Baclofen and Hypoxia-induced Periodic Ventilation

NCT01095679 | Completed Phase 1 DMC

• 1 other identifier: P090207
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CHEYNE Stokes Respiration

Keywords

CHEYNE Stokes respiration; Periodic ventilation; baclofen; hypoxia; healthy subject

Outcome Measures

Primary Outcomes (1)

• Decrease in the coefficient of variation of the period of the ventilatory cycle

  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.

  During the second and the third session in hypoxia

Secondary Outcomes (6)

• Decrease in the coefficient of variation of the tidal volume

  During the second and the third session in hypoxia

• Decrease in the coefficient of variation of the end tidal CO2 pressure

  During the second and the third session in hypoxia

• Decrease in the number of frequency compounds of the ventilatory flow

  During the second and the third session in hypoxia

• Decrease in the apnea-hypopnea index

  During the second and the third session in hypoxia

• Decrease in the sleep fragmentation index

  During the second and the third session in hypoxia

Study Arms (2)

Baclofen

EXPERIMENTAL

Drug: Baclofen

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Baclofen DRUG

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.

Baclofen

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Cheyne-Stokes Respiration; Hypoxia

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Christian Straus, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: March 30, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 31, 2012

Record last verified: 2009-12

Locations

FR (1)