The Effect of Sumatriptan and Placebo on CGRP Induced Headache
NCT ID: NCT03542357
Last Updated: 2019-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-02-15
2018-09-01
Brief Summary
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Detailed Description
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Hypothesis: CGRP induces a migraine-like headache in both healthy subjects and in MO-patients and induced headache responds to a specific anti migraine drug; sumatriptan.
Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Sumatriptan
headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg as a pre-treatment
Calcitonin Gene Related Peptide
CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Sumatriptan 50 mg
CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Placebo
headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of placebo as a pre-treatment
Calcitonin Gene Related Peptide
CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Placebo Oral Tablet
CGRPis given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Interventions
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Calcitonin Gene Related Peptide
CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Sumatriptan 50 mg
CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Placebo Oral Tablet
CGRPis given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Healthy subjects of both sexes Age 18-60 years Weight 45-95 kg. Females were requested to use effective contraception.
Migraine patients:
Migraine patients who meet IHS criteria for migraine with or without aura of both sexes 18-60 years 45-95 kg.
Exclusion Criteria
Any type of headache (except episodic tension-type headache \< 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives).
Migraine patients:
Any other type of headache then migraine without aura (except episodic tension-type headache \< 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives) Triptan non-responders
18 Years
60 Years
ALL
Yes
Sponsors
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Danish Headache Center
OTHER
Responsible Party
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Katrine Falkenberg
Medical doctor
Locations
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Rigshospitalet Glostrup
Glostrup Municipality, , Denmark
Countries
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Other Identifiers
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H-16000065
Identifier Type: -
Identifier Source: org_study_id
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