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Trial · NCT04623398

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryScore social responsiveness scale12 weeksSeverity of Autistic Symptoms - Social Responsiveness Scale - Total score at 12 weeks.
SecondaryScore social responsiveness scaleBaseline (At randomization) , 4 weeks, 8 weeks, and 16 to 18 weeks after stopping the treatment
Severity of Autistic Symptoms - Social Responsiveness Scale. Evaluate the effect of the treatment on the severity of autistic symptoms. Exploring the improvement of cardinal autistic symptoms (particularly social communication) during the therapeutic trial.
Secondaryscore of autism diagnosis observation scaleBaseline (At randomization) and 12 weeks
Autism Diagnosis Observation Calibrated Severity Score. Evaluate the effect of the treatment on the improvement of cardinal autistic symptoms (particularly social communication) during the therapeutic trial.
SecondaryScore of attention deficit hyperactivity disorderBaseline (At randomization) 4 weeks, 8 weeks, 12 weeks, and 16 to 18 weeks after stopping the treatmentassessment of hyperactivity. Evaluate the effect of the treatment on the improvement of cardinal autistic symptoms (particularly social communication) during the therapeutic trial.
Secondaryscore of child's sleep disorder rating scaleBaseline (At randomization) , 4 weeks, 8 weeks, 12 weeks and 16 to 18 weeks after stopping the treatmentEvaluate the effect of the treatment on Child's Sleep Disorder
SecondaryScore of Dunn Sensory Profile4 weeks, 8 weeks, 12 weeks and 16 to 18 weeks after stopping the treatmentEvaluate the effect of the treatment on the improvement of cardinal autistic symptoms (particularly social communication) during the therapeutic trial.
SecondaryScore of Aberrant Behavior checklist scaleBaseline (At randomization), 4 weeks, 8 weeks and 12 weeksAberrant Behavior Checklist Scale - Social Withdrawal Subscale. Exploring aberrant, stereotyped, repetitive and obsessive behaviours (sub-scores and total score) and co-morbidities
Secondaryscore of global functioningBaseline (At randomization), 4 weeks, 8 weeks, 12 weeks and 16 to 18 weeks after stopping the treatmentClinical Global Improvement - Improvement and Severity Scores. Evaluate the effect of the treatment on the global functioning of patients and the impact on their environment
SecondaryScore of Vineland Adaptive Behavior CompositeBaseline (At randomization) and12 weeksEvaluate the effect of the treatment on the global functioning of patients and the impact on their environment
SecondaryScore of surrounding constraintsBaseline (At randomization), 4 weeks, 8 weeks, 12 weeks and 16 to 18 weeks after stopping the treatmentSurrounding Constraints - Caregiver Strain Index. Evaluate the effect of the treatment on the global functioning of patients and the impact on their environment
Secondaryscore of Columbia Suicide Severity Rating ScaleBaseline (At randomization)and 12 weeksMonitoring suicide risk and suicidal risk via the Columbia Suicide Severity Rating Scale (C-SSRS)

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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