Trial · NCT01416441
Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
NCT01416441, 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. Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder. Trials, record NCT01416441. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01416441
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
- NCT number
- NCT01416441
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 170 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Tourette's Disorder
- Interventions
- Aripiprazole
- First posted
- 2011-08-15
- Last updated
- 2021-10-07
- Other registries' IDs
- eudract:2011-000469-11
- Results first posted
- 2021-10-07
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation | From signing of the informed consent up to 30 days after the last dose (Up to Week 52) | An Adverse Event (AE) is defined as any untoward medical occurrence in a participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. Treatment emergent adverse events (TEAE) are adverse events occurring after the onset of study drug administration. |
| Primary | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Baseline to Week 52 | The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Participants with potentially clinically significant lab values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria were reported. Any value outside the normal range was flagged for the attention of the investigator who assessed whether or not a flagged value is of clinical significance. |
| Primary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Baseline to Week 52 | Incidence of clinically relevant abnormal ECG values were reported as change from Baseline in heart rate (Tachycardia - ≥15 beats per minute (bpm), Bradycardia ≤15 bpm; Rhythm (Sinus tachycardia ≥15 bpm increase, Sinus bradycardia decrease of ≥15 bpm from Baseline); Presence of - supraventricular premature beat; ventricular premature beat; supraventricular tachycardia; ventricular tachycardia; atrial fibrillation and flutter. Conduction - Presence of primary, secondary or tertiary atrioventricular block, left bundle-branch block, right bundle-branch block, pre-excitation syndrome, other intraventricular conduction blocked QRS ≥0.12 second increase of ≥0.02 second. Acute, subacute or old Infarction, Presence of myocardial ischemia, symmetrical T-wave inversion. Increase in QTc - QTc ≥450 msec ≥10% increase. Any clinically significant change from Baseline assessed by the Investigator are reported. |
| Primary | Number of Participants With Emergence of Suicidal Ideation, TEAEs Related to Suicide and Suicidality and Suicide Ideation From the Potential Suicide Events Recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline to Week 52 | Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale. |
| Primary | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | The AIMS Scale is an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10) are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28. A negative change from Baseline indicates improvement. |
| Primary | Mean Change From Baseline in Body Mass Index (BMI) | Baseline and Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52) | The BMI kilogram/meter square (i.e. kg/m\^2) was calculated from the Baseline height and the weight at the current visit using one of the following formulae, as appropriate: Weight (kg) divided by \[Height (meters)\]\^2. |
| Primary | Number of Participants With Clinically Significant Changes in Vital Signs | Baseline to Week 52 | Vital signs assessments included orthostatic (supine and standing) blood pressure (BP) measured as millimeter of mercury \[mmHg\]), heart rate, (measured in beats per minute \[bpm\]), body weight (measured in kilograms \[kg\]) and body temperature. Incidence of clinically relevant abnormal values in heart rate, systolic and diastolic blood pressure and weight were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant has been supine for at least 5 minutes and again after the participant has been standing for approximately 2 minutes, but not more than 3 minutes. |
| Primary | Mean Change From Baseline in Simpson Angus Scale (SAS) Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | The SAS is a rating scale used to measure Extrapyramidal symptoms (EPS). The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40. A negative change from Baseline indicates improvement. |
| Primary | Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | The BARS was an EPS rating scale. The BARS was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia). A negative change from Baseline indicates improvement. |
| Primary | Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV) | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | The SNAP-IV, ADHD Inattention subscale contains 19 items, items 1 to 9 measure inattention, items 11 to 19 measure hyperactivity/impulsivity, and item 10 for inattention domain that scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 57. The negative change from Baseline indicates improvement. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation | From signing of the informed consent up to 30 days after the last dose (Up to Week 52) | Safety Sample included all participants who received at least one dose of open-label study medication in this study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Baseline to Week 52 | Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses of the specific category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Baseline to Week 52 | Safety Sample included all participants who received at least one dose of open-label study medication in this study, with data available for analyses. | participants | NUMBER |
| PRIMARY | Number of Participants With Emergence of Suicidal Ideation, TEAEs Related to Suicide and Suicidality and Suicide Ideation From the Potential Suicide Events Recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline to Week 52 | Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses of the specific category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint. | score on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Body Mass Index (BMI) | Baseline and Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52) | Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint. | kg/m^2 | MEAN |
| PRIMARY | Number of Participants With Clinically Significant Changes in Vital Signs | Baseline to Week 52 | Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses of the specific category at given timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mean Change From Baseline in Simpson Angus Scale (SAS) Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint. | score on scale | MEAN |
| PRIMARY | Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint. | score on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV) | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | Safety Sample included all participants who received at least one dose of open-label study medication in this study. Number analyzed is the number of participants with data available for analyses at the given timepoint. | score on a scale | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group201
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation | Aripiprazole (Once Weekly) | Participants with Serious TEAEs | 5 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation | Aripiprazole (Once Weekly) | Participants with Severe TEAEs | 8 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation | Aripiprazole (Once Weekly) | Participants Discontinued Medication due to TEAE's | 6 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation | Aripiprazole (Once Weekly) | Participants with TEAEs | 104 | Participants | |
| Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Aripiprazole (Once Weekly) | Chemistry-Alkaline Phosphatase | 0 | Participants | |
| Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Aripiprazole (Once Weekly) | Chemistry-Alanine Aminotransferase | 1 | Participants | |
| Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Aripiprazole (Once Weekly) | Chemistry-Aspartate Aminotransferase | 1 | Participants | |
| Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Aripiprazole (Once Weekly) | Chemistry-Bilirubin, Total | 4 | Participants | |
| Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Aripiprazole (Once Weekly) | Chemistry-Calcium | 0 | Participants | |
| Number of Participants With Clinically Significant Changes in Laboratory Parameter Values | Aripiprazole (Once Weekly) | Chemistry-Chloride | 0 | Participants |
1 to 10 of 201Source ClinicalTrials.gov
See all 201 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aripiprazole (Once Weekly) | 170 | |
| Overall Study | COMPLETED | Aripiprazole (Once Weekly) | 89 | |
| Overall Study | NOT COMPLETED | Aripiprazole (Once Weekly) | 81 |
Source ClinicalTrials.gov
Adverse events16
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 | Weight increased | Investigations | Aripiprazole (Once Weekly) | 14 | 170 | |
| other | Headache | Nervous system disorders | Aripiprazole (Once Weekly) | 19 | 170 | |
| other | Somnolence | Nervous system disorders | Aripiprazole (Once Weekly) | 11 | 170 | |
| other | Nausea | Gastrointestinal disorders | Aripiprazole (Once Weekly) | 10 | 170 | |
| other | Vomiting | Gastrointestinal disorders | Aripiprazole (Once Weekly) | 12 | 170 | |
| other | Nasopharyngitis | Infections and infestations | Aripiprazole (Once Weekly) | 12 | 170 | |
| other | Upper respiratory tract infection | Infections and infestations | Aripiprazole (Once Weekly) | 12 | 170 | |
| serious | Blood creatinine phosphokinase increased | Investigations | Aripiprazole (Once Weekly) | 1 | 170 | |
| serious | Blood lactate dehydrogenase increased | Investigations | Aripiprazole (Once Weekly) | 1 | 170 | |
| serious | Alanine aminotransferase increased | Investigations | Aripiprazole (Once Weekly) | 1 | 170 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aripiprazole (Once Weekly) | 0 | 170 |
| Total, other adverse events | Aripiprazole (Once Weekly) | 57 | 170 |
| Total, serious adverse events | Aripiprazole (Once Weekly) | 5 | 170 |
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 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/NCT01416441
GET https://conductscience.org/api/trials/v1/NCT01416441/registered?page=2