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SPG Block for Headache

Phase 4
Waitlist Available
Led By Tony Zitek, MD
Research Sponsored by Kendall Healthcare Group, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Any patient at least 18 years old who presented to the ED with a suspected primary headache.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-72 hours
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial will compare a nerve block to standard headache medication for people who come to the ER for a headache.

Eligible Conditions
  • Headache

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-72 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
Percentage of Patients with Substantial Pain Reduction at 15 minutes
Secondary study objectives
Change in Mean Pain Score at 15 minutes
Change in Mean Pain Score at 30 minutes
Headache 24-72 hours later
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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: SPG BlockExperimental Treatment1 Intervention
Sphenopalatine ganglion block using cotton-tipped applicators soaked in 1% lidocaine will be performed.
Group II: Standard TreatmentActive Control1 Intervention
Intravenous prochlorperazine 10 mg plus diphenhydramine 50 mg.

Find a Location

Who is running the clinical trial?

Kendall Healthcare Group, Ltd.Lead Sponsor
6 Previous Clinical Trials
1,280 Total Patients Enrolled
Nova Southeastern UniversityOTHER
99 Previous Clinical Trials
11,890 Total Patients Enrolled
Tony Zitek, MDPrincipal InvestigatorKendall Healthcare Group, Ltd.
5 Previous Clinical Trials
496 Total Patients Enrolled
1 Trials studying Headache
58 Patients Enrolled for Headache
~15 spots leftby Nov 2025
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