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Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT

Primary Purpose

Migraine Disorders

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Prochlorperazine
Sponsored by
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients between 18-65 years of age evaluated in the emergency department at Harbor-UCLA with migraine headache as defined by the Headache Classification Committee of the International Headache Society. (Patients must have had at least one prior similar headache, with or without nausea, vomiting, aura, photophobia, or phonophobia).
  • Only subjects able to consent to treatment will be included.

Exclusion Criteria:

Patients with the following conditions:

  • pregnancy
  • breastfeeding
  • fever greater or equal to 100.4 degrees
  • diastolic blood pressure of 105 or higher
  • altered mental status
  • meningeal signs
  • suspicion for intracranial process requiring further investigation
  • known allergy to prochlorperazine
  • the use of ergotamines, antiemetics, antipsychotics or sedatives in the previous 24 hours of study entry.

Sites / Locations

  • Harbor-UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Buccal Prochlorperazine

Intravenous Prochlorperazine

Arm Description

Experimental arm of two buccally absorbable prochlorperazine tablets (6 mg) plus 2 cc IV saline

Accepted Standard of care receiving 10 mg (2 cc) of intravenous prochlorperazine plus two saccharin absorbable placebo tablets.

Outcomes

Primary Outcome Measures

Change in median pian VAS score
Primary end point will be a detectable difference in the median pain VAS score recorded from Time 0 (baseline) to Time 60 minutes (conclusion of the study) for each of the two groups.

Secondary Outcome Measures

Change in median sedation VAS scores
Secondary endpoints will include a detectable difference in median sedation VAS scale from Time 0 (baseline) to Time 60 minutes (conclusion of the study for each of the two groups.
Change in median nausea VAS scores
Secondary endpoints will include a detectable difference in median nausea VAS scale from Time 0 (baseline) to Time 60 minutes (conclusion of the study for each of the two groups.
Rescue Medication
Comparison between groups for the need for rescue medication as determined by the primary care provider.
Follow-up for persistence or recurrence of headache
Using a Pain Relief Scale, subjects will be contacted by telephone at 24 - 48 hours after the conclusion of the study and asked to rate their current headache pain.

Full Information

First Posted
May 17, 2016
Last Updated
January 3, 2018
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02779959
Brief Title
Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT
Official Title
Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Headache is a common presenting complaint to the emergency department accounting for 1-2% of patient visits. Of these headaches, approximately 90% are migraine, tension headache, or combined presentations. The most commonly used migraine therapy in the ED is intravenous prochlorperazine, but its administration requires close nursing observation, a bed, and the insertion of an intravenous catheter. Buccal prochlorperazine represents an alternative form of delivery that enables rapid achievement of therapeutic blood levels and may lead to symptom resolution. In a randomized, controlled, prospective study,the investigators plan to assess the efficacy of buccal versus intravenous prochlorperazine for the initial emergency department treatment of migraine headaches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buccal Prochlorperazine
Arm Type
Experimental
Arm Description
Experimental arm of two buccally absorbable prochlorperazine tablets (6 mg) plus 2 cc IV saline
Arm Title
Intravenous Prochlorperazine
Arm Type
Active Comparator
Arm Description
Accepted Standard of care receiving 10 mg (2 cc) of intravenous prochlorperazine plus two saccharin absorbable placebo tablets.
Intervention Type
Drug
Intervention Name(s)
Prochlorperazine
Primary Outcome Measure Information:
Title
Change in median pian VAS score
Description
Primary end point will be a detectable difference in the median pain VAS score recorded from Time 0 (baseline) to Time 60 minutes (conclusion of the study) for each of the two groups.
Time Frame
From Time 0 (baseline) to Time 60 minutes after administration of medication
Secondary Outcome Measure Information:
Title
Change in median sedation VAS scores
Description
Secondary endpoints will include a detectable difference in median sedation VAS scale from Time 0 (baseline) to Time 60 minutes (conclusion of the study for each of the two groups.
Time Frame
From Time 0 (baseline) to Time 60 minutes after administration of medication
Title
Change in median nausea VAS scores
Description
Secondary endpoints will include a detectable difference in median nausea VAS scale from Time 0 (baseline) to Time 60 minutes (conclusion of the study for each of the two groups.
Time Frame
From Time 0 (baseline) to Time 60 minutes after administration of medication
Title
Rescue Medication
Description
Comparison between groups for the need for rescue medication as determined by the primary care provider.
Time Frame
At the conclusion of the study (60 minutes)
Title
Follow-up for persistence or recurrence of headache
Description
Using a Pain Relief Scale, subjects will be contacted by telephone at 24 - 48 hours after the conclusion of the study and asked to rate their current headache pain.
Time Frame
24 -48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between 18-65 years of age evaluated in the emergency department at Harbor-UCLA with migraine headache as defined by the Headache Classification Committee of the International Headache Society. (Patients must have had at least one prior similar headache, with or without nausea, vomiting, aura, photophobia, or phonophobia). Only subjects able to consent to treatment will be included. Exclusion Criteria: Patients with the following conditions: pregnancy breastfeeding fever greater or equal to 100.4 degrees diastolic blood pressure of 105 or higher altered mental status meningeal signs suspicion for intracranial process requiring further investigation known allergy to prochlorperazine the use of ergotamines, antiemetics, antipsychotics or sedatives in the previous 24 hours of study entry.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Tanen, MD
Organizational Affiliation
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT

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