Ictal and Interictal Inflammatory Markers in Migraine
This study is currently recruiting participants.
Verified August 2011 by Johns Hopkins University
Sponsor:
Johns Hopkins University
Collaborators:
University of Toledo Health Science Campus
The Cleveland Clinic
Information provided by (Responsible Party):
Drs Barbara Peterlin, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01138150
First received: June 3, 2010
Last updated: April 1, 2013
Last verified: August 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine |
Drug: sumatriptan/naproxen sodium Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) |
| Official Title: | Ictal and Interictal Inflammatory Markers in Migraine |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- Blood levels of proteins will be evaluated at baseline when subjects are pain-free and then repeated during an acute attack, both prior to drug administration and then at 30 minutes, 1 hour and 2 hours after acute treatment. [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Treximet |
Drug: sumatriptan/naproxen sodium
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.
Other Name: The brand name of sumatriptan/naproxen sodium is Treximet.
|
| Placebo Comparator: Sugar Pill |
Drug: Placebo
One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age greater than 18 years of age, migraine
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138150
Contacts
| Contact: Barbara L Peterlin, DO | 410-550-9550 | lpeterlin@jhmi.edu |
| Contact: LInda W White, MS, CRNP | 410-550-4418 | lwhite@jhmi.edu |
Locations
| United States, Maryland | |
| The Johns Hopkins Bayview Headache Center | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Barbara L Peterlin, D.O. 215-410-2794 lpeterlin@jhmi.edu | |
| Contact: Linda White, MS,CRNP 410-550-4418 lwhite@jhmi.edu | |
| Principal Investigator: Barbara L Peterlin, DO | |
Sponsors and Collaborators
Johns Hopkins University
University of Toledo Health Science Campus
The Cleveland Clinic
Investigators
| Principal Investigator: | Barbara L Peterlin, DO | The Johns Hopkins University |
More Information
No publications provided
| Responsible Party: | Drs Barbara Peterlin, Director, The Johns Hopkins Bayview Headache Research, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01138150 History of Changes |
| Obsolete Identifiers: | NCT00868322 |
| Other Study ID Numbers: | GSK112035 |
| Study First Received: | June 3, 2010 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
migraine, headache, sumatriptan, naproxen sodium |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Naproxen Sumatriptan Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Vasoconstrictor Agents Cardiovascular Agents Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on June 18, 2013