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Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT

This study is currently recruiting participants.
Verified June 2017 by David Tanen, Los Angeles Biomedical Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02779959
First Posted: May 23, 2016
Last Update Posted: June 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
David Tanen, Los Angeles Biomedical Research Institute
  Purpose
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 Intervention Phase
Migraine Disorders Drug: Prochlorperazine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by David Tanen, Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • Change in median pian VAS score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Estimated Enrollment: 80
Study Start Date: April 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779959


Contacts
Contact: David Tanen, MD 310-222-3501 dtanen@emedharbor.edu

Locations
United States, California
Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: David Tanen, MD    210-222-3501    dtanen@emedharbor.edu   
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Investigators
Principal Investigator: David Tanen, MD Los Angeles Biomedical Research Institute
  More Information

Responsible Party: David Tanen, Professor of Medicine, Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT02779959     History of Changes
Other Study ID Numbers: 30590-01
First Submitted: May 17, 2016
First Posted: May 23, 2016
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Prochlorperazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action