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Sumatriptan non-responders: evaluation of a possible biomarker.


- candidate number15397
- NTR NumberNTR4171
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-sep-2013
- Secondary IDs Erasmus MC MEC-2012-326 
- Public TitleSumatriptan non-responders: evaluation of a possible biomarker.
- Scientific TitleSumatriptan non-responders: evaluation of a possible biomarker.
- ACRONYMSNEB
- hypothesisSumatriptan can block the increase in dermal blood flow (DBF) caused by application of capsaicin or electrical stimulation.
- Healt Condition(s) or Problem(s) studiedMigraine
- Inclusion criteria Age between 18 and 50 years
Male or female
Females should use an oral contraceptive pill
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
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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-sep-2013
- planned closingdate
- Target number of participants21
- InterventionsS.C. injection of sumatriptan
- Primary outcomePercentage of change in dermal blood flow response to capsaicin application and saline iontophoresis after sumatriptan or placebo administration.
- Secondary outcome Heat sensation after capsaicin application
Blood pressure changes after sumatriptan use
- TimepointsStart recruitment: 10-09-2013
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD A.H. Meiracker, van den
- CONTACT for SCIENTIFIC QUERIESMD, PhD A.H. Meiracker, van den
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Hersenstichting Nederland
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD10-sep-2013 - 29-sep-2013


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