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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
Sponsor:
Information provided by (Responsible Party):

Study Description
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

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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
Primary Completion Date : September 2013
Study Completion Date : September 2013


Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

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


Locations
France
Pitie salpetriere hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: STRAUS Christian, MD, PhD Pitie Salpetriere Hospital (APHP)
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01243697     History of Changes
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:
Desogestrel
Chemosensitivity

Additional relevant MeSH terms:
Syndrome
Sleep Apnea, Central
Disease
Pathologic Processes
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Desogestrel
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists