Trial · NCT03715166
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Childhood Autism Rating Scale, Second Edition (CARS2) total raw score | Change from baseline to 6 month | Efficacy criterion The CARS2 is a 15 item rated instrument. The rating values given for the 15 areas are summed to produce a Total score. |
| Secondary | Social Responsiveness Scale, Second Edition (SRS-2) total raw score | Change from baseline to 6 month | Efficacy criterion 65 items scale measuring symptoms associated with autism |
| Secondary | Clinical Global Impression - Global Improvement (CGI-I) score | At 6 months | Efficacy criterion Scale which assesses the severity of the illness and the global improvement of the patient under study treatment |
| Secondary | Vineland Adaptative Behaviour Sales, Second Edition (VABS II) subscores | Change from baseline to 6 month | Efficacy criterion Scale designated to measure adaptative behaviour |
| Secondary | Adverse events and Paediatric Adverse Event Rating Scale (PAERS) | On average of 52 weeks | Safety criterion Inventory report used to identify signs/symptoms experienced by the patient since the study treatment initiation. |
| Secondary | Abnormalities in 12-leads electrocardiogram (ECG) parameters | selection visit/Week004/Week008/Week012/Week 026/Week030/Week034/Week038/Week052 | Safety criterion |
| Secondary | Renal ultrasound | selection visit/Week026/Week052 | Safety criterion Assessment of the renal function |
| Secondary | the Columbia Suicide Severity Rating Scale Children's version (C-SSRS-C) | Week000/Week012/Week026/Week038/Week052 | Scale which assesses suicidal ideation and suicidal behaviour |
| Secondary | Tanner stage | Week000/Week026/Week052 | Safety criterion Assessment of Pubertal development |
| Secondary | Acceptability and palatability questionnaire | Week026 | Acceptability and palatability criterion Assessment of the ease of use to use the dosing device |
| Secondary | Paediatric Quality of Life Inventory (PedsQL) questionnaire | Week000/Week004/Week012/Week026/Week030/Week038/Week052 | Quality of Life criterion Assessment of parent/legal representative perception of patient health related quality of life |
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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GET https://conductscience.org/api/trials/v1/NCT03715166/registered