Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department

NCT00573599 | Withdrawn DMC

• 1 other identifier: P06-050
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is improvement in pain scales between the groups.

Conditions

Acute Migraine Headache

Keywords

Migraine; Emergency; imitrex; prochlorperazine; Acute Migraine Headache in the Emergency Department

Outcome Measures

Primary Outcomes (1)

• Difference in pain measured by VAS

  80 min

Secondary Outcomes (1)

• Degree of sedation, nausea, akathisia

  80 min

Study Arms (2)

1

EXPERIMENTAL

prochlorperazine and benadryl IV, saline subQ

Drug: prochlorperazine and benadryl IV

2

ACTIVE COMPARATOR

imitrex SubQ, saline IV

Drug: Imitrex SubQ, saline IV

Interventions

prochlorperazine and benadryl IV DRUG

prochlorperazine and benadryl IV, saline subQ

1

Imitrex SubQ, saline IV DRUG

Imitrex SubQ, saline IV

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Acute migraine headache

You may not qualify if:

• Pregnant
• Hypertension
• Chest pain
• \< 18
• Allergy to any of the meds

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth: lead

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Emergencies

Interventions

Prochlorperazine

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)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Frank Gutierrez, MD

  US Navy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 14, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

US (1)