MigraineNCT02485340
The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache
A study testing 5-ISMN (isosorbide-5-mononitrate) and Sumatriptan in people with Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- 5-ISMN (isosorbide-5-mononitrate) and Sumatriptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy:
- healthy subjects of both sexes
- age 18-70 years
- weight 50-90 kg.
- Females were requested to use effective contraception.
- Migraine patients:
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- Migraine patients who meet International headache society (IHS) criteria for migraine with or without aura of both sexes
- 18-70 years
- 45-95 kg.
Who cannot join
- 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:
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache. Development of a Pragmatic Migraine Model
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.
Read the 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
- Conditions
- Migraine
- Being tested
- 5-ISMN (isosorbide-5-mononitrate), Sumatriptan, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-ISMN (isosorbide-5-mononitrate)Drug
Also called Imdur
5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
SumatriptanDrug
Also called Imigran
5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
PlaceboDrug
5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
| Study group | Role | What they receive |
|---|---|---|
| Sumatriptan | Active comparator | headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg Receives: Drug: 5-ISMN (isosorbide-5-mononitrate); Drug: Sumatriptan |
| Placebo | Placebo comparator | 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) Receives: Drug: 5-ISMN (isosorbide-5-mononitrate); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median headache score 0 hours after sumatriptan/placebo
Measured: 0 hours
Median headache score 2 hours after sumatriptan/placebo
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emma Katrine Hansen, Danish Headache Center
- Investigators
- Emma Katrine Hansen, Doctor, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485340
- Sponsor's protocol ID
- H-6-2014-071
- Status last verified
- Jan 2016
- First submitted
- 4 Jun 2015
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache. Development of a Pragmatic Migraine Model
- ClinicalTrials.gov ID
- NCT02485340
- Acronym / sponsor ID
- H-6-2014-071
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sumatriptan | Active comparator | Drug: 5-ISMN (isosorbide-5-mononitrate), Drug: Sumatriptanheadache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg |
| Placebo | Placebo comparator | Drug: 5-ISMN (isosorbide-5-mononitrate), Drug: Placeboheadache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of placebo (the tablet is similar to the active tablet) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- healthy subjects of both sexes
- age 18-70 years
- weight 50-90 kg.
- Females were requested to use effective contraception.
- Migraine patients who meet International headache society (IHS) criteria for migraine with or without aura of both sexes
Key exclusion criteria (9 listed)
- 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).
- Any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-ISMN (isosorbide-5-mononitrate)Also: Imdur5-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, Sumatriptan |
| SumatriptanAlso: Imigran5-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 |
| Placebo5-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 |
Primary outcome
Median headache score 0 hours after sumatriptan/placebo
Time frame: 0 hours
Median headache score 2 hours after sumatriptan/placebo
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Katrine Hansen, Doctor principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-ISMN (isosorbide-5-mononitrate) and Sumatriptan in people with Migraine, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median headache score 0 hours after sumatriptan/placebo (time frame: 0 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2016.