Cluster Headache Attacks Clinical Trial
| Verified date | October 2015 |
| Source | Danish Headache Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: GCP-enheden for Region Hovedstaden |
| Study type | Interventional |
This study will investigate the possible difference in treatment effect between three different oxygen delivery systems in the acute treatment of cluster headaches.
| Status | Completed |
| Enrollment | 57 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - episodic cluster headache - regular occurance of attacks and cluster for 2 years - 2-8 attacks / day - cluster periods of over 14 days - duration of current cluster period max 14 days - ability to differentiate between attacks of CH and other forms of headache Exclusion Criteria: - Changes in prophylactic treatment a week before trial - pregnancy or breastfeeding women - serious somatic or psychiatric disease - COLD - chronic or primary or secondary headache > 14 days / month other than CH - alcohol abuse |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Danish Headache Center | Glostrup |
| Lead Sponsor | Collaborator |
|---|---|
| Mads Barløse |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy | Pain relief after 15 minutes of treatment | 15 minutes | No |
| Secondary | Mask preference | subject mask preference | 2 days | No |