To find a simple test to explain non-responsiveness to sumatriptan in a proportion of patients with 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 en saline
iontophoresis, after sumatriptan administration.
Secondary outcome
Blood pressure changes after sumatriptan use.
Background summary
The introduction of triptans approximately 20 years ago was a great improvement
in the treatment of migraine. Unfortunately with triptans not all migraine
patients can be treated successfully. The cause of this treatment failure is
not clear yet. We hope to determine the cause 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
also innervates the dura mater, where the migraine is thought to have its
origin. The trigeminal afferent nerves will be stimulated by topical
application of capsaicin and electrical stimulation via iontophoresis of
saline. Both stimuli lead to release of the vasodilator neuropeptide CGRP. In a
pilot study we have shown that these stimuli indeed increase DBF. We think that
in migraine patients with a good clinical response to sumatriptan the release
of CGRP is inhibited, but in patients with a poor or absent clinical response
to sumatriptan the CGRP release is not blocked. We will investigate this
hypothesis with the above mentioned model. First we will perform a study with
healthy volunteers and in future this study will be performed in migraine
patients with a consistently good or absent response to sumatriptan. This study
will provide more insight in the action of sumatriptan resulting in more
personalised treatment of patient with migraine.
Study objective
To find a simple test to explain non-responsiveness to sumatriptan in a
proportion of patients with migraine.
Study design
A randomised double blind controlled crossover study
Intervention
Sumatriptan succinate 6 mg/ 0,5 ml (which is the normal therapeutic dose)
subcutaneously.
Study burden and risks
The amount of time consumed by this research and the side effects of
sumatriptan 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 50 years
Non-smoking for > 6 months
Body mass index between 18 and 30 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
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
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 | EUCTR2011-005256-34-NL |
| CCMO | NL38589.078.12 |