Trial · NCT03776656
Evaluation of a Treatment With Allopurinol in Adenylosuccinate Lyase Deficiency
NCT03776656, Phase 2, Completed, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Evaluation of a Treatment With Allopurinol in Adenylosuccinate Lyase Deficiency. Trials, record NCT03776656. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03776656
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of a Treatment With Allopurinol in Adenylosuccinate Lyase Deficiency
- NCT number
- NCT03776656
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Adenylosuccinate Lyase Deficiency
- Interventions
- Allopurinol
- First posted
- 2018-12-17
- Last updated
- 2026-03-04
- Other registries' IDs
- eudract:2017-002155-28
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41053929 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03776656
GET https://conductscience.org/api/trials/v1/NCT03776656/registered