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van CCT (UK)

van CCT (UK)

Role of propranolol in the treatment of migraine

- candidate number24113
- NTR NumberNTR6007
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-mrt-2016
- Secondary IDs2016-000279-26 EudraCT
- Public TitleRole of propranolol in the treatment of migraine
- Scientific TitleTrigeminovascular effects of propranolol in migraine treatment
- hypothesisReduced dermal blood flow response to capsaicin application and saline iontophoresis after propranolol ocompared to placebo administration.
- Healt Condition(s) or Problem(s) studiedMigraine, Propranolol
- Inclusion criteriaAge 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 criteriaHistory 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
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-mrt-2016
- planned closingdate15-sep-2016
- Target number of participants22
- InterventionsAdministration of propranolol
- Primary outcomechange in forehead dermal blood flow
- Secondary outcomechange in heart rate
change in blood pressure
bloodlevels of propranolol
- Timepointssubject have to come twice to the Erasmus MC, with a time interval of 1 till 2 weeks
- Trial web site
- statusplanned
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summaryProphylactic 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 .
- Main changes (audit trail)
- RECORD14-mrt-2016 - 29-sep-2016

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