Status:
UNKNOWN
PACAP-38 Infusion in Patients With Cluster Headache
Lead Sponsor:
Danish Headache Center
Conditions:
Cluster Headache
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
A randomized, double-blinded, two-way crossover study investigating the headache inducing capabilities of PACAP-38 in patients with cluster headache. Forty-five patients (15 episodic patients in clust...
Eligibility Criteria
Inclusion
- Episodic or chronic cluster headache according to international classification of headache disorders
- Age 18-65 years
- Weight 50-100 kg
- If women of childbearing potential, then must use safe contraceptives
Exclusion
- Episodic tension-type headache \> 15 days per month
- Other primary headache disorders, except tension-type headache \< 5 days per month
- Episodic cluster headache patients outside cluster must be completely headache free a minimum of 8 hours prior to experiment
- Episodic cluster headache patients in cluster and chronic cluster headache patients must be completely headache free a minimum of 4 hours prior to experiment
- Current or recent use (30 days) of injected or oral corticosteroids
- Pregnant or lactating women
- A history or clinical signs of hypertension (BP \> 150mmHg systolic / 100mmHg diastolic)
- A history or clinical signs of hypotension (BP \<90 mmHg systolic / 50mmHg diastolic)
- A history of cardiovascular or cerebrovascular disease
- A history of psychiatric disease or substance abuse
- A medical history or clinical signs of disease that according to investigator would preclude participation in the study
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 5 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03814226
Start Date
January 1 2018
End Date
May 5 2020
Last Update
January 23 2019
Active Locations (1)
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1
Danish Headache Center
Glostrup Municipality, Denmark, 2620