- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04860713
An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute Headache
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
-
Brooklyn, New York, United States, 11219
- Maimonides Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: AOK Group
Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin
|
Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin
|
Active Comparator: Nurtec (Rimegepant) Group
Drug: 75 mg of ODT
|
Drug: 75 mg of ODT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
60 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leily Naraghi, MD, Maimonides Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Headache
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Ketamine
- Aspirin
Other Study ID Numbers
- 2021-02-03-MMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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