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Role of propranolol on migraine treatment


- candidate number23694
- NTR NumberNTR5708
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-feb-2016
- Secondary IDs2016-000279-26 EudraCT
- Public TitleRole of propranolol on migraine treatment
- Scientific TitleTrigeminovascular effects of propranolol in migraine treatment
- ACRONYMTREPMI
- hypothesisThe administration of propranolol will inhibit the increase in dermal blood flow (DBF) induced by capsaicin application.
- Healt Condition(s) or Problem(s) studiedMigraine, Propranolol
- 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
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2016
- planned closingdate1-sep-2016
- Target number of participants22
- InterventionsThe volunteers will need to take a tablet of Propranolol 80mg (which is the normal therapeutic dose)
- Primary outcomeChanges in dermal blood flow response to capsaicin application and saline iontophoresis, after propranolol administration.
- Secondary outcomeBlood pressure changes after propranolol use.
- TimepointsThe volunteers will come twice to Erasmus MC. Each appointment will last an estimated of 150 minutes.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. J. Langendonk
- CONTACT for SCIENTIFIC QUERIESDr. J. Langendonk
- Sponsor/Initiator Dr. A.H. van den Meiracker, Erasmus Medical Center Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- Publications
- Brief summaryMigraine 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.
- Main changes (audit trail)
- RECORD1-feb-2016 - 25-apr-2016


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