CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 5 enrolled
Drug / intervention
aspirin and ketamine +1 moredrug
Likely dose
aspirin and ketamine 0.85mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04860713
NCT04860713Phase 4Completed

An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin and Nurtec (Rimegepant) in Adult Patients Presenting to the ED With Acute Headache: Prospective, Randomized, Open-Label, Clinical Trial

Antonios Likourezos·interventional·Posted Apr 27, 2021·Updated Jan 31, 2024

In Brief

A Phase 4 clinical trial evaluating aspirin and ketamine and Nurtec (Rimegepant) for Pain. Completed, enrolled 5 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedApr 27, 2021
Enrollment StartApr 22, 2021
Primary CompletionSep 30, 2022
Study CompletionNov 17, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.2 years ago

Interventions

aspirin and ketaminedrug

Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin

Nurtec (Rimegepant)drug

Drug: 75 mg of ODT