Trial · NCT03682978
Arbaclofen in Children and Adolescents With ASD
NCT03682978, Phase 2, Completed, Celso Arango, MD, PhD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Arbaclofen in Children and Adolescents With ASD. Trials, record NCT03682978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03682978
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Arbaclofen in Children and Adolescents With ASD
- NCT number
- NCT03682978
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 124 participants, actual
- Lead sponsor
- Celso Arango, MD, PhD
- Conditions
- Autism Spectrum Disorder
- Interventions
- Arbaclofen, Placebo
- First posted
- 2018-09-25
- Last updated
- 2023-02-08
- Other registries' IDs
- eudract:2018-000942-21
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effect of Arbaclofen vs. placebo on social function | Week 0 + Week 16 | Vineland-3 (socialization domain): The Vineland Adaptive Behavior Scales, Third Edition is designed to assess the personal and social functioning of handicapped and non-handicapped persons. It is a gold standard for the assessment of adaptive functioning. The Socialization domain is one of the 4 adaptive domains assessed by the comprehensive interview form. The other 3 adaptive domains are communication, daily living skills and motor skills. The Socialization domain has 3 subdomains: interpersonal relations, play and leisure and coping skills. |
| Secondary | Effect of Arbaclofen vs. placebo on measures of global function | Week 2 + Week 4 + Week 6 + Week 8 + Week 12 + Week 16 + Week 18 | CGI-I: Clinical Global Impression - Improvement Scale is used to determine the patient's improvement in response to treatment. |
| Secondary | Effect of Arbaclofen vs. placebo on measures of global function | Week 0 + Week 2 + Week 4 + Week 6 + Week 8 + Week 12 + Week 16 + Week 18 | CGI-S: The Clinical Global Impression - Severity Scale is used to assess the impairment of neurobehavioral function in study subjects. |
| Secondary | Effect of Arbaclofen vs. placebo on other adaptive domains | Week 0 + Week 16 | Vineland-3 (other adaptive domains): The Vineland Adaptive Behavior Scales, Third Edition, other adaptive domains: communication, daily living skills and motor skills. |
| Secondary | Effect of Arbaclofen on measures of social abilities and responsiveness | Week -3 | ADOS-2: The Autism Diagnostic Observation Schedule, Version 2, will be used to assess autistic symptomatology.The ADOS-2 is a standardized protocol for the observation of social and communicative behaviour in children, adolescents, and adults who are suspected of having an ASD. |
| Secondary | Effect of Arbaclofen on measures of social abilities and responsiveness through BOSCC | Week 0 + Week 16 | BOSCC: The Brief Observation of Social Communication Change will be used to to sensitively measure change of core autistic symptoms by observation of a semi-structured social interaction between a child and an examiner. |
| Secondary | Effect of Arbaclofen on measures of social abilities and responsiveness through SRS-2-P | Week 0 + Week 16 | SRS-2-P: The Social Responsiveness Scale (parent version) measures the severity of social impairment in ASD. |
| Secondary | Effect of Arbaclofen on measures of social abilities and responsiveness through SRS-2-T | Week 0 + Week 16 | SRS-2-T: The Social Responsiveness Scale (teacher version) measures the severity of social impairment in ASD. |
| Secondary | Effect of Arbaclofen on measures of problem behaviours | Week 0 + Week 4 + Week 8 + Week 12 + Week 16 | ABC-C: This is the community version of the original residential version of the Aberrant Behaviour Checklist. It is designed to objectively identify five behaviour subscales through observation by the primary caregiver: irritability, lethargy, stereotypy, hyperactivity, and inappropriate speech. |
| Secondary | Effect of Arbaclofen on measures of problem behaviours | Week 0 + Week 16 | CBCL: Child Behaviour Checklist is a caregiver report form identifying problem behaviour in children. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT03682978
GET https://conductscience.org/api/trials/v1/NCT03682978/registered?page=2