MigrainePhase 4NCT01138150
Ictal and Interictal Inflammatory Markers in Migraine
A Phase 4 study testing Treximet in people with Migraine, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate blood levels of several proteins that may be altered in the inflammation associated with migraine headaches. These blood levels will be evaluated in individuals during an acute migraine attack and compared to their levels when pain free. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Migraine
- What is being tested?
- Treximet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age greater than 18 years of age, migraine
Who cannot join
- Pregnant or breast-feeding women, presence of cardiovascular or cerebrovascular disorders as well as any known inflammatory, infectious, metabolic, thyroid, renal, cardiovascular or gastrointestinal diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Bayview Headache Center
Baltimore, Maryland, 21224
About this study
The purpose of this study is to evaluate blood levels of several proteins that may be altered in the inflammation associated with migraine headaches. These blood levels will be evaluated in individuals during an acute migraine attack and compared to their levels when pain free. The investigators study hypothesis is that the pro inflammatory proteins in the blood will be greater than the levels of these proteins when evaluated during a pain free period.
Read the detailed description
Migraine is a common, chronic disorder, which presents with recurrent episodes of disabling headache and affects approximately 12% of American adults.1,2 No biomarkers exist to identify episodic or chronic migraine sufferers; and the diagnosis relies solely on clinical criteria. Further the full pathophysiology of migraine has not been fully delineated, although our understanding of migraine pathophysiology has dramatically improved over the past 15 years. Current theories suggest that migraine is a neurovascular disorder, with the pain of migraine a result of the release of inflammatory neuropeptides from nerve endings in the activated trigeminal system (neurogenic inflammation), ultimately resulting in vasodilation, plasma extravasation and mast cell degranulation.3-6 Several inflammatory markers have been implicated in the pathway resulting in the neurogenic inflammation of migraine including calcitonin gene related peptide (CGRP), substance P (SP), neurokinin A, and multiple cytokines such as interleukin (IL) -1, IL-6 and tumor necrosis-α (TNF-α).5,7-10 More recent research supports that the odds of migraine are increased in those who are obese and that several adipose tissue derived cytokines (adipocytokines) may contribute to the neurogenic inflammation of migraine, including leptin and adiponectin. In one small pilot study of 33 participants evaluating chronic and episodic migraineurs as compared to controls, adiponectin (an adipocytokine) was significantly elevated in chronic migraineurs as compared to controls. A second study reported low levels of another adipocytokine, leptin in episodic migraineurs. However, all of these studies have evaluated only 3 to 4 of cytokines at the same time point and 11 none have evaluated adipocytokines during an acute attack. We hypothesize that obesity-related cytokines contribute to the neurogenic inflammation of migraine and have the potential be useful as biomarkers for episodic and chronic migraine as well as new drug targets for the treatment of migraine. To this end we propose to evaluate serum levels of obesity-related cytokines in migraineurs, ictally (during an acute migraine attack), following treatment with sumatriptan/naproxen sodium (Treximet®) and interictally (at baseline) when pain free.
- Conditions
- Migraine
- Being tested
- Treximet, Placebo
- Keywords
- migraine, headache, sumatriptan, naproxen sodium
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreximetDrug
Also called The brand name of sumatriptan/naproxen sodium is Treximet.
One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
PlaceboDrug
Also called Sugar Pill
One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
| Study group | Role | What they receive |
|---|---|---|
| Treximet | Active comparator | Fourteen participants randomized to receive Treximet (sumatriptan \& naproxen) during an acute migraine attack. Blood drawn for immune \& inflammatory markers (adipocytokines,cytokines, sex hormones) at different time points - on presentation with moderate to severe migraine pain; then 30 minutes, 1 hour and 2 hours after administration of study drug (Treximet).
Participants will be offered a traditional headache rescue medicine at 2 hours after administration of Treximet if participant still reports moderate to severe pain and desires further treatment. Rescue medicine may include the following: prochlorperazine 10 mg IV preceded by diphenhydramine 25 mg IV/PO or metoclopramide 10 mg IV preceded by diphenhydramine 25 mg IV/PO or Toradol 30 mg IV to be determined by the physician. Receives: Drug: Treximet |
| Sugar Pill | Placebo comparator | Fourteen participants randomized to receive placebo during an acute migraine attack. Blood is drawn for immune \& inflammatory markers (adipocytokines,cytokines), sex hormones at different time points - on presentation with moderate to severe migraine pain, then 30 minutes, 1 hour and 2 hours after administration of placebo.
Participants will be offered a traditional headache rescue medicine at 2 hours after administration of placebo if participant still reports moderate to severe pain and desires further treatment. Rescue medicine may include the following: prochlorperazine 10 mg IV preceded by diphenhydramine 25 mg IV/PO or metoclopramide 10 mg IV preceded by diphenhydramine 25 mg IV/PO or Toradol 30 mg IV to be determined by the physician. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Total Serum Adiponectin (T-ADP)
Change in total serum adiponectin after treatment in responders and non responders
Measured: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Secondary outcomes (7)
High Molecular Weight (HMW)-Adiponectin (ADP)
serum HMW-ADP levels after treatment in responders and non responders
Measured: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Middle Molecular Weight (MMW)-ADP
serum MMW-ADP levels after treatment in responders and non responders
Measured: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Low Molecular Weight (LMW)-ADP
serum LMW-ADP levels after treatment in responders and non responders
Measured: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
High Molecular Weight (HMW): T-ADP
serum HMW:T-ADP levels after treatment in responders and non responders
Measured: 30 minutes, 60 minutes, 120 minutes after treatment
Low Molecular Weight (LMW):Total (T)-ADP
serum LMW:T-ADP levels after treatment in responders and non responders
Measured: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Leptin
serum leptin levels after treatment in responders and non responders
Measured: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Resistin
serum resistin levels after treatment in responders and non responders
Measured: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startSep 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toledo Health Science Campus, The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Barbara L Peterlin, DO, Principal investigator, The Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138150
- Sponsor's protocol ID
- GSK112035
- Status last verified
- Aug 2016
- First submitted
- 3 Jun 2010
- Last updated
- 6 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ictal and Interictal Inflammatory Markers in Migraine
- ClinicalTrials.gov ID
- NCT01138150
- Acronym / sponsor ID
- GSK112035
- Conditions
- Migraine
- Keywords
- migraine, headache, sumatriptan, naproxen sodium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Toledo Health Science Campus, The Cleveland Clinic
- Study start
- Sep 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Posted 6 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate blood levels of several proteins that may be altered in the inflammation associated with migraine headaches. These blood levels will be evaluated in individuals during an acute migraine attack and compared to their levels when pain free. The investigators study hypothesis is that the pro inflammatory proteins in the blood will be greater than the levels of these proteins when evaluated during a pain free period.
Detailed description
Migraine is a common, chronic disorder, which presents with recurrent episodes of disabling headache and affects approximately 12% of American adults.1,2 No biomarkers exist to identify episodic or chronic migraine sufferers; and the diagnosis relies solely on clinical criteria. Further the full pathophysiology of migraine has not been fully delineated, although our understanding of migraine pathophysiology has dramatically improved over the past 15 years. Current theories suggest that migraine is a neurovascular disorder, with the pain of migraine a result of the release of inflammatory neuropeptides from nerve endings in the activated trigeminal system (neurogenic inflammation), ultimately resulting in vasodilation, plasma extravasation and mast cell degranulation.3-6 Several inflammatory markers have been implicated in the pathway resulting in the neurogenic inflammation of migraine including calcitonin gene related peptide (CGRP), substance P (SP), neurokinin A, and multiple cytokines such as interleukin (IL) -1, IL-6 and tumor necrosis-α (TNF-α).5,7-10 More recent research supports that the odds of migraine are increased in those who are obese and that several adipose tissue derived cytokines (adipocytokines) may contribute to the neurogenic inflammation of migraine, including leptin and adiponectin. In one small pilot study of 33 participants evaluating chronic and episodic migraineurs as compared to controls, adiponectin (an adipocytokine) was significantly elevated in chronic migraineurs as compared to controls. A second study reported low levels of another adipocytokine, leptin in episodic migraineurs. However, all of these studies have evaluated only 3 to 4 of cytokines at the same time point and 11 none have evaluated adipocytokines during an acute attack. We hypothesize that obesity-related cytokines contribute to the neurogenic inflammation of migraine and have the potential be useful as biomarkers for episodic and chronic migraine as well as new drug targets for the treatment of migraine. To this end we propose to evaluate serum levels of obesity-related cytokines in migraineurs, ictally (during an acute migraine attack), following treatment with sumatriptan/naproxen sodium (Treximet®) and interictally (at baseline) when pain free.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treximet | Active comparator | Drug: TreximetFourteen participants randomized to receive Treximet (sumatriptan \& naproxen) during an acute migraine attack. Blood drawn for immune \& inflammatory markers (adipocytokines,cytokines, sex hormones) at different time points - on presentation with moderate to severe migraine pain; then 30 minutes, 1 hour and 2 hours after administration of study drug (Treximet). Participants will be offered a traditional headache rescue medicine at 2 hours after administration of Treximet if participant still reports moderate to severe pain and desires further treatment. Rescue medicine may include the following: prochlorperazine 10 mg IV preceded by diphenhydramine 25 mg IV/PO or metoclopramide 10 mg IV preceded by diphenhydramine 25 mg IV/PO or Toradol 30 mg IV to be determined by the physician. |
| Sugar Pill | Placebo comparator | Drug: PlaceboFourteen participants randomized to receive placebo during an acute migraine attack. Blood is drawn for immune \& inflammatory markers (adipocytokines,cytokines), sex hormones at different time points - on presentation with moderate to severe migraine pain, then 30 minutes, 1 hour and 2 hours after administration of placebo. Participants will be offered a traditional headache rescue medicine at 2 hours after administration of placebo if participant still reports moderate to severe pain and desires further treatment. Rescue medicine may include the following: prochlorperazine 10 mg IV preceded by diphenhydramine 25 mg IV/PO or metoclopramide 10 mg IV preceded by diphenhydramine 25 mg IV/PO or Toradol 30 mg IV to be determined by the physician. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age greater than 18 years of age, migraine
Key exclusion criteria (1 listed)
- Pregnant or breast-feeding women, presence of cardiovascular or cerebrovascular disorders as well as any known inflammatory, infectious, metabolic, thyroid, renal, cardiovascular or gastrointestinal diseases
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 |
|---|---|---|
| TreximetAlso: The brand name of sumatriptan/naproxen sodium is Treximet.One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn. | Drug | Treximet |
| PlaceboAlso: Sugar PillOne tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn. | Drug | Sugar Pill |
Primary outcome
Change in the Total Serum Adiponectin (T-ADP)
Time frame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Change in total serum adiponectin after treatment in responders and non responders
7 secondary outcomes
High Molecular Weight (HMW)-Adiponectin (ADP)
Time frame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Middle Molecular Weight (MMW)-ADP
Time frame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Low Molecular Weight (LMW)-ADP
Time frame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
High Molecular Weight (HMW): T-ADP
Time frame: 30 minutes, 60 minutes, 120 minutes after treatment
Low Molecular Weight (LMW):Total (T)-ADP
Time frame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Leptin
Time frame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Resistin
Time frame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Barbara L Peterlin, DO principal investigator
The Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Treximet in people with Migraine, run by Johns Hopkins University at 1 site in United States.
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 1 inclusion and 1 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 6 Oct 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in the Total Serum Adiponectin (T-ADP) (time frame: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment). 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 6 Oct 2016.