Back to resultsThe Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
5-ISMN (isosorbide-5-mononitrate)
Sumatriptan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility 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).
Sites / Locations
- Emma Katrine Hansen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Sumatriptan
Placebo
Arm Description
headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg
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)
Outcomes
Primary Outcome Measures
Median headache score 0 hours after sumatriptan/placebo
Median headache score 2 hours after sumatriptan/placebo
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02485340
Brief Title
The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache
Official Title
The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache. Development of a Pragmatic Migraine Model
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sumatriptan
Arm Type
Active Comparator
Arm Description
headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
5-ISMN (isosorbide-5-mononitrate)
Other Intervention Name(s)
Imdur
Intervention Description
5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Intervention Type
Drug
Intervention Name(s)
Sumatriptan
Other Intervention Name(s)
Imigran
Intervention Description
5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Median headache score 0 hours after sumatriptan/placebo
Time Frame
0 hours
Title
Median headache score 2 hours after sumatriptan/placebo
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Katrine Hansen, Doctor
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emma Katrine Hansen
City
Copenhagen
State/Province
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache
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