Trial · NCT03567291
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting Treatment Emergent Adverse Events (AEs) for Parts A & B Combined | Day 1 to Week 55 | Safety analysis set included all participants who received at least 1 dose of study drug. | Participants | NUMBER |
| PRIMARY | Number of Participants Reporting Treatment Emergent Adverse Events (AEs) in Part B (Period II) | Weeks 28 to 30 | Population includes all participants who completed Period I, were randomized in Period II, and who were administered any study drug in the randomized withdrawal period, Part B (Period II). | Participants | NUMBER |
| PRIMARY | Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score | Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number analyzed' signifies participants evaluable for specified categories. | Units On A Scale | MEAN |
| PRIMARY | Change From Baseline in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score | Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number analyzed' signifies participants evaluable for specified categories. | Units On A Scale | MEAN |
| PRIMARY | Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Parent Version) Total Score at Week 30 | Week 28, Week 30 | Population includes all participants who completed Period I, were randomized in Period II, and who were administered any study drug in the randomized withdrawal period, Part B (Period II). Here, 'number analyzed' signifies participants evaluable for specified categories. | Units On A Scale | MEAN |
| PRIMARY | Change From Randomized Withdrawal Baseline (Week 28) in the Children's Depression Inventory Second Edition (CDI-2; Self-reported Version) Total Score at Week 30 | Week 28, Week 30 | Population includes all participants who completed Period I, were randomized in Period II, and who were administered any study drug in the randomized withdrawal period, Part B (Period II). Here, 'number analyzed' signifies participants evaluable for specified categories. | Units On A Scale | MEAN |
| PRIMARY | Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline, Weeks 2, 4, 8, 15, 28, 34, 41, 54, 55 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number analyzed' signifies participants evaluable at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) at Randomized Withdrawal Baseline Visit (Week 28) and Week 30 | Week 28, Week 30 | Population includes all participants who completed Period I, were randomized in Period II, and who were administered any study drug in the randomized withdrawal period, Part B (Period II). Here, 'number analyzed' signifies participants evaluable at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) | Baseline, Weeks 8, 15, 28, 41, 54, and 55 | ITT analysis set includes all participants enrolled in part I. Here, 'number analyzed' signifies participants evaluable at specified time points. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score | Baseline, Weeks 8, 15, 28, 41, 54, and 55 | Data were not collected during Part B (Period II). ITT analysis set includes all participants enrolled in part I. Here, 'number analyzed' signifies participants evaluable at specified time points. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score | Baseline, Weeks 8, 15, 28, 41, 54, and 55 | Data were not collected during Part B (Period II). ITT analysis set includes all participants enrolled in part I. Here, 'number analyzed' signifies participants evaluable at specified time points. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Child and Adolescent Gilles de la Tourette Syndrome - Quality of Life (C&A-GTS-QOL) Activities of Daily Living (ADL) Subscale Score | Baseline, Weeks 6, 28, 34, 54 | Data were not collected during Part B (Period II). ITT analysis set includes all participants enrolled in part I. Here, 'number analyzed' signifies participants evaluable at specified time points. | Units on a scale | MEAN |
| SECONDARY | Change From Randomized Withdrawal Baseline (Week 28) in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) to Week 30 | Week 28, Week 30 | All participants that completed Part 1, were randomized to Part 2, received at least one dose of study drug in the randomized withdrawal period and have an YGTSS TTS at both week 28 visit (randomized withdrawal baseline) and week 30 visit, and have a ≥25% reduction in the TTS from baseline in the parent study to week 28. | Units on a scale | LEAST_SQUARES_MEAN |
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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