Trial · NCT01727700
Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
NCT01727700, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2015-02-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder. Trials, record NCT01727700. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01727700
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
- NCT number
- NCT01727700
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 133 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Tourette's Disorder, Tic Disorder
- Interventions
- Aripiprazole, Placebo
- First posted
- 2012-11-16
- Last updated
- 2015-02-13
- Results first posted
- 2015-02-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS). | Baseline to Week 8 | 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. |
| Secondary | Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8. | 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. |
| Secondary | Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score | Baseline to Week 8 | 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. |
| Secondary | Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score | Baseline to Week 8 | 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. |
| Secondary | Response Rate | Week 8 | 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. |
| Secondary | Treatment Discontinuation Rate | Week 8 | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS). | Baseline to Week 8 | Intent-to-Treat (ITT) Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8. | Week 8 | ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score | Baseline to Week 8 | ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score | Baseline to Week 8 | ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Response Rate | Week 8 | ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group. | Percentage of Responders | NUMBER |
| SECONDARY | Treatment Discontinuation Rate | Week 8 | ITT Population: All participants randomly assigned to the double-blind treatment. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS). | Aripiprazole Low Dose | -13.35 | Standard Error 1.59 | Units on a scale | |
| Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS). | Aripiprazole High Dose | -16.94 | Standard Error 1.61 | Units on a scale | |
| Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS). | Placebo | -7.09 | Standard Error 1.55 | Units on a scale | |
| Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8. | Aripiprazole Low Dose | 2.12 | Standard Error 0.21 | Units on a scale | |
| Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8. | Aripiprazole High Dose | 2.13 | Standard Error 0.21 | Units on a scale | |
| Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8. | Placebo | 3.15 | Standard Error 0.2 | Units on a scale | |
| Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score | Aripiprazole Low Dose | -26.69 | Standard Error 3.34 | Units on a scale | |
| Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score | Aripiprazole High Dose | -32.80 | Standard Error 3.39 | Units on a scale | |
| Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score | Placebo | -13.43 | Standard Error 3.27 | Units on a scale | |
| Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score | Aripiprazole Low Dose | -1.35 | Standard Error 0.19 | Units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aripiprazole Low Dose | 44 | |
| Overall Study | STARTED | Aripiprazole High Dose | 45 | |
| Overall Study | STARTED | Placebo | 44 | |
| Overall Study | COMPLETED | Aripiprazole Low Dose | 42 | |
| Overall Study | COMPLETED | Aripiprazole High Dose | 35 | |
| Overall Study | COMPLETED | Placebo | 42 | |
| Overall Study | NOT COMPLETED | Aripiprazole Low Dose | 2 | |
| Overall Study | NOT COMPLETED | Aripiprazole High Dose | 10 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Aripiprazole Low Dose | 3 | 44 | |
| other | Nausea | Gastrointestinal disorders | Aripiprazole High Dose | 4 | 45 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 44 | |
| other | Vomiting | Gastrointestinal disorders | Aripiprazole Low Dose | 2 | 44 | |
| other | Vomiting | Gastrointestinal disorders | Aripiprazole High Dose | 3 | 45 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 2 | 44 | |
| other | Fatigue | General disorders | Aripiprazole Low Dose | 3 | 44 | |
| other | Fatigue | General disorders | Aripiprazole High Dose | 7 | 45 | |
| other | Fatigue | General disorders | Placebo | 0 | 44 | |
| other | Nasopharyngitis | Infections and infestations | Aripiprazole Low Dose | 3 | 44 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aripiprazole Low Dose | ||
| Total, all-cause mortality | Aripiprazole High Dose | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Aripiprazole Low Dose | 21 | 44 |
| Total, other adverse events | Aripiprazole High Dose | 29 | 45 |
| Total, other adverse events | Placebo | 8 | 44 |
| Total, serious adverse events | Aripiprazole Low Dose | 0 | 44 |
| Total, serious adverse events | Aripiprazole High Dose | 0 | 45 |
| Total, serious adverse events | Placebo | 0 | 44 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28686474 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01727700
GET https://conductscience.org/api/trials/v1/NCT01727700/events?page=2