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

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ClinicalTrials.gov Identifier: NCT02485340
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
Emma Katrine Hansen, Danish Headache Center

Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Drug: 5-ISMN (isosorbide-5-mononitrate) Drug: Sumatriptan Drug: Placebo Not Applicable

Detailed Description:

There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Isosorbide-5-mononitrate (5-ISMN), a long lasting NO-donor, induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO). To validate this model, the headache must respond to specific migraine treatment with sumatriptan.

Hypothesis: 5-ISMN 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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache. Development of a Pragmatic Migraine Model
Study Start Date : April 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Active Comparator: Sumatriptan
headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg
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
Other Name: Imdur

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
Other Name: Imigran

Placebo Comparator: Placebo
headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of placebo (the tablet is similar to the active tablet)
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
Other Name: Imdur

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




Primary Outcome Measures :
  1. Median headache score 0 hours after sumatriptan/placebo [ Time Frame: 0 hours ]
  2. Median headache score 2 hours after sumatriptan/placebo [ Time Frame: 2 hours ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy:

  • healthy subjects of both sexes
  • age 18-70 years
  • weight 50-90 kg.
  • Females were requested to use effective contraception.

Migraine patients:

  • Migraine patients who meet International headache society (IHS) criteria for migraine with or without aura of both sexes
  • 18-70 years
  • 45-95 kg.

Exclusion Criteria:

Healthy:

  • 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, and intake of daily medication (except oral contraceptives).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485340


Locations
Denmark
Emma Katrine Hansen
Copenhagen, Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Investigators
Principal Investigator: Emma Katrine Hansen, Doctor Danish Headache Center

Responsible Party: Emma Katrine Hansen, Medical doctor, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02485340     History of Changes
Other Study ID Numbers: H-6-2014-071
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Sumatriptan
Isosorbide
Isosorbide-5-mononitrate
Isosorbide Dinitrate
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Vasodilator Agents
Nitric Oxide Donors