Trial · NCT01418339

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

NCT01418339, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2021-10-07

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder. Trials, record NCT01418339. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01418339

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
NCT number: NCT01418339
Status: Completed
Phases: Phase 3
Enrollment: 135 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Tourette's Disorder
Interventions: Aripiprazole, Placebo
First posted: 2011-08-17
Last updated: 2021-10-07
Other registries' IDs: eudract:2011-000467-27
Results first posted: 2021-10-07

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline 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 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.
Secondary	Change From Baseline in Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) Score	Baseline to Week 8	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.
Secondary	Change From Baseline in Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) Total Score	Baseline to Week 8	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Yale Global Tic Severity Scale (YGTSS) - Total Tic Score (TTS)	Baseline to Week 8	Modified Intention-to-Treat (mITT) included all participants randomly assigned to the double-blind treatment, excluding participants from the two sites that were terminated. Overall number of participants analyzed is the number of participants with data available for analyses.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) Score	Baseline to Week 8	mITT included all participants randomly assigned to the double-blind treatment, excluding participants from the two sites that were terminated. Overall number of participants analyzed is the number of participants with data available for analyses.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) Total Score	Baseline to Week 8	mITT included all participants randomly assigned to the double-blind treatment, excluding participants from the two sites that were terminated. Overall number of participants analyzed is the number of participants with data available for analyses.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Yale Global Tic Severity Scale (YGTSS) - Total Tic Score (TTS)	Aripiprazole	-12.34	Standard Error 0.88	score on a scale
Change From Baseline in Yale Global Tic Severity Scale (YGTSS) - Total Tic Score (TTS)	Placebo	-7.72	Standard Error 1.23	score on a scale
Change From Baseline in Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) Score	Aripiprazole	2.29	Standard Error 0.12	score on a scale
Change From Baseline in Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) Score	Placebo	2.81	Standard Error 0.17	score on a scale
Change From Baseline in Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) Total Score	Aripiprazole	10.04	Standard Error 1.83	score on a scale
Change From Baseline in Gilles de la Tourette Syndrome - Quality of Life Scale (GTS-QOL) Total Score	Placebo	12.04	Standard Error 2.60	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Aripiprazole	90
Overall Study	STARTED	Placebo	45
Overall Study	COMPLETED	Aripiprazole	78
Overall Study	COMPLETED	Placebo	35
Overall Study	NOT COMPLETED	Aripiprazole	12
Overall Study	NOT COMPLETED	Placebo	10

Source ClinicalTrials.gov

Adverse events24

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
other	Nausea	Gastrointestinal disorders	Aripiprazole	12	90
other	Nausea	Gastrointestinal disorders	Placebo	4	45
other	Vomiting	Gastrointestinal disorders	Aripiprazole	9	90
other	Vomiting	Gastrointestinal disorders	Placebo	1	45
other	Fatigue	General disorders	Aripiprazole	8	90
other	Fatigue	General disorders	Placebo	0	45
other	Increased Appetite	Metabolism and nutrition disorders	Aripiprazole	6	90
other	Increased Appetite	Metabolism and nutrition disorders	Placebo	1	45
other	Headache	Nervous system disorders	Aripiprazole	12	90
other	Headache	Nervous system disorders	Placebo	2	45

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aripiprazole	0	90
Total, all-cause mortality	Placebo	0	45
Total, other adverse events	Aripiprazole	38	90
Total, other adverse events	Placebo	8	45
Total, serious adverse events	Aripiprazole	3	90
Total, serious adverse events	Placebo	0	45

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Aripiprazole vs Placebo: deaths from any cause	Trial comparisons
Aripiprazole vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01418339

GET https://conductscience.org/api/trials/v1/NCT01418339/events?page=2

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