Trial · NCT01416441
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| 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 |
| PRIMARY | Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total 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 Children's Depression Rating Scale Revised (CDRS-R) Total 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 Pediatric Anxiety Rating Scale (PARS) Total Severity 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 Weight | Baseline to 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. | kilogram | MEAN |
| PRIMARY | Mean Change From Baseline in Waist Circumference | Baseline to 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. | centimeter | MEAN |
| SECONDARY | Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic 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 |
| SECONDARY | Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | Efficacy Sample included all participants who received at least one dose of open-label study medication in this study and had a baseline and at least one post baseline efficacy evaluation. Number analyzed is the number of participants with data available for the analyses at the given timepoint. | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Total YGTSS 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 the analyses at the given timepoint. | score on a scale | MEAN |
| SECONDARY | Response Rates | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) | Efficacy Sample included all participants who received at least one dose of open-label study medication in this study and had a baseline and at least one post baseline efficacy evaluation. Number analyzed is the number of participants with data available for the analyses at the given timepoint. | percentage of participants | NUMBER |
| SECONDARY | Treatment Discontinuation Rates | Up to Week 53 | Enrolled Sample include all participants who met the entrance criteria and enrolled in the trial. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT01416441/outcomes