MedTrace Logo

The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache

NCT02485340 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-01-22

No results posted yet for this study

Summary

To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with a long lasting Nitrogen Oxide (NO) donor. If the headache responds to sumatriptan, the model can be used to test new drug candidates.

Conditions

Interventions

DRUG

5-ISMN (isosorbide-5-mononitrate)

5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan

DRUG

Sumatriptan

5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan

DRUG

Placebo

5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan

Sponsors & Collaborators

  • Danish Headache Center

    lead OTHER

Principal Investigators

  • Emma Katrine Hansen, Doctor · Danish Headache Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02485340 on ClinicalTrials.gov