Trial record 4 of 4 for:    "Congenital central hypoventilation syndrome"

Assessment of Desogestrel in Ondine Syndrome (RESPIRONDINE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01243697
First received: November 17, 2010
Last updated: November 13, 2013
Last verified: October 2012
  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:


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 ]

Enrollment: 6
Study Start Date: April 2011
Study Completion Date: September 2013
Primary Completion Date: September 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

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: November 13, 2013
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 22, 2014