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Baclofen and Hypoxia-induced Periodic Ventilation (PERIODIBAC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01095679
First received: March 29, 2010
Last updated: October 30, 2012
Last verified: December 2009
  Purpose

Periodic ventilation that includes CHEYNE Stokes ventilation is a pathological pattern characterized by alternating periods of hyperpneas and apnea-hypopneas. It occurs generally during sleep, at high altitude and in hypoxic conditions in healthy subjects, and in some diseases like congestive heart failure. One study conducted on an animal model suggested that baclofen, a drug already used against spasticity in humans, could also be effective against periodic ventilation. The goal of the study is therefore to assess this hypothesis on hypoxia-induced periodic ventilation in healthy subjects during sleep.


Condition Intervention Phase
CHEYNE Stokes Respiration
Drug: Baclofen
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Effect of the GABA-B Receptor Agonist, Baclofen, on Hypoxia-induced Periodic Ventilation, in Healthy Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Decrease in the coefficient of variation of the period of the ventilatory cycle [ Time Frame: During the second and the third session in hypoxia ] [ Designated as safety issue: No ]
    The primary outcome will be the decrease in the coefficient of variation of the period of the ventilatory cycle. The measures will be taken during the second and the third session in hypoxia. This means, for each subject, after having taken either placebo or 60 mg per day of Baclofen for 3-5 days.


Secondary Outcome Measures:
  • Decrease in the coefficient of variation of the tidal volume [ Time Frame: During the second and the third session in hypoxia ] [ Designated as safety issue: No ]
    Decrease in the coefficient of variation of the tidal volume. The measures will be taken during the second and the third session in hypoxia. This means, for each subject, after having taken either placebo or 60 mg per day of Baclofen for 3-5 days.

  • Decrease in the coefficient of variation of the end tidal CO2 pressure [ Time Frame: During the second and the third session in hypoxia ] [ Designated as safety issue: No ]
    Decrease in the coefficient of variation of the end tidal CO2 pressure. The measures will be taken during the second and the third session in hypoxia. This means, for each subject, after having taken either placebo or 60 mg per day of Baclofen for 3-5 days.

  • Decrease in the number of frequency compounds of the ventilatory flow [ Time Frame: During the second and the third session in hypoxia ] [ Designated as safety issue: No ]
    Decrease in the number of frequency compounds of the ventilatory flow. The measures will be taken during the second and the third session in hypoxia. This means, for each subject, after having taken either placebo or 60 mg per day of Baclofen for 3-5 days.

  • Decrease in the apnea-hypopnea index [ Time Frame: During the second and the third session in hypoxia ] [ Designated as safety issue: No ]
    Decrease in the apnea-hypopnea index. The measures will be taken during the second and the third session in hypoxia. This means, for each subject, after having taken either placebo or 60 mg per day of Baclofen for 3-5 days.

  • Decrease in the sleep fragmentation index [ Time Frame: During the second and the third session in hypoxia ] [ Designated as safety issue: No ]
    Decrease in the sleep fragmentation index. The measures will be taken during the second and the third session in hypoxia. This means, for each subject, after having taken either placebo or 60 mg per day of Baclofen for 3-5 days.

  • Change in the non-linea dynamics of the ventilatory flow [ Time Frame: During the second and the third session in hypoxia ] [ Designated as safety issue: No ]
    Change in the non-linea dynamics of the ventilatory flow. The measures will be taken during the second and the third session in hypoxia. This means, for each subject, after having taken either placebo or 60 mg per day of Baclofen for 3-5 days.


Enrollment: 53
Study Start Date: March 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baclofen Drug: Baclofen
Breaking tablets of 10 mg of baclofen. Dosage and frequency : 5 mg 3 times a day for 3 days, then 10 mg 3 times a day for 3 days, then 15 mg 3 times a day for 3 days, then 20 mg 3 times a day for 3-5 days, then 15 mg 3 times a day for 1 day, then 10 mg 3 times a day for one day, then 5 mg 3 times a day for one day.
Other Name: Baclofen
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Breaking tablets of 10 mg of placebo. Dosage and frequency : 5 mg 3 times a day for 3 days, then 10 mg 3 times a day for 3 days, then 15 mg 3 times a day for 3 days, then 20 mg 3 times a day for 3-5 days, then 15 mg 3 times a day for 1 day, then 10 mg 3 times a day for one day, then 5 mg 3 times a day for one day.
Other Name: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult
  • Male
  • Body mass index between 20 and 30 kg/m2
  • Healthy (no known disease)
  • No regular treatment except first grade antalgic drugs (e. g. ACETAMINOFEN)
  • Written consent to participate in the study
  • Health insurance

Exclusion Criteria:

  • Intolerance to baclofen
  • Tobacco, alcohol or drug consumption
  • Past history of possible acute mountain sickness
  • Regular treatment for any disease
  • Claustrophobia
  • Coronary disease
  • Hypertension
  • Cardiac failure
  • Cardiac rhythm abnormalities
  • Pulmonary hypertension
  • Any pulmonary artery abnormality
  • Any cardiac disease
  • Past history of cerebral ischemia
  • Past history of psychiatric disorder
  • Any respiratory disease (including asthma)
  • Leg arteriopathy
  • Sickle cell anemia
  • Renal insufficiency
  • Migraine
  • Diabetes
  • Obesity
  • Thalassemia
  • Scoliosis
  • Past history of phlebitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095679

Locations
France
Pitié-Salpêtrière Hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Christian Straus, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01095679     History of Changes
Other Study ID Numbers: P090207
Study First Received: March 29, 2010
Last Updated: October 30, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
CHEYNE Stokes respiration
Periodic ventilation
baclofen
hypoxia
healthy subject

Additional relevant MeSH terms:
Cheyne-Stokes Respiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
GABA-B Receptor Agonists
GABA Agents
GABA Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014