Trial · NCT03776656
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measurement of adaptive functional improvement : composite total score for Vineland II adaptive behaviour Scale | 12 months | to assess Efficacy of Allopurinol (Zyloric)® treatment from Baseline : For each scale : Mean : 100 SD : 15 * Adaptive behaviour composite : Range 20 to 180 -Domains scores : Range 20 to 140 -Communication : Range 20 to 140 -Daily living skills : Range 20 to 140 -Socialization : 20 to 140 -Motor skills : 20 to 140 For each scale values are considered to be better or worse outcome :High 130 to 140 -Moderately High 115 to 129 -Adequate 86 to 114 -Moderately Low 71 to 85 -Low 20 to 70 Total score is obtained by summing the subdomains scores |
| Secondary | Evolution of the Scores of different subdomains Vineland II scale from baseline | at 0, 6 months and 12 months | Clinical evolution for developmental and cognitive assessment |
| Secondary | Evolution of the Psycho-Educative Profile (PEP III/R) from baseline | at 0, 12 months | Clinical evolution for developmental and cognitive assessment |
| Secondary | Evolution of the Score ADI-R (Autism Diagnostic Interview-Revised) from baseline | at 0, 12 months | Clinical evaluation for autistic symptoms : scale ranges : * A : Social interactions: 0 to 30 (significative if \>10) * B : Communication : 0 to 26 (significative if \> 7 or 8) * C : Repetitive and restricted interests : 0 to 16 (significative if \>3) * D : Developmental abnormality present before 36 months : 0 to 5 (significative if \>1) better score : 0 (non autistic) - worse score : the higher score is the worst |
| Secondary | Evolution of the Score ADOS-2 (Autism Diagnostic Observation Schedule 2) from baseline | at 0, 12 months | Clinical evaluation for autistic symptoms. Scale ranges : * A : Socialization : social interactions and communication : 0 to 20 (social interactions : 0 to 6 -communication : 0 to 14) * B : Restricted and repetitive interests : 0 to 8 * Total : A+B : 0 to 28 Autism : total score\>12 - Autism Spectrum Disorder : total score \>8 Better score : 0 - Worse score : the highest score is the worst |
| Secondary | Evolution of the Score on Conners hyperactivity Scale | at 0, 6 months and 12 months | Clinical evolution for behavioral disorders and adaptive functioning Conners Scale for Parents : \- Subscales : Behavioural difficulties (items 2-8-14-19-20-27-35-39) : 0 to 24 Learning difficulties (items 10-25-31-37) : 0 to 12 Somatisation (items 32-41-43-44) : 0 to 12 Impulsivity, hyperactivity (items 4-5-11-13): 0 to 12 Anxiety (items 12-16-24-47): 0 to 12 -Hyperactivity index : sum of the items (4-7-11-13-14-25-31-33-37-38) divided by 10 : 0 to 3 Conners Scale for teachers : \- Subscales : Behavioural difficulties (items 4-5-6-10-11-12-23-27) : 0 to 24 Impulsivity, hyperactivity (items 1-2-3-8-14-15-16) : 0 to 21 Inattention, passivity (items 7-9-18-20-21-22-26-28) : 0 to 24 -Hyperactivity index (sum of the items 1-5-7-8-10-11-14-15-21-26 divided by 10) : 0 to 3 Better score : 0 - Worse score : the highest score is the worst -Hyperactivity index : Significative if\> 1,5 |
| Secondary | Evolution of the Score on ABC scale (Aberrant Behaviour Checklist) | at 0, 6 months and 12 months | Clinical evolution for behavioral disorders and adaptive functioning scale ranges : * Irritability : 0 to 45 * Lethargy : 0 to 48 * Stereotypy : 0 to 21 * Hyperactivity : 0 to 48 * Inappropriate speech : 0 to 12 Better score : 0 -Worse score : the highest score is the worst on each scale- there is no total score |
| Secondary | Evolution of SAICAr levels in the urine | at 0, 6 months and 12 months | Evolution of the quantity of urinary metabolites from Baseline |
| Secondary | Evolution of S-Ado levels in the urine | at 0, 6 months and 12 months | Evolution of the quantity of urinary metabolites from Baseline |
| Secondary | Evolution of SAICAr levels in the blood | at 0, 6 months and 12 months | Evolution of the quantity of plasma metabolites from Baseline |
| Secondary | Evolution of S-Ado levels in the blood | at 0, 6 months and 12 months | Evolution of the quantity of plasma metabolites from Baseline |
| Secondary | Evolution of the number of seizures from Baseline for epileptic patients | at 0 and 12 months | at baseline, performing neurological examinations and interrogation |
| Secondary | Evolution of antiepileptic treatments from Baseline for epileptic patients | at 0 and 12 months | at baseline, performing neurological examinations and interrogation |
| Secondary | Evolution of electroencephalogram tracing from Baseline for epileptic patients | at 0 and 12 months | normal/abnormal |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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