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Phenothiazine Antipsychotic

Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT

Phase 3
Waitlist Available
Led By David Tanen, MD
Research Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 -48 hours
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group

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.

Eligible Conditions
  • Migraine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 -48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 -48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in median pian VAS score
Secondary study objectives
Change in median nausea VAS scores
Change in median sedation VAS scores
Headache
+1 more

Side effects data

From 2016 Phase 4 trial • 127 Patients • NCT02389829
14%
Dizzy
6%
Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hydromorphone
Prochlorperazine

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Buccal ProchlorperazineExperimental Treatment1 Intervention
Experimental arm of two buccally absorbable prochlorperazine tablets (6 mg) plus 2 cc IV saline
Group II: Intravenous ProchlorperazineActive Control1 Intervention
Accepted Standard of care receiving 10 mg (2 cc) of intravenous prochlorperazine plus two saccharin absorbable placebo tablets.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prochlorperazine
FDA approved

Find a Location

Who is running the clinical trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLead Sponsor
104 Previous Clinical Trials
46,503 Total Patients Enrolled
David Tanen, MDPrincipal InvestigatorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
2 Previous Clinical Trials
224 Total Patients Enrolled
~8 spots leftby Dec 2025
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