NCT01653522

Brief Summary

The purpose of this study is to determine the effects of triptans and doxycycline on neuroinflammatory markers in acute migraine.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

2 years

First QC Date

July 23, 2012

Last Update Submit

December 27, 2016

Conditions

Migraine DisordersHeadache, MigraineMigraineMigraine HeadacheMigraine With AuraMigraine Without AuraHeadache Disorders, Primary

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Triptan

EXPERIMENTAL
Drug: Triptan

Doxycycline

EXPERIMENTAL
Drug: Doxycycline

Triptan + Doxycycline

EXPERIMENTAL
Drug: TriptanDrug: Doxycycline

Control

NO INTERVENTION

Interventions

TriptanDRUG
TriptanTriptan + Doxycycline
DoxycyclineDRUG
DoxycyclineTriptan + Doxycycline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Migraine DisordersMigraine with AuraMigraine without AuraHeadache Disorders, Primary

Interventions

TryptaminesDoxycycline

Condition Hierarchy (Ancestors)

Headache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Biogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Shaheen E Lakhan, MD, PhD, MEd, MS

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 31, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

December 29, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)