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

NCT04860713 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2021-02-03-MMC
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

Emergency Medicine; Pain; Pain Management; Acute Headache

Outcome Measures

Primary Outcomes (1)

• Change in Pain Score at 60 Minutes

  Change of pain scores on numeric rating pain scale (NRS) at 60 minutes mark form the baseline. The NRS is an 11 item Likert Scale ranging from 0 (no pain) to 10 (very severe pain) with 5 indicating moderate pain.

  60 minutes

Study Arms (2)

AOK Group

ACTIVE COMPARATOR

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

Drug: aspirin and ketamine

Nurtec (Rimegepant) Group

ACTIVE COMPARATOR

Drug: 75 mg of ODT

Drug: Nurtec (Rimegepant)

Interventions

aspirin and ketamine DRUG

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

AOK Group

Nurtec (Rimegepant) DRUG

Drug: 75 mg of ODT

Nurtec (Rimegepant) Group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18 and older
• Acute Headache
• Initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.
• Awake, alert, and oriented to person, place, and time

You may not qualify if:

• altered mental status,
• allergy to aspirin, ketamine and rimegepant,
• pregnancy and breastfeeding
• unstable vital signs (systolic blood pressure \<90 or\>180 mm Hg, pulse rate \<50 or \>150 beats/ min, and respiration rate \<10 or \>30 breaths/min)
• inability to provide consent
• consumption of Aspirin or NSAID's within 6 hours of arrival to the ED or acetaminophen within 4 hours of arrival
• active PUD
• history of GI Hemorrhage
• history of renal and hepatic insufficiency
• past medical history of alcohol or drug abuse
• schizophrenia
• clinical findings concerning for acute intracranial process, acute infections process

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Aspirin; Ketamine; rimegepant sulfate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Results Point of Contact

• Title: Research Administration Director
• Organization: Maimonides Medical Center

alikourezos@maimonidesmed.org

718-283-6896

Study Officials

• Leily Naraghi, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Administration Director

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: April 22, 2021
• Primary Completion: September 30, 2022
• Study Completion: November 17, 2022
• Last Updated: January 31, 2024
• Results First Posted: January 31, 2024

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)