Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT

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.

Study Overview

• Status: Unknown
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: Prochlorperazine

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90502
      • Harbor-UCLA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Time 0 (baseline) to Time 60 minutes after administration of medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Time 0 (baseline) to Time 60 minutes after administration of medication
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.	From Time 0 (baseline) to Time 60 minutes after administration of medication
Rescue Medication	Comparison between groups for the need for rescue medication as determined by the primary care provider.	At the conclusion of the study (60 minutes)
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.	24 -48 hours

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (Estimate): May 23, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: January 3, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; Prochlorperazine
• Other Study ID Numbers: 30590-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No