Assessment of Desogestrel in Ondine Syndrome

• Register: ClinicalTrials.gov
• 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
• URL: http://clinicaltrials.gov/show/NCT01243697
• 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

France

Contacts

• 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

Intervention(s)

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]

Weaning from mechanical ventilation during sleep [Time Frame: 112 days]

Ventilatory response to hypoxia [Time Frame: 112 days]

Secondary ID(s)

P101001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors