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WithdrawnNCT01653522Updated Dec 29, 2016

The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine

An interventional study of Triptan and Doxycycline in Migraine Disorders, Headache, Migraine and Migraine, sponsored by The Cleveland Clinic. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-29.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment

Why this study was withdrawn
No participants enrolled
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Migraine Disorders
  • Headache, Migraine
  • Migraine
  • Migraine Headache
  • Migraine With Aura
  • Migraine Without Aura
  • Headache Disorders, Primary
03

In context

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

Browse Migraine Disorders studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Tetracycline group or other anti-inflammatory medication use in the preceding three months
  • Pregnant
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Triptan

    Drug: Triptan

  • Experimental
    Doxycycline

    Drug: Doxycycline

  • Experimental
    Triptan + Doxycycline

    Drug: Triptan · Drug: Doxycycline

  • No intervention
    Control

Interventions

06

What researchers measure

Primary outcomes

  1. Serum neuroinflammatory marker concentrations

Secondary outcomes

  1. Headache intensity (four-point scale)

  2. Number of participants with adverse events as a measure of safety and tolerability

  3. Time to headache relief

  4. Time to headache recurrence

07

Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2012, a primary completion of Jul 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2012
First posted
Jul 31, 2012
Start
Jul 2012
Primary completionActual
Jul 2014
CompletionActual
Jul 2014
Last update
Dec 29, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01653522
Responsible party
Sponsor
First posted
Jul 31, 2012
Start date
Jul 2012
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Dec 29, 2016

Study contacts

Shaheen E Lakhan, MD, PhD, MEd, MS
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Doxycycline

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