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

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Antonios Likourezos
Study ID
NCT04860713
Phase
PHASE4
Status
Completed

Conditions

  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • aspirin and ketamine — DRUG
    Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin
  • Nurtec (Rimegepant) — DRUG
    Drug: 75 mg of ODT

Study Details

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.

Key Dates

Start date
Apr 22, 2021
Status verified
Nov 2022
Primary completion
Sep 30, 2022
Completion
Nov 17, 2022

Study Design

Enrollment
5 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: AOK Group
    Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin
  • Active Comparator: Nurtec (Rimegepant) Group
    Drug: 75 mg of ODT

Primary Outcome Measure

Change in Pain Score at 60 Minutes [ Time Frame: 60 minutes ]

Locations (1)

FacilityCityStateZIPSite coordinators
Maimonides Medical CenterBrooklynNew York11219-

Find similar trials in Brooklyn, NY

By research site
Maimonides Medical Center· Brooklyn, NY

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