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Assessment of Desogestrel in Ondine Syndrome (RESPIRONDINE)

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ClinicalTrials.gov Identifier: NCT01243697
Recruitment Status : Completed
First Posted : November 18, 2010
Last Update Posted : November 14, 2013
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The congenital central hypoventilation syndrome (CCHS), also known as the Ondine syndrome, is a very rare genetic disorder. In contrast with healthy people, patients do not increase breathing in response to an excess of carbon dioxide (CO2). As a consequence, they do not breath sufficiently, or even stop breathing, during sleep. Their survival depends only on mechanical respiratory assistance, all life long.

We have recently published two cases of recovery of a response to CO2 in patients taking desogestrel as a contraceptive pill. The goal of the study is therefore to assess the hypothesis that desogestrel will restore a respiratory response to CO2 in CCHS patients and allow them to breath sufficiently during sleep without mechanical assistance.

Condition or disease Intervention/treatment Phase
Ondine Syndrome Drug: desogestrel Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Desogestrel for a Pharmacological Recovery of Ventilatory Activity in Congenital Central Hypoventilation Syndrome - Ondine Syndrome
Study Start Date : April 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: desogestrel
Tablets of 75 µg, once daily during 112 days
Drug: desogestrel
Tablets of 75 µg, once daily during 112 days

Primary Outcome Measures :
  1. Increase in the ventilatory response to hypercapnia [ Time Frame: 112 days ]

Secondary Outcome Measures :
  1. Ventilatory response to hypoxia [ Time Frame: 112 days ]
  2. Activation of new cerebral regions in fMRI [ Time Frame: 112 days ]
  3. Weaning from mechanical ventilation during sleep [ Time Frame: 112 days ]

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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243697

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Pitie salpetriere hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: STRAUS Christian, MD, PhD Pitie Salpetriere Hospital (APHP)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01243697    
Other Study ID Numbers: P101001
First Posted: November 18, 2010    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: October 2012
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Additional relevant MeSH terms:
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Sleep Apnea, Central
Pathologic Processes
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptives, Oral, Synthetic
Hormones, Hormone Substitutes, and Hormone Antagonists