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Desogestrel for Ventilatory Recovery in CCHS
NCT01243697Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2011
- Primary completion
- Sep 2013
- Countries
- 1
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Modality
- Small Molecules
- Drugs
- desogestrel
- Conditions
- congenital central hypoventilation syndrome (CCHS)
01
Overview
Phase 3, open-label, single-arm trial of desogestrel in congenital central hypoventilation syndrome (CCHS), sponsored by Assistance publique - Hôpitaux de Paris. Primary endpoint: Increase in the ventilatory response to hypercapnia at 112 days. Started Apr 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Desogestrel
Desogestrel 75 µg daily
03
Who it enrols
Pubescent female patients with Ondine syndrome (CCHS). Patients must stop other hormonal contraceptives.
04
Endpoints
Primary
Increase in the ventilatory response to hypercapnia
Secondary
Ventilatory response to hypoxia
Activation of new cerebral regions in fMRI
Weaning from mechanical ventilation during sleep
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