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Sumatriptan non-responders: research of a possible identifying test

Sumatriptan non-responders: evaluation of a possible biomarker - SNEB

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-005256-34-NL
Enrollment
Unknown
Registered
2012-09-13
Start date
2012-10-29
Completion date
Unknown
Last updated
2012-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers (Migraine) MedDRA version: 15.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Imigran 6 s.c. oplossing voor injectie voor subcutaan gebruik Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: SUMATRIPTAN SUCCINATE CAS Number: 80000

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 21 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
Main Objective: Investigate the effect of sumatriptan and placebo on the rise of dermal blood flow caused by capsaicin application and iontophoresis of normal saline. ;Secondary Objective: To develop a biomarker in order to identify sumatriptan non-responders.;Primary end point(s): Changes in dermal blood flow response to capsaicin application en saline iontophoresis, after sumatriptan or placebo administration.;Timepoint(s) of evaluation of this end point: At 6 months—

Secondary

MeasureTime frame
Secondary end point(s): Heat sensation after capsaicin appliacation Blood pressure changes after sumatriptan use;Timepoint(s) of evaluation of this end point: At 6 months—

Countries

Netherlands

Contacts

Public ContactA.H. van den Meiracker

Erasmus MC

a.vandenmeiracker@erasmusmc.nl00310107034220

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026