanied by Tardive tics, Huntington disease, neuroacanthocytosis, mental retardation, or autism
- Patients with IQ (Intelligence quotient) (assessed using KEDI-WISC (Korean educational Development Institute-Wechsler Intelligence Scale for children)) 70 and lower than 70
- Patients with a history of neuroleptic malignant syndrome
- Patients with antipsychotic or alcohol use disorder (abuse, dependence, and/or withdrawal) according to DSM-IV criteria for the past 3 months
- Patients with a history of allergy or hypersensitivity reaction to aripiprazole
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: AbilifyInitial dose : 2mg, Maximum dose : 20mg | Drug | 1 |
| placeboInitial dose: 2mg, Maximum dose:20mg | Drug | 2 |
Primary outcome
Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7)
Time frame: 10 week
The meaning of the total tic scores is a sum of the total motor tic score and total phonic tic score and the total tic score will be indicated from zero point to 50 points. And also, for the global tic severity scale is sum of the total tic scores and impairment score and it will be indicated from zero point to 100 points. Additionally, for the imparment score is also indicated from zero to 50 points same as total tic scores. And it is divided as 0 point, 10 point, 20 point and etc… Lastly, someone who gets a high score, it will be considered worse result.
1 secondary outcome
1)Percent Change of Total Tic Scores on the Korean Version of YaleGlobalTicseverity Scale.2)Response Rate Assessed With the Tic Score ClinicalGlobalImpressionImprovementScale.3)Mean Change in Scores on the Tic Score ClinicalGlobal ImpressionSeverityScale.
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24021518Yoo HK, Joung YS, Lee JS, Song DH, Lee YS, Kim JW, Kim BN, Cho SC. A multicenter, randomized, double-blind, placebo-controlled study of aripiprazole in children and adolescents with Tourette's disorder. J Clin Psychiatry. 2013 Aug;74(8):e772-80. doi: 10.4088/JCP.12m08189.
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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.
Soochurl Cho, MD. Ph.D principal investigator
Seoul National University Hospital
6 sites in 1 country: 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 Chronic Motor or Vocal Tic Disorder and Tourette's Disorder, run by Korea Otsuka Pharmaceutical Co., Ltd. at 6 sites in South Korea.
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 4 inclusion and 8 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 26 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. 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 26 Jul 2013). 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?
Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7) (time frame: 10 week). 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 NCT00706589, 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 26 Jul 2013.