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

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ClinicalTrials.gov Identifier: NCT04860713
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : February 17, 2022
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Drug: aspirin and ketamine Drug: Nurtec (Rimegepant) Phase 4

Detailed Description:

STUDY OBJECTIVES: To compare analgesic efficacy and rates of side effects of a proprietary formulation of orally administered aspirin and ketamine (AOK) to a Nurtec ODT (Rimegepant) for pain management in adult ED patients presenting to the ED with acute headache.

HYPOTHESIS: We hypothesize that the administration of AOK will provide similar analgesia at 60 minutes post-administration in comparison to Nurtec (Rimegepant) in adult patients presenting to the ED with acute headache. The primary outcome of this trial is the difference in participant's pain scores at 60 minutes post-medication administration.

STUDY DESIGN:

Subjects:

Patients 18 years of age and older presenting to the ED with acute headache (defined as HA lasting no more than 1 week) and an initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating scale and requiring oral analgesia as determined by the treating attending physician. Patients' screening and enrollment will be performed by study investigators and research assistants. All patients will be enrolled at various times of the day when study investigators will be available for patient enrollment and an ED pharmacist will be available for medication preparation.

Design: This is a prospective, randomized, open-label, equivalence trial comparing analgesic efficacy and safety of AOK and Nurtec (Rimegepant) in patients presenting to the ED of Maimonides Medical Center with acute headache. Upon meeting the eligibility criteria, patients will be randomized into one of the two study arms: Group I will receive AOK, and Group II will receive Nurtec.

Data Collection Procedures: Each patient will be approached by a study investigator for acquisition of written informed consent and Health Insurance Portability and Accountability Act authorization after being evaluated by the treating emergency physician and determined to meet study eligibility criteria. When English will not be the participant's primary language, a language- appropriate consent form will be used and non-investigator, hospital employed, trained interpreters or licensed telephone interpreters will assist in acquisition of informed consent. Baseline pain score will be determined with an 11-point numeric rating scale (0 to 10), described to the patient as "no pain" being 0 and "the worst pain imaginable" being 10. A study investigator will record the patient's body weight and baseline vital signs. All data will be recorded on data collection sheets, including patients' sex, demographics, medical history, and vital signs, and entered into SPSS (version 24.0; IBM Corp) by the research manager. Confirmation of written consent acquisition for all participants, and statistical analyses will be conducted by the statistician, who will work independently of any data collection.

Expected Outcomes: The primary outcome will include a comparative reduction of pain scores on numeric rating pain scale (NRS) at 60 minutes from the baseline. The secondary outcomes will include a need for rescue analgesia, rates of adverse effects and change in pain score up to 120 minutes. With respect to unique adverse effects of ketamine, we will use Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) and Richmond Agitation Sedation Scale (RASS) (ref) SERSDA Scale includes fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing, mood change, general discomfort, and hallucinations with severity of each graded by patients on a five-point scale, with "0" representing the absence of any adverse effects and "4" representing a severely bothersome side effect. RASS evaluates the severity of agitation and/or sedation in accordance with the nine-point scale with scores ranging from "-4" (deeply sedated) to "0" (alert and calm) to "+4" (combative).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: AOK Group
Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin
 Drug: aspirin and ketamine
Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin
Active Comparator: Nurtec (Rimegepant) Group
Drug: 75 mg of ODT
 Drug: Nurtec (Rimegepant)
Drug: 75 mg of ODT


Outcome Measures
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Primary Outcome Measures :
  1. Change in Pain score at 60 minutes [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04860713


Contacts
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Contact: Antonios Likourezos, MA, MPH 7182836896 alikourezos@maimonidesmed.org
Contact: Leily Naraghi, MD LNaraghi@maimonidesmed.org

Locations
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United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Antonios Likourezos, MA, MPH       alikourezos@maimonidesmed.org   
Contact: Sergey Motov, MD       smotov@maimonidesmed.org   
Sponsors and Collaborators
Antonios Likourezos
Investigators
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Principal Investigator: Leily Naraghi, MD Maimonides Medical Center
  Study Documents (Full-Text)

Documents provided by Antonios Likourezos, Maimonides Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] March 23, 2021

More Information
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Responsible Party: Antonios Likourezos, Research Administration Director, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT04860713    
Other Study ID Numbers: 2021-02-03-MMC
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonios Likourezos, Maimonides Medical Center:
Emergency Medicine
Pain
Pain Management
Acute Headache
Additional relevant MeSH terms:
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Headache
Pain
Neurologic Manifestations
Aspirin
Ketamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
 Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents