Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT

Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02779959

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine Disorders	Drug: Prochlorperazine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT

Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Oct 1, 2017

Anticipated Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Buccal Prochlorperazine Experimental arm of two buccally absorbable prochlorperazine tablets (6 mg) plus 2 cc IV saline	Drug: Prochlorperazine
Active Comparator: Intravenous Prochlorperazine Accepted Standard of care receiving 10 mg (2 cc) of intravenous prochlorperazine plus two saccharin absorbable placebo tablets.	Drug: Prochlorperazine

Arm

Intervention/Treatment

Experimental: Buccal Prochlorperazine

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

Drug: Prochlorperazine

Active Comparator: Intravenous Prochlorperazine

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

Drug: Prochlorperazine

Outcome Measures

Primary Outcome Measures

Change in median pian VAS score [From Time 0 (baseline) to Time 60 minutes after administration of medication]
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 [From Time 0 (baseline) to Time 60 minutes after administration of medication]
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 [From Time 0 (baseline) to Time 60 minutes after administration of medication]
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 [At the conclusion of the study (60 minutes)]
Comparison between groups for the need for rescue medication as determined by the primary care provider.
Follow-up for persistence or recurrence of headache [24 -48 hours]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harbor-UCLA Medical Center	Torrance	California	United States	90502

Sponsors and Collaborators

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Investigators

Principal Investigator: David Tanen, MD, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Tanen, Professor of Medicine, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

ClinicalTrials.gov Identifier:

NCT02779959

Other Study ID Numbers:

30590-01

First Posted:

May 23, 2016

Last Update Posted:

Jan 5, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Migraine Disorders

Headache

Prochlorperazine

Study Results

No Results Posted as of Jan 5, 2018