Trial · NCT03664232
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Day 85 in the Autism Behavior Inventory (ABI) Core Domain Score (Social Communication and Restrictive Behaviour) | Baseline (Day 1) to Day 85 | The full analysis set twice daily (FAS-BID) included all randomized participants who had received at least 1 dose of study agent at the BID dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. As per study statistical analysis plan (SAP), data for this outcome measure was planned to be collected and analyzed only on the participants who received BID dosing. | Score on a scale | MEAN |
| PRIMARY | Change From Baseline to Day 85 in the ABI Social Communication Domain Score | Baseline (Day 1) to Day 85 | The FAS-BID included all randomized participants who had received at least 1 dose of study agent at the BID dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. As per study SAP, data for this outcome measure was planned to be collected and analyzed only on the participants who received BID dosing. | Score on a scale | MEAN |
| PRIMARY | Change From Baseline to Day 85 in the ABI Repetitive/Restrictive Behavior (RRB) Domain Score | Baseline (Day 1) to Day 85 | The FAS-BID included all randomized participants who had received at least 1 dose of study agent at the BID dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. As per study SAP, data for this outcome measure was planned to be collected and analyzed only on the participants who received BID dosing. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 85 in the ABI Mood and Anxiety Domain Score | Baseline (Day 1) to Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 85 in the ABI Challenging Behavior Domain Score | Baseline (Day 1) to Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 85 in the ABI Self-Regulation Domain Score | Baseline (Day 1) to Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 85 in the Aberrant Behavior Checklist (ABC) Subscales Scores | Baseline (Day 1) to Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 71 in the Autism Behavior Inventory-Short Form (ABI-S) Domains Scores | Baseline (Day 1) to Day 71 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 85 in the Autism Behavior Inventory-Clinician Interview (ABI-C) Domains Scores | Baseline (Day 1) to Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 85 in the Clinical Global Impression-Severity (CGI-S) Scale Score | Baseline (Day 1) to Day 85 | The FAS-BID included all randomized participants who had received at least 1 dose of study agent at the BID dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. As per study SAP, data for this outcome measure was planned to be collected and analyzed only on the participants who received BID dosing. | Score on a scale | MEDIAN |
| SECONDARY | Change From Baseline to Day 85 in the Repetitive Behavior Scale - Revised (RBS-R) Subscale Score | Baseline (Day 1) to Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 85 in the Zarit Burden Interview (ZBI) Global Score | Baseline (Day 1) to Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 85 in the Child Adolescent Symptom Inventory - Anxiety (CASI-Anx) Scale Score | Baseline (Day 1) to Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Score on a scale | MEAN |
| PRIMARY | Change From Baseline to Day 85 in the Social Responsiveness Scale 2 (SRS-2) Total T-Score | Baseline (Day 1) to Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | T-score | MEAN |
| SECONDARY | Change From Baseline to Day 85 in the Caregiver Global Impression of Severity (Caregiver GI-S) Scale Score | Baseline (Day 1) to Day 85 | The FAS-BID included all randomized participants who had received at least 1 dose of study agent at the BID dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. As per study SAP, data for this outcome measure was planned to be collected and analyzed only on the participants who received BID dosing. | Score on a scale | MEDIAN |
| SECONDARY | Caregiver Assessment of Treatment: Question 1: Number of Participants With Overall Status (Improvement) of Autism at Day 85 | At Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Caregiver Assessment of Treatment: Question 2: Number of Participants With Improvement in Specific Symptoms During Treatment at Day 85 | At Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure and n (number analyzed): number of participants evaluable at each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Caregiver Assessment of Treatment: Question 3: Number of Participants With Interest in Continuing Treatment at Day 85 | At Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Self Global Impression of Improvement (Self GI-I) Scale Score at Day 85 | At Day 85 | The FAS-BID included all randomized participants who had received at least 1 dose of study agent at the BID dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure. As per study SAP, data for this outcome measure was planned to be collected and analyzed only on the participants who received BID dosing. | Score on a scale | MEAN |
| SECONDARY | Clinical Global Impression-Improvement (CGI-I) Score (Frequency Distribution) at Day 85 | At Day 85 | The FAS analysis set included all randomized participants who had received at least 1 dose of study agent at either dose and had both a baseline and at least 1 postbaseline efficacy assessment. Here, N (number of participants analyzed) signifies participants who were analyzed for this outcome measure and n (number analyzed): number of participants evaluable at each specified category. | Participants | COUNT_OF_PARTICIPANTS |
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.
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