Trial · NCT04745026
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores | Baseline up to Week 12 | The caregiver-assessed ABC was designed to assess the presence and severity of various problem behaviors commonly observed in individuals diagnosed with intellectual and developmental disability. The checklist contains 5 subscales: Irritability (15 items); Social Withdrawal (16 items); Stereotypic Behavior (7 items); Hyperactivity/Noncompliance (16 items); and Inappropriate Speech (4 items). Each item is scored as 0 (never a problem), 1 (slight problem), 2 (moderately serious problem), or 3 (severe problem). The total score of all items for each subscale range from 0-45 (irritability), 0-48 (social withdrawal and hyperactivity/noncompliance), 0-21 (stereotypic behavior), and 0-12 (inappropriate speech) where higher scores indicate worse clinical outcome. The change from baseline to Week 4, Week 8, and Week 12 is reported with lower scores indicating better clinical outcome. |
| Primary | Change From Baseline in Vineland Adaptive Behavior Scales-3 (VABS-3) Scores | Baseline up to Week 12 | The VABS-3 scales assess what a person does, rather than what he or she can do. The Vineland-3 assesses adaptive behavior in 3 domains: Communication, Daily Living Skills, and Socialization. Each domain is comprised of 3 subdomains: receptive expression and written (communication); personal, domestic and community (daily living skills); Interpersonal relationships, play and leisure and copying skills (socialization). The adaptive behavior composite score is calculated as arithmetic mean of all 3 domain scores. The total score range is 20 to 140, where low scores indicate low (worst) clinical outcome and high scores indicate high (best) clinical outcome. The change from baseline in VABS-3 is being reported with positive values indicating a positive improvement in adaptive behavior. |
| Primary | Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category | Day 85 | The CGI-I is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The clinician is asked: Compared to the patient's condition at admission to the project, how much has the patient changed? This is rated as: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse. Higher scores indicate worse clinical outcome. The number of patients in each CGI-I category is reported. |
| Primary | Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores | Baseline up to Week 12 | The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's experience with patients who have the same diagnosis. The clinician is asked: Considering your total clinical experience with this particular population, how ill is the patient at this time? This is rated as: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill. Higher scores indicate worse outcome. The change from baseline in CGI-S scores is reported and lower mean scores indicate better outcome. |
| Secondary | Number of Participants Reporting Treatment-emergent Adverse Events | Baseline up to Week 12 | A TEAE is one that started, or worsened in severity or seriousness, following the first dose of IMP. AEs were coded according to the Medical Dictionary for Regulatory Activities v24.0 dictionary. |
| Secondary | Mean Change From Baseline in Hematology Clinical Laboratory Levels | Baseline up to Week 9 (end of taper/withdrawal) | |
| Secondary | Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels | Baseline up to Week 9 (end of taper/withdrawal) | |
| Secondary | Mean Change From Baseline in Hemoglobin Levels | Week 9 (end of taper/withdrawal) | |
| Secondary | Mean Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Levels | Week 9 (end of taper/withdrawal) | |
| Secondary | Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Levels | Week 9 (end of taper/withdrawal) | |
| Secondary | Number of Patients With Clinically Significant Vital Sign Values | Post-baseline up to 12 weeks | |
| Secondary | Number of Patients With Clinically Significant Physical Examination Procedure Findings | Baseline up to Day 85 post-baseline | Number of patients with abnormal physical exam findings are reported. |
| Secondary | Number of Patients With Clinically Significant 12-lead Electrocardiogram Findings | Baseline up to Day 85 post-baseline | |
| Secondary | Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline up to Day 92 | C-SSRS rating scale results since last visit is reported. The presence/absence of any suicidal ideation or behavior is scored based on yes/no responses. The overall number of participants reporting suicidal ideation or behavior is being reported. |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04745026/registered