Ictal and Interictal Inflammatory Markers in Migraine

NCT01138150 | Completed Phase 4 Results

• 1 other identifier: GSK112035
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Migraine

Keywords

migraine, headache, sumatriptan, naproxen sodium

Outcome Measures

Primary Outcomes (1)

• Change in the Total Serum Adiponectin (T-ADP)

  Change in total serum adiponectin after treatment in responders and non responders

  30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment

Secondary Outcomes (7)

• High Molecular Weight (HMW)-Adiponectin (ADP)

  30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment

• Middle Molecular Weight (MMW)-ADP

  30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment

• Low Molecular Weight (LMW)-ADP

  30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment

• High Molecular Weight (HMW): T-ADP

  30 minutes, 60 minutes, 120 minutes after treatment

• Low Molecular Weight (LMW):Total (T)-ADP

  30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Treximet DRUG

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.

Also known as: The brand name of sumatriptan/naproxen sodium is Treximet.

Treximet

Placebo DRUG

One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.

Also known as: Sugar Pill

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age greater than 18 years of age, migraine

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Toledo Health Science Campus: collaborator
• The Cleveland Clinic: collaborator

Study Sites (1)

The Johns Hopkins Bayview Headache Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

sumatriptan-naproxen; Sugars

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Dr. Lee Peterlin
• Organization: The Johns Hopkins University School of Medicine

lpeterlin@jhmi.edu

410-550-5452

Study Officials

• Barbara L Peterlin, DO

  The Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 7, 2010
• Study Start: September 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 6, 2016
• Results First Posted: October 6, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)