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Trial record 4 of 4 for:    "Congenital central hypoventilation syndrome"
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Assessment of Desogestrel in Ondine Syndrome (RESPIRONDINE)

This study is currently recruiting participants.
Verified October 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01243697
First received: November 17, 2010
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Ondine Syndrome
 Drug: desogestrel
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Desogestrel for a Pharmacological Recovery of Ventilatory Activity in Congenital Central Hypoventilation Syndrome - Ondine Syndrome

Resource links provided by NLM:

Drug Information available for: Desogestrel
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Increase in the ventilatory response to hypercapnia [ Time Frame: 112 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ventilatory response to hypoxia [ Time Frame: 112 days ] [ Designated as safety issue: No ]
  • Activation of new cerebral regions in fMRI [ Time Frame: 112 days ] [ Designated as safety issue: No ]
  • Weaning from mechanical ventilation during sleep [ Time Frame: 112 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: April 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: desogestrel
Tablets of 75 µg, once daily during 112 days
 Drug: desogestrel
Tablets of 75 µg, once daily during 112 days
Other Name: desogestrel

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243697

Locations
France
Pitie salpetriere hospital Recruiting
Paris, France, 75013
Contact: STRAUS Christian, MD, PhD     +33 1 42 17 85 78     christian.straus@psl.aphp.fr    
Principal Investigator: STRAUS Christian, MD, PhD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: STRAUS Christian, MD, PhD Pitie Salpetriere Hospital (APHP)
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional 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
Study First Received: November 17, 2010
Last Updated: October 30, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Desogestrel
Chemosensitivity

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

ClinicalTrials.gov processed this record on May 22, 2013