NCT00364806

Brief Summary

Migraine headaches are a common reason for patients to present to an emergency department. We are comparing two different medications to see which one is better for patients who present ot an emergency room with a migraine headache.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

7 months

First QC Date

August 14, 2006

Last Update Submit

April 15, 2018

Conditions

Migraine

Keywords

MigraineHeadache

Outcome Measures

Primary Outcomes (1)

  • One hour pain scores

Secondary Outcomes (1)

  • One hour, two hour and 24 hour pain, functional disability scores, and side effect profiles.

Interventions

ProchlorperazineDRUG
MetoclopramideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Present to the Ed with an acute migraine headache

You may not qualify if:

  • secondary headache
  • if the patient is to receive a lumbar puncture in the ED
  • maximum temperature greater than 100.3 degrees
  • new objective neurologic abnormality at the time of physical exam
  • allergy or intolerance to a study medication
  • pregnancy
  • previous enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Migraine DisordersHeadache

Interventions

ProchlorperazineMetoclopramide

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBenzamidesAmidespara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenols

Study Officials

  • Benjamin W Friedman, MD, MS

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Emergency Medicine

Study Record Dates

First Submitted

August 14, 2006

First Posted

August 16, 2006

Study Start

August 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

US(1)