No registrations found.
ID
Source
Brief title
Health condition
Migraine
CGRP
Propranolol
Iontophoresis/Iontoforese
Capsaicin/Capsaïcine
Sponsors and support
Internist, Vascular Medicine.
Erasmus Medical Center Rotterdam
‘s Gravendijkwal 230, 3015GC Rotterdam, The Netherlands
Telephone number : 0031 010 7034220
Fax number : 0031 010 7034937
E-mail: a.vandenmeiracker@erasmusmc.nl
Intervention
Outcome measures
Primary outcome
Changes in dermal blood flow response to capsaicin application and saline iontophoresis, after propranolol administration.
Secondary outcome
Blood pressure changes after propranolol use.
Background summary
Migraine is one of the top 10 most disabling diseases. Propranolol is a nonselective β-blocker that is primarily used to treat hypertension and there is high-quality evidence that propranolol is also an effective prophylactic drug for migraine headaches. The mechanism of action of propranolol is still unknown. We hope to determine the mechanism by measuring with a laser Doppler scanner the increase in dermal blood flow after stimulation of the afferent nerves of the trigeminal nerve on the forehead. The trigeminal nerve also innervates the dura mater, where the migraine is thought to have its origin. We hypothesized that the propranolol will inhibit the rise of dermal blood flow caused by capsaicin application and saline iontophoresis. This will provide more insight in the action of propranolol, resulting in a better understanding of the pathophysiology of migraine and also in its prophylactic treatment.
Study objective
The administration of propranolol will inhibit the increase in dermal blood flow (DBF) induced by capsaicin application.
Study design
The volunteers will come twice to Erasmus MC. Each appointment will last an estimated of 150 minutes.
Intervention
The volunteers will need to take a tablet of Propranolol 80mg (which is the normal therapeutic dose)
J. Langendonk
‘s Gravendijkwal 230
Rotterdam 3015 GC
The Netherlands
Telephone number : 0031 010 7040115
J. Langendonk
‘s Gravendijkwal 230
Rotterdam 3015 GC
The Netherlands
Telephone number : 0031 010 7040115
Inclusion criteria
• Age between 18 and 64 years
• Male or female
• Females should use an oral contraceptive pill
• Non-smoking for > 6 months
• Body mass index between 19 and 30 kg/m2
• Capable and willing to give informed consent
• General good health, based on medical history and physical examination
Exclusion criteria
• History of cardiovascular disease
• Blood pressure <110/70 (supine)
• Heart rate <60 bpm
• Perimenopausal status of females
• Any serious illness that can compromise study participation
• Use of any medication (e.g., NSAIDs, other analgesics) < 48 hrs before the study
• Dermal diseases at the upper frontal side of the face
• Pregnancy or breastfeeding
• History of sensitivity to the fruits of capsicum plants (e.g. chilli peppers)
• Alcohol or drug abuse
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4466 |
| NTR-old | NTR5708 |
| Other | EudraCT : 2016-000279-26 |