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Trial · NCT01730209

Registered outcomes14

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

ListOutcomeTime frameDescription
PrimaryCognitive ability measured by IQ12 monthsAssessed by Wechsler scales: Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III NL) and Wechsler Intelligence Scale for Children (WISC-III-NL)
SecondaryAutistic features12 MonthsAssessed by Autism Diagnostic Observation Schedule (ADOS)
SecondarySocial and communicational skills12 MonthsAssessed by social responsiveness scale (SRS) and Dutch Children's Communication Checklist (CCC-2-NL) questionnaires
SecondaryWorking memory and attention, information processing6 and 12 MonthsAssessed by Cambridge Neuropsychological Test Automated Battery (CANTAB)
SecondaryVisual-motor integration12 MonthsAssessed by BEERY Visual-Motor Integration (BEERY VMI), grooved pegboard
SecondaryChild behavior12 MonthsAssessed by Child Behavior Checklist (CBCL) and Teacher's Report Form (TRF) questionnaires
SecondaryExecutive functioning12 MonthsAssessed by Behavior Rating Inventory of Executive Functioning (BRIEF) questionnaire Dutch version
SecondarySleeping problems12 MonthsAssessed by Sleep Disturbance Scale for Children (SDSC) questionnaire
SecondaryChild health12 MonthsAssessed by Child Health Questionnaire Parent Form (CHQ-PF50) questionnaire
SecondarySensory related difficulties12 MonthsAssessed by Short Sensory Profile (SSP) questionnaire
SecondaryEpilepsy12 MonthsComparison of epilepsy frequency during month previous to study start and last month of trial participation. EEG abnormalities
OtherSchool level12 MonthsAssessed by the school CITO (centraal instituut voor toetsontwikkeling) scores or reading and arithmetic scores
OtherPharmacokinetics12 MonthsAssessed by measuring trough levels of everolimus
OtherSafety12 MonthsLevels of and abnormalities in blood control values

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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