Oxygen treatment for cluster headache attacks at different flow rates. A double-blind, randomized, cross-over design study.

• Conditions: To study whether there is a difference in treatment effect between oxygen at flow rates of 7 L/min versus 12 L/min in the acute treatment of cluster headache attacks.; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-003648-59-NL
• Lead Sponsor: Dept. of Neurology, Atrium Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-10
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All newly diagnosed cluster headache patients of at least 18 years of age and known cluster headache patients of at least 18 years of age who are naïve to oxygen treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- All patients who used oxygen in the past.
- Pregnancy or lactation.
- COPD and other contraindications for oxygen therapy, as determined by the patients’ physicians.
- Secondary cluster headache. Patients might be included before imaging is conducted. If so, they will be excluded afterwards when they are diagnosed as secondary cluster headache.
- Other primary or secondary headache diagnoses or other distracting painful conditions which could interfere with the patient’s pain perception.
- Incapacitation to understand and sign for informed consent.
- Patients living outside a designated insurance zone, as costs of the adapted oxygen tanks will not be covered elsewhere.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified