Tourette SyndromePhase 3NCT03487783
Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette's Syndrome
A Phase 3 study testing Aripiprazole Oral Solution in people with Tourette Syndrome, run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the safety, efficacy, tolerability and steady-state plasma trough concentration of flexible-dosed aripiprazole once-daily administration in children and adolescents with Tourette's syndrome. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Aripiprazole Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- 2 May 2018to 14 Feb 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written informed consent form must be obtained from a legal guardian (and the subject)
- The subject and the designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator.
- The subject is a male or female child or adolescent, 6-18 years of age (6≤ Age <18) at the time of Baseline Visit (V2);
- The subject meets the current DSM-IV-TR diagnostic criteria for Tourette's syndrome and requires drug therapy;
- The subject has a TTS ≥ 22 on the YGTSS at Baseline Visit (V2);
Who cannot join
- Women of childbearing potential (WOCBP) who will not commit to utilizing the approved birth control methods or who will not remain abstinent during the trial and for 8 weeks following the final dose of study drug; Note: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea 12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone level ≥ 35 mIU/mL].
- Females who have a positive pregnancy test result or who are pregnant or breast-feeding;
- Subjects who have secondary tic symptoms accompanied by late-onset tics, Huntington's chorea, neuroacanthocytosis, mental retardation, or autism;
- Subjects who have comorbidities requiring drug therapy, such as attention deficit / attention-deficit hyperactivity, obsessive-compulsive disorder, or oppositional defiant disorder (if a case is judged by the investigator that drug therapy is not required for any of the above diseases during this study, then the patient is eligible to participate in this trial);
- Subjects who have lower intelligence;
- Subjects who have a current diagnosis of bipolar disorder, mental disorder, schizophrenia, or depressive disorder;
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- Subjects who have records of neuroleptic malignant syndrome;
- Subjects who have experienced episodes of epileptic seizure in the past year;
- Subjects who have a history of severe traumatic brain injury or stroke;
- Subjects who have any unstable medical conditions or are currently ill (e.g., congenital heart disease, arrhythmia or cancer), which, in the investigator's judgment, will put them at a risk of major adverse event during this trial, or will interfere with safety and efficacy assessments
- Subjects who require both drug therapy and cognitive-behavioral therapy (CBT, including habitual inversion therapy, cognitive therapy, relaxation training, etc.) during the trial period;
- Patients with the following laboratory test results, vital signs, measurements, and electrocardiogram (ECG) results will be excluded:
- QTc > 450 msec (male), QTc > 470 msec (female)
- Platelets (< lower limit)
- Hemoglobin (< lower limit)
- Neutrophils (< lower limit)
- AST (SGOT) or ALT (SGPT) (> upper limit)
- Creatinine (> upper limit) Subjects should be excluded if they have any other abnormal laboratory tests, vital sign results, or ECG findings which in the investigator's judgment is medically significant and will impact the safety of the subject or the interpretation of the trial results;
- Subjects who have a body weight of lower than 15 kg;
- Subjects who have been known to be with allergy or hypersensitivity to aripiprazole or other dihydroquinolones (e.g., carteolol, vesnarinone and cilostazol);
- Subjects who have participated in any clinical trial of any drugs within the past one month;
- Subjects who may require concomitant treatments prohibited as per the protocol during the trial period (referring to Section 7 Prohibited and Restricted Therapies);
- Subjects who were previously enrolled in clinical trials of aripiprazole (excluding investigator-sponsored trials);
- Subjects who are considered to have developed resistance to antipsychotic drugs by the investigator due to lack of efficacy after receiving 2 different antipsychotic drugs at reasonable doses and at least 3 weeks of treatment with each respectively;
- Subjects who are considered to have developed resistance to aripiprazole by the investigator due to lack of efficacy after an adequate time of treatment with adequate dose;
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anding Hospital of Capital Medical University
Beijing, Beijing Municipality, 100088
About this study
Official title: A Multicenter, Randomized, Double-Blind, Flexible-Dosed, Placebo-Controlled, Parallel-Group Clinical Trial Evaluating the Efficacy and Safety of Aripiprazole Oral Solution in Children and Adolescents With Tourette's Syndrome
This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the safety, efficacy, tolerability and steady-state plasma trough concentration of flexible-dosed aripiprazole once-daily administration in children and adolescents with Tourette's syndrome. A total of around 120 subjects will be randomized to aripiprazole (2~20 mg) or placebo in a 1:1 ratio (approximately 60 subjects in each group), for treatment of 8 weeks.
Read the detailed description
Screening phase: It can last up to 42 days, including the screening visit (V1), a washout period when applicable, additional screening visit (V1a) and baseline visit (V2). The screening phase will serve the following purposes: 1) To allow for appropriate washout of prohibited medications; 2) To review the screening data; 3) To establish a pretreatment baseline of critical outcome measures.
Treatment phase: It lasts 8 weeks; the purpose of the treatment phase is to assess the efficacy, safety, tolerability and steady-state plasma trough concentration of aripiprazole in the treatment of children and adolescents with Tourette's syndrome.
Safety follow-up phase: All subjects will be followed up for safety (adverse events) at Day 16 after the final medication via telephone
- Conditions
- Tourette Syndrome
- Being tested
- Aripiprazole Oral Solution, Placebo Oral Solution
- Keywords
- Tourette, Aripiprazole Oral Solution
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole Oral SolutionDrug
Also called Aripiprazole OS, Abilify
Aripiprazole 2-20 mg/day (2-20 mL/day)
Placebo Oral SolutionDrug
Also called Placebo
Placebo 2-20 mg/day (2-20 mL/day)
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole Oral Solution | Experimental | 1 mg/mL, 2-20 mg/day (2-20 mL/day), once daily for 8 weeks, administered at about the same time every day, either before or after meal Receives: Drug: Aripiprazole Oral Solution |
| Placebo Oral Solution | Placebo comparator | 2-20 mg/day (2-20 mL/day), once daily for 8 weeks, administered at about the same time every day, either before or after meal Receives: Drug: Placebo Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline to Week 8 (or endpoint) in YGTSS TTS.
The objective of the primary analysis is to compare the efficacy of flexible-dosed aripiprazole oral solution (2~20 mg/day) with placebo in the suppression of tics in children and adolescents with a diagnosis of Tourette's syndrome. The efficacy is assessed by the changes of total tic scores (TTS) from randomization to the last visit (Week 8) on the Yale Global Tic Severity Scale (YGTSS).
Measured: Baseline and 8 weeks (or endpoint)
Secondary outcomes (4)
Percentage change from Baseline to Week 8 (or endpoint) in YGTSS TTS;
The efficacy is assessed by the percentage subjects changes of total tic scores (TTS) from randomization to the last visit (Week 8) on the Yale Global Tic Severity Scale (YGTSS)
Measured: Baseline and 8 weeks (or endpoint)
Response rate on TS-CGI Improvement scale
The response rate (the percentage of patients with a score of 1 or 2) is assessed by TS-CGI Improvement scale from Baseline to Week 8 (or endpoint)
Measured: Baseline and 8 weeks (or endpoint)
Partial remission rate on TS-CGI Improvement scale
The partial remission rate (the percentage of patients with a score of 3) is assessed by TS-CGI Improvement scale from Baseline to Week 8 (or endpoint)
Measured: Baseline and 8 weeks (or endpoint)
Changes from Baseline to Week 8 (or endpoint) in TS-CGI Severity scale scores
The efficacy is assessed by changes from Baseline to Week 8 (or endpoint) in TS-CGI Severity scale scores
Measured: Baseline and 8 weeks (or endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start2 May 2018
- Primary completion14 Feb 2020
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patyman Juma, Study director, Otsuka Beijing Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487783
- Sponsor's protocol ID
- 031-403-00107
- Status last verified
- Jan 2020
- First submitted
- 27 Mar 2018
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He F, Luo J, Huang Y, Hao Y, Sun L, Ke X, Wu B, Chen Y, Han Y, Zhang Y, Liu J, Han H, Xian M, Uki M, Zheng Y. Randomized, double-blind, placebo-controlled trial of aripiprazole oral solution in children and adolescents with Tourette's disorder. Child Adolesc Psychiatry Ment Health. 2024 Jul 18;18(1):88. doi: 10.1186/s13034-024-00764-6.
PubMed 39026306
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Flexible-Dosed, Placebo-Controlled, Parallel-Group Clinical Trial Evaluating the Efficacy and Safety of Aripiprazole Oral Solution in Children and Adolescents With Tourette's Syndrome
- ClinicalTrials.gov ID
- NCT03487783
- Acronym / sponsor ID
- 031-403-00107
- Conditions
- Tourette Syndrome
- Keywords
- Tourette, Aripiprazole Oral Solution
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- 2 May 2018 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 4 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the safety, efficacy, tolerability and steady-state plasma trough concentration of flexible-dosed aripiprazole once-daily administration in children and adolescents with Tourette's syndrome. A total of around 120 subjects will be randomized to aripiprazole (2~20 mg) or placebo in a 1:1 ratio (approximately 60 subjects in each group), for treatment of 8 weeks.
Detailed description
Screening phase: It can last up to 42 days, including the screening visit (V1), a washout period when applicable, additional screening visit (V1a) and baseline visit (V2). The screening phase will serve the following purposes: 1) To allow for appropriate washout of prohibited medications; 2) To review the screening data; 3) To establish a pretreatment baseline of critical outcome measures.
Treatment phase: It lasts 8 weeks; the purpose of the treatment phase is to assess the efficacy, safety, tolerability and steady-state plasma trough concentration of aripiprazole in the treatment of children and adolescents with Tourette's syndrome.
Safety follow-up phase: All subjects will be followed up for safety (adverse events) at Day 16 after the final medication via telephone
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 Oral Solution | Experimental | Drug: Aripiprazole Oral Solution1 mg/mL, 2-20 mg/day (2-20 mL/day), once daily for 8 weeks, administered at about the same time every day, either before or after meal |
| Placebo Oral Solution | Placebo comparator | Drug: Placebo Oral Solution2-20 mg/day (2-20 mL/day), once daily for 8 weeks, administered at about the same time every day, either before or after meal |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Written informed consent form must be obtained from a legal guardian (and the subject)
- The subject and the designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator.
- The subject is a male or female child or adolescent, 6-18 years of age (6≤ Age <18) at the time of Baseline Visit (V2);
- The subject meets the current DSM-IV-TR diagnostic criteria for Tourette's syndrome and requires drug therapy;
- The subject has a TTS ≥ 22 on the YGTSS at Baseline Visit (V2);
Key exclusion criteria (25 listed)
- Women of childbearing potential (WOCBP) who will not commit to utilizing the approved birth control methods or who will not remain abstinent during the trial and for 8 weeks following the final dose of study drug; Note: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea 12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone level ≥ 35 mIU/mL].
- Females who have a positive pregnancy test result or who are pregnant or breast-feeding;
- Subjects who have secondary tic symptoms accompanied by late-onset tics, Huntington's chorea, neuroacanthocytosis, mental retardation, or autism;
- Subjects who have comorbidities requiring drug therapy, such as attention deficit / attention-deficit hyperactivity, obsessive-compulsive disorder, or oppositional defiant disorder (if a case is judged by the investigator that drug therapy is not required for any of the above diseases during this study, then the patient is eligible to participate in this trial);
- Subjects who have lower intelligence;
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 |
|---|---|---|
| Aripiprazole Oral SolutionAlso: Aripiprazole OS, AbilifyAripiprazole 2-20 mg/day (2-20 mL/day) | Drug | Aripiprazole Oral Solution |
| Placebo Oral SolutionAlso: PlaceboPlacebo 2-20 mg/day (2-20 mL/day) | Drug | Placebo Oral Solution |
Primary outcome
Changes from Baseline to Week 8 (or endpoint) in YGTSS TTS.
Time frame: Baseline and 8 weeks (or endpoint)
The objective of the primary analysis is to compare the efficacy of flexible-dosed aripiprazole oral solution (2~20 mg/day) with placebo in the suppression of tics in children and adolescents with a diagnosis of Tourette's syndrome. The efficacy is assessed by the changes of total tic scores (TTS) from randomization to the last visit (Week 8) on the Yale Global Tic Severity Scale (YGTSS).
4 secondary outcomes
Percentage change from Baseline to Week 8 (or endpoint) in YGTSS TTS;
Time frame: Baseline and 8 weeks (or endpoint)
Response rate on TS-CGI Improvement scale
Time frame: Baseline and 8 weeks (or endpoint)
Partial remission rate on TS-CGI Improvement scale
Time frame: Baseline and 8 weeks (or endpoint)
Changes from Baseline to Week 8 (or endpoint) in TS-CGI Severity scale scores
Time frame: Baseline and 8 weeks (or endpoint)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Derived from this study: PubMed 39026306He F, Luo J, Huang Y, Hao Y, Sun L, Ke X, Wu B, Chen Y, Han Y, Zhang Y, Liu J, Han H, Xian M, Uki M, Zheng Y. Randomized, double-blind, placebo-controlled trial of aripiprazole oral solution in children and adolescents with Tourette's disorder. Child Adolesc Psychiatry Ment Health. 2024 Jul 18;18(1):88. doi: 10.1186/s13034-024-00764-6.
- Individual participant dataSharing planned: No
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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.
Patyman Juma study director
Otsuka Beijing Research Institute
1 site 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 Oral Solution in people with Tourette Syndrome, run by Otsuka Beijing Research Institute at 1 site in China.
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 5 inclusion and 25 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 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes from Baseline to Week 8 (or endpoint) in YGTSS TTS. (time frame: Baseline and 8 weeks (or endpoint)). 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 NCT03487783, 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 29 Dec 2020.