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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03114371 |
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Date of registration:
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10/03/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Oxytocin Intranasal Administrations in Children With Prader-Willi Syndrome Aged From 3 to 12 Years
Oxyjeune |
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Scientific title:
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Effects of Intranasal Administrations of Oxytocin on Behavioural Troubles, Hyperphagia and Social Skills in Children With Prader-Willi Syndrome Aged From 3 to 12 Years. |
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Date of first enrolment:
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November 28, 2016 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03114371 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Sophie ÇABAL-BERTHOUMIEU, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre de référence du syndrome de Prader-Willi, Hôpital des Enfants |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patient with a complete genetic diagnosis of Prader-Willi syndrome
- patient treated by growth hormone for at least 1 year
- patient naïve for oxytocin for at least 5 years
Exclusion Criteria:
- patient who do not accept intranasal administrations (major behavioural trouble)
- patient with hepatic insufficiency : serum transaminases (SGOT, SGPT) higher than 3
times normal values for age
- patient with renal insufficiency : serum creatinine higher than 3 times normal values
for age
- patient with an antecedent of abnormal electrocardiogram
- patient with arterial hypertension or hypotension
- patient with type 1 or 2 diabetes
Age minimum:
3 Years
Age maximum:
12 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Prader-Willi Syndrome
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Intervention(s)
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Drug: Placebo
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Drug: Oxytocin
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Primary Outcome(s)
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Evolution of behavioural troubles evaluated by the global score of Child Behavior Check List Questionnaire after 12 weeks of oxytocin/placebo treatment.
[Time Frame: Week 12]
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Secondary Outcome(s)
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Evaluation of psychopathology after 12 weeks of oxytocin/placebo treatment.
[Time Frame: Week 12]
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Evaluation of auto- and hetero-aggressive after 12 weeks of oxytocin/placebo treatment.
[Time Frame: Week 12]
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Evaluation of metabolic brain resting state after 12 weeks of oxytocin/placebo treatment, for patients aged from 7 to 12 years at inclusion.
[Time Frame: Week 12]
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Evaluation of global clinical status after 12 weeks of oxytocin/placebo treatment.
[Time Frame: Weeks 12]
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Evaluation of attentional abilities after 12 weeks of oxytocin/placebo treatment, for patients aged from 7 to 12 years at inclusion.
[Time Frame: Week 12]
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Evaluation of acyl and desacyl ghrelin plasma levels after 12 weeks of oxytocin/placebo treatment.
[Time Frame: Week 12]
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Evaluation of social skills after 12 weeks of oxytocin/placebo treatment.
[Time Frame: Week 12]
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Evaluation of hyperphagia after 12 weeks of oxytocin/placebo treatment.
[Time Frame: Week 12]
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Secondary ID(s)
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2016-003273-18
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15 7837 03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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