Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines

NCT00122278 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 05-02-032S
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 3

Brief Summary

Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.

Conditions

Migraine

Keywords

migraine, emergency department, dexamethasone; Migraine with or without aura or probable migraine without aura as defined by ICHD, 2nd edition

Outcome Measures

Primary Outcomes (1)

• Persistent Headache Pain Free at 24 Hours

  Achieve headache freedom within two hours in the emergency department and no recurrence of pain within 24 hours of emergency department discharge

  24 hours

Secondary Outcomes (1)

• Functional Disability at 24 Hours

  24 hours

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Dexamethasone 10 mg

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Placebo Dexamethasone, 10 mg

Other: Placebo

Interventions

Dexamethasone DRUG

Dexamethasone 10mg IV

Also known as: Parental corticosteroid

Dexamethasone

Placebo OTHER

Placebo Dexamethasone 10mg IV

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Migraine with or without aura; probable migraine without aura

You may not qualify if:

• Secondary headache
• Allergy, contraindication or intolerance to study medication

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (3)

Columbia University Medical Center

Manhattan, New York, United States

Location

St. Lukes Hospital

New York, New York, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Emergencies

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Benjamin W. Friedman, MD, MS
• Organization: Montefiore Medical Center

befriedm@montefiore.org

(718)920-6266

Study Officials

• Benjamin W. Friedman, MD, MS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Emergency Medicine

Study Record Dates

• First Submitted: July 20, 2005
• First Posted: July 22, 2005
• Study Start: July 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: November 13, 2018
• Results First Posted: November 13, 2018

Record last verified: 2018-04

Locations

US (3)