drugset / Trial / NCT04860713

An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache

NCT04860713

Phase 4 Completed 5 enrolled Antonios Likourezos
RandomizedParallel-groupOpen-labelTreatment

Summary

Headaches affect over 50% of patients annually, with close to 4% of ED visits for headache. Most headaches managed in the ED are benign, with 90% of these headaches classified as tension, migraine, or cluster. At present, the satisfaction with ED treatment of headache is low, and despite the multitude of available medications, the evidence- based treatment options are often quite limited. There are over twenty different types of medications available to the ED clinicians for managing headache, many with different routes of administration (parenteral, intranasal, subcutaneous, and oral). Many of these medications are provided in so-called "headache cocktail", which varies based on the physician, institution, and patient preferences.

Timeline

Start
2021-04-22
Primary completion
2022-09-30
Completion
2022-11-17

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 324 mg Oral
Comparator Ketamine Small molecule 0.85 mg/kg Oral
Comparator Rimegepant Small molecule 75 mg

Indications

No indication recorded.