To determine the mechanism of action of propranolol in the prophylactic treatment of migraine.
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in dermal blood flow response to capsaicin application and saline
iontophoresis, after propranolol intake.
Secondary outcome
Changes in blood pressure after propranolol use.
Background summary
Prophylactic drugs are used by migraineurs. The most commonly recommended
prophylactic drugs are the beta-blockers. Among the different beta-blockers,
propranolol is one of the most commonly prescribed for migraine prophylaxis. It
is not known how beta-blockers 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
To determine the mechanism of action of propranolol in the prophylactic
treatment of migraine.
Study design
A randomized double blind controlled cross over study
Intervention
Oral administration of propranolol 80mg (oral solution)
Study burden and risks
The amount of time consumed by this research and the side effects of
propranolol are the burden. Capsaicin application can cause temporary redness
and some irritation of the skin.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Age between 18 and 64 years
Non-smoking for more than 6 months
Females should use an oral contraceptive pill
Body mass index between 19 and 28 kg/m^2
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, as well as during 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
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2016-000279-26-NL |
| CCMO | NL56536.078.16 |