Trial · NCT03682978
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| 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. |
| Secondary | Effect of Arbaclofen on other measures of core symptoms | Week 0 + Week 4 + Week 8 + Week 12 + Week 16 | AIM: The Autism Impact Measure is designed to measure change in the core symptoms of autism. |
| Secondary | Safety and tolerability of Arbaclofen in children and adolescents with ASD as assessed with the SMURF | Week 0 + Week 2 + Week 4 + Week 6 + Week 8 + Week 12 + Week 16 + Week 18 | SMURF: Safety Monitoring Uniform Research Form. |
| Secondary | Safety and tolerability of Arbaclofen in children and adolescents with ASD as assessed with the ESS-CHAD | Week 0 + Week 2 + Week 4 + Week 6 + Week 8 + Week 12 + Week 16 + Week 18 | ESS-CHAD: The Epworth Sleepiness Scale for Children and Adolescents will be employed to evaluate sedation. |
| Secondary | Safety and tolerability of Arbaclofen in children and adolescents with ASD as assessed with the C-SSRS | Week 0 + Week 2 + Week 4 + Week 6 + Week 8 + Week 12 + Week 16 + Week 18 | C-SSRS: The Columbia Suicide Severity Rating Scale is used to measure suicidality. |
| Secondary | Safety and tolerability of Arbaclofen in children and adolescents with ASD as assessed with a pulse rate measurement | Week -3 + Week 0 + Week 2 + Week 4 + Week 6 + Week 8 + Week 12 + Week 16 + Week 18 | Vital signs: pulse |
| Secondary | Safety and tolerability of Arbaclofen in children and adolescents with ASD as assessed with a body temperature measurement | Week -3 + Week 0 + Week 2 + Week 4 + Week 6 + Week 8 + Week 12 + Week 16 + Week 18 | Vital signs: body temperature |
| Secondary | Safety and tolerability of Arbaclofen in children and adolescents with ASD as assessed with a blood pressure measurement | Week -3 + Week 0 + Week 2 + Week 4 + Week 6 + Week 8 + Week 12 + Week 16 + Week 18 | Vital signs: blood pressure |
| Secondary | Safety and tolerability of Arbaclofen in children and adolescents with ASD as assessed by measuring weight | Week -3 + Week 0 + Week 2 + Week 4 + Week 6 + Week 8 + Week 12 + Week 16 + Week 18 | Weight: Weight (in kg) will be assessed with all outer wear and shoes removed. |
| Secondary | Safety and tolerability of Arbaclofen in children and adolescents with ASD as assessed by measuring height | Week -3 + Week 0 + Week 2 + Week 4 + Week 6 + Week 8 + Week 12 + Week 16 + Week 18 | Height: Height (in cm) will be assessed with all outer wear and shoes removed. |
| Secondary | Safety and tolerability of Arbaclofen in children and adolescents with ASD as assessed with the Tanner scale | Week -3 + Week 0 + Week 2 + Week 4 + Week 6 + Week 8 + Week 12 + Week 16 + Week 18 | Tanner stage |
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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