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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.
Last refreshed on: 19 February 2015
Main ID:  NCT01243697
Date of registration: 17/11/2010
Prospective Registration: Yes
Primary sponsor: Assistance Publique - Hôpitaux de Paris
Public title: Assessment of Desogestrel in Ondine Syndrome RESPIRONDINE
Scientific title: Assessment of Desogestrel for a Pharmacological Recovery of Ventilatory Activity in Congenital Central Hypoventilation Syndrome - Ondine Syndrome
Date of first enrolment: April 2011
Target sample size: 6
Recruitment status: Completed
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2/Phase 3
Countries of recruitment
Name:     STRAUS Christian, MD, PhD
Affiliation:  Pitie Salpetriere Hospital (APHP)
Key inclusion & exclusion criteria

Inclusion criteria :

- Ondine syndrome

- Pubescent female

Exclusion criteria :

- Contra-indications to a treatment with desogestrel.

- Other treatment with estrogens or progestin that cannot be stopped.

Age minimum: 10 Years
Age maximum: 60 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Ondine Syndrome
Drug: desogestrel
Primary Outcome(s)
Increase in the ventilatory response to hypercapnia [Time Frame: 112 days]
Secondary Outcome(s)
Activation of new cerebral regions in fMRI [Time Frame: 112 days]
Ventilatory response to hypoxia [Time Frame: 112 days]
Weaning from mechanical ventilation during sleep [Time Frame: 112 days]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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