No registrations found.
ID
Source
Brief title
Health condition
Migraine/Migraine
Iontophoresis/Iontoforese
CGRP
Propranolol
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
change in forehead dermal blood flow
Secondary outcome
change in heart rate
change in blood pressure
bloodlevels of propranolol
Background summary
Prophylactic drugs are used by migraineurs. The most commonly recommended prophylactic drugs are the betablockers.
Among the different betablockers,
propranolol is one of the most commonly prescribed for migraine prophylaxis. It is not
known how betablockers
decrease the frequency of migraine attacks, but it is thought that it may affect the brain
serotonin receptors. Previously it has been demonstrated that the activation of serotonin receptors leds to the blockade of
CGRP liberation.
We hope to determine the role of propranolol in the prophylaxis of migraine by measuring with a laser Doppler scanner
the increase in dermal blood flow (DBF) after stimulation of the afferent nerves of the trigeminal nerve on the forehead.
The trigeminal nerve has also innervations to the dura mater, which is thought to be involved in the origin of migraine.
In order to accomplish that, the trigeminal afferent nerves will be stimulated by topical application of capsaicin and
electrical stimulation. Both stimuli lead to the release of CGRP, a vasodilator neuropeptide. We have the hypothesis, that
in migraine patients, the use of propranolol may modify the release of this neuropeptide. We will investigate this
hypothesis with the above mentioned model. First we will perform a study with healthy volunteers and in future, we hope
to perform in migraine patients with an effective prophylactic response and with an absent prophylactic response to
propranolol.
This study will provide more insight in the mechanism of action of propranolol and possibly in the pathophysiology of
migraine, which hopefully will also shed light on therapeutic targets and improved migraine treatment .
Study objective
Reduced dermal blood flow response to capsaicin application and saline iontophoresis after propranolol ocompared to placebo administration.
Study design
subject have to come twice to the Erasmus MC, with a time interval of 1 till 2 weeks
Intervention
Administration of propranolol
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 (the measurements will be held during any moment of the month, except during the week without pill) or Mirena
Non-smoking for > 6 months
Body mass index between 19 and 28 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
History of migraine
Previous history of asthma or use of bronchodilators.
Blood pressure <110 systolic (sitting)
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 | NL5765 |
| NTR-old | NTR6007 |
| Other | EudraCT : 2016-000279-26 |