Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT

NCT02779959 | Unknown Phase 3

• 1 other identifier: 30590-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in median sedation VAS scores

  From Time 0 (baseline) to Time 60 minutes after administration of medication

• Change in median nausea VAS scores

  From Time 0 (baseline) to Time 60 minutes after administration of medication

• Rescue Medication

  At the conclusion of the study (60 minutes)

• Follow-up for persistence or recurrence of headache

  24 -48 hours

Study Arms (2)

Buccal Prochlorperazine

EXPERIMENTAL

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

Drug: Prochlorperazine

Intravenous Prochlorperazine

ACTIVE COMPARATOR

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

Drug: Prochlorperazine

Interventions

Prochlorperazine DRUG

Buccal Prochlorperazine; Intravenous Prochlorperazine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead

Study Sites (1)

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Prochlorperazine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David Tanen, MD

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 23, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: April 1, 2018
• Last Updated: January 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)