Prochlorperazine vs Imitrex for Acute Migraine in the Eme... | NCT00573599

Studies
Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department

NCT00573599

Sponsor

United States Naval Medical Center, Portsmouth

Status

Withdrawn

Last Update Posted

Aug 19, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Acute Migraine Headache

Interventions

prochlorperazine and benadryl IV
Imitrex SubQ, saline IV

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

unable to recruit participants

Expanded Access Info

Start Date

Feb 2007Actual

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Dec 13, 2007

First Submission Date that Met QC Criteria

Dec 13, 2007

First Posted Date

Dec 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2025

Last Update Posted Date

Aug 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
prochlorperazine and benadryl IV	Drug	prochlorperazine and benadryl IV, saline subQ	1

Measure	Description	Time Frame
Difference in pain measured by VAS		80 min

Measure	Description	Time Frame
Degree of sedation, nausea, akathisia		80 min

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute migraine headache

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank Gutierrez, MD	US Navy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Naval Medical Center Portsmouth		Portsmouth	Virginia	23708	United States

Condition Browse Module

MeSH Terms

ID	Term
D008881	Migraine Disorders
D004630	Emergencies

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011346	Prochlorperazine

Ancestor Terms

ID	Term
D010640	Phenothiazines
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006575	Heterocyclic Compounds, 3-Ring

Browse Leaves

Not provided

Browse Branches

Not provided