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

This prospective, randomised, open-label trial (n=5) compared the analgesic efficacy and safety of a proprietary formulation of orally administered aspirin and ketamine (AOK) to Nurtec (Rimegepant) in adult patients presenting to the Emergency Department (ED) with acute headache.

Patients aged 18 and older with an initial pain score of 5 or more on a standard 11-point numeric rating scale were included. The trial, led by Antonios Likourezos, aimed to determine if AOK provides similar analgesia to Nurtec at 60 minutes post-medication administration.

The study began in April 2021 and concluded in November 2022 at Maimonides Medical Center, Brooklyn, New York. Patients were randomised into two groups: Group I received AOK, while Group II received Nurtec.

Primary outcomes included a comparative reduction in pain scores at 60 minutes post-administration. Secondary outcomes comprised the need for rescue analgesia, rates of adverse effects, and change in pain score up to 120 minutes.

Data collection involved patient assessment, vital signs monitoring, and adverse effects evaluation.

Topic Headache Disorders
Compound Ketamine
Country United States of America
Visit trial

Trial Details



Trial Number

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.