Migraine DisordersNCT01653522
The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine
A study testing Triptan and Doxycycline in people with Migraine Disorders and Headache, Migraine, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of triptans and doxycycline on neuroinflammatory markers in acute migraine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders, Headache, Migraine, Migraine
- What is being tested?
- Triptan and Doxycycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of migraine with or without aura that fulfill the 2nd Edition of The International Headache Classification (ICHD-II) criteria
- Active prescription for an oral triptan medication to abort acute migraines
Who cannot join
- Tetracycline group or other anti-inflammatory medication use in the preceding three months
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effects of triptans and doxycycline on neuroinflammatory markers in acute migraine.
Read the detailed description
Increased inflammatory cytokines and matrix metalloproteinases (MMPs) have been recently implicated in migraine. Inflammation may be a key player in the pathophysiology of migraine by altering blood-brain barrier (BBB) function. As an inflammation induced MMP, MMP-9 is involved in both BBB disruption and neuropathic pain, and is largely derived by neutrophil degranulation during neutrophil-BBB interaction. The tetracycline group of antibiotics may suppress MMP production and neutrophil degranulation. This study aims to investigate known neuroinflammatory biomarkers with a focus on BBB breakdown during acute migraine attacks and assess marker responses to conventional treatment (triptans) and novel MMP targeted therapy (doxycycline). This pilot project data will supplement future projects investigating novel therapeutic strategies such as MMP inhibitors in both migraine acute treatment and prevention.
- Conditions
- Migraine Disorders, Headache, Migraine, Migraine, Migraine Headache, Migraine With Aura, Migraine Without Aura
- Being tested
- Triptan, Doxycycline
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura, Headache Disorders, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriptanDrug
DoxycyclineDrug
| Study group | Role | What they receive |
|---|---|---|
| Triptan | Experimental | Not described Receives: Drug: Triptan |
| Doxycycline | Experimental | Not described Receives: Drug: Doxycycline |
| Triptan + Doxycycline | Experimental | Not described Receives: Drug: Triptan; Drug: Doxycycline |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum neuroinflammatory marker concentrations
Secondary outcomes (4)
Headache intensity (four-point scale)
Number of participants with adverse events as a measure of safety and tolerability
Time to headache relief
Time to headache recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaheen E Lakhan, MD, PhD, MEd, MS, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653522
- Sponsor's protocol ID
- 12-061
- Status last verified
- Dec 2016
- First submitted
- 23 Jul 2012
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine
- ClinicalTrials.gov ID
- NCT01653522
- Acronym / sponsor ID
- 12-061
- Conditions
- Migraine Disorders, Headache, Migraine, Migraine, Migraine Headache, Migraine With Aura, Migraine Without Aura
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 31 Jul 2012 (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.
The purpose of this study is to determine the effects of triptans and doxycycline on neuroinflammatory markers in acute migraine.
Detailed description
Increased inflammatory cytokines and matrix metalloproteinases (MMPs) have been recently implicated in migraine. Inflammation may be a key player in the pathophysiology of migraine by altering blood-brain barrier (BBB) function. As an inflammation induced MMP, MMP-9 is involved in both BBB disruption and neuropathic pain, and is largely derived by neutrophil degranulation during neutrophil-BBB interaction. The tetracycline group of antibiotics may suppress MMP production and neutrophil degranulation. This study aims to investigate known neuroinflammatory biomarkers with a focus on BBB breakdown during acute migraine attacks and assess marker responses to conventional treatment (triptans) and novel MMP targeted therapy (doxycycline). This pilot project data will supplement future projects investigating novel therapeutic strategies such as MMP inhibitors in both migraine acute treatment and prevention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Triptan | Experimental | Drug: Triptan |
| Doxycycline | Experimental | Drug: Doxycycline |
| Triptan + Doxycycline | Experimental | Drug: Triptan, Drug: Doxycycline |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of migraine with or without aura that fulfill the 2nd Edition of The International Headache Classification (ICHD-II) criteria
- Active prescription for an oral triptan medication to abort acute migraines
Key exclusion criteria (2 listed)
- Tetracycline group or other anti-inflammatory medication use in the preceding three months
- Pregnant
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 |
|---|---|---|
| Triptan | Drug | Triptan, Triptan + Doxycycline |
| Doxycycline | Drug | Doxycycline, Triptan + Doxycycline |
Primary outcome
Serum neuroinflammatory marker concentrations
4 secondary outcomes
Headache intensity (four-point scale)
Number of participants with adverse events as a measure of safety and tolerability
Time to headache relief
Time to headache recurrence
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- 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.
Shaheen E Lakhan, MD, PhD, MEd, MS principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triptan and Doxycycline in people with Migraine Disorders and Headache, Migraine, run by The Cleveland Clinic 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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 29 Dec 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Serum neuroinflammatory marker concentrations. 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 29 Dec 2016.