Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473597
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-19
Brief Title:
A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache
Sponsor:
Antonios Likourezos
Organization:
Maimonides Medical Center
Study Overview
Official Title:
A Comparison of Rimegepant Orally Disintegrating Tablet Nurtec ODT to Rizatriptan Benzoate Orally Disintegrating Tablet Maxalt MLT-ODT in Adult Patients Presenting to the ED With Migraine Headache Randomized Double-Blind Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rimegepant Nurtec is an orally administered small molecule CGRP receptor antagonist with efficacy in the acute treatment of migraine Rizatriptan benzoate MAXALT is a selective 5-hydroxytryptamine1B1D 5-HT1B1D receptor agonist Rizatriptan binds with high affinity to human cloned 5-HT1B and 5-HT1D receptors which leads to activation of these receptors results in cranial vessel constriction inhibition of neuropeptide release and reduced transmission in trigeminal pain pathways with resultant relieve of the headache
Teh investigators hypothesize that the administration of Rimegepant ODT would provide better analgesic efficacy than Rizatriptan ODT with respect to analgesic efficacy at 60 min and 120 minutes in ED patients with acute headache
This is a prospective randomized double-blind superiority trial evaluating and comparing analgesic efficacy and safety of Rimegepant ODT 75 mg to Rizatriptan ODT 10 mg in adult patients presenting to the Emergency Department of Maimonides Medical Center with acute migraine headache
Teh investigators hypothesize that the administration of Rimegepant ODT would provide better analgesic efficacy than Rizatriptan ODT with respect to analgesic efficacy at 60 min and 120 minutes in ED patients with acute headache
This is a prospective randomized double-blind superiority trial evaluating and comparing analgesic efficacy and safety of Rimegepant ODT 75 mg to Rizatriptan ODT 10 mg in adult patients presenting to the Emergency Department of Maimonides Medical Center with acute migraine headache
Detailed Description:
This is a prospective randomized double-blind superiority trial evaluating and comparing analgesic efficacy and safety of Rimegepant ODT 75 mg to Rizatriptan ODT 10 mg in adult patients presenting to the ED of Maimonides Medical Center with acute migraine headache
The investigators will conduct the study in the emergency department of Maimonides Medical Center an urban emergency department that receives over 120000 adult visits annually The emergency department is staffed on weekdays by salaried trained bilingual English and Spanish research associates who execute research studies under the supervision of the principal investigators Adult patients between ages of 18 and 65 presenting to the ED with an acute exacerbation of a migraine without aura as defined by the International Classification of Headache Disorders 3rd edition criteria for migraine without aura or for probable migraine without aura with 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 will be eligible for participation Subjects 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
Each patient will be approached by research associates 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 participants primary language a language- appropriate consent form will be used and non-investigator hospital-employed trained interpreters or licensed telephone interpreter 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
Research associates will ascertain the subjects headache level every 30 minutes after medication administration for up to 120 minutes If enrolled subjects required more pain medication at or after one hour had elapsed they will be given additional medication at the discretion of the treating physician
The research team will be contacting all of research subjects by telephone 24 hours after ED discharge to ascertain headache status satisfaction with treatment and presence of adverse events
All data will be recorded on data collection sheets including patients sex demographics medical history and vital signs and entered into SPSS version 240 IBM Corp by the research manager Confirmation of written consent acquisition for all participants and statistical analyses will be conducted by the institutional biostatistician who will work independently of any data collection
As a primary measure of headache intensity the investigators utilized a standard validated and reproducible 11-point numerical rating scale NRS This scale uses patients responses in assigning their pain a number between 0 and 10 with 0 representing no pain and ten representing the worst pain imaginable Secondary measurement scales included a standard four-point pain intensity categorical scale in which patients describe their pain as severe moderate mild or none and a four-point functional disability scale in which patients describe their headache-related disability as severe cannot get up from bed or stretcher moderate great deal of difficulty doing what I usually do and can only do very minor activities mild little bit of difficulty doing what I usually do or none These scales will be used in accordance with the recommendation by the International Headache Society for use in migraine research
One hour after medication administration the investigators will ask all of enrolled patients if they needed more medication for pain Lastly we will assess enrolled patients satisfaction efficacy and tolerability of the study drug with treatment by asking each of them 24 hours after enrollment whether they would want to receive the same medication the next time they visited the ED with an acute migraine
The primary outcome for this study will be a comparison of change in numerical rating scale score between baseline and one hour between two investigational arms
Secondary outcomes will include
1 A comparative change in pain score between two groups at 120 minutes
2 A frequency of rescue analgesia at 60 and 120 minutes
3 Sustained headache freedom defined as achieving a level of none on the severe moderate mild and none scale within 2 hours of investigational medication administration and maintaining this level continuously for 24 hours without use of rescue medication
4 Sustained headache relief defined as change within 2 hours of the patients description of headache from severe or moderate to either mild or none without use of rescue medication and maintaining this level of relief continuously for 24 hours
5 Headache relief in the ED defined as change within 2 hours of the patients description of headache from severe or moderate to either mild or none without the use of rescue medication
6 Headache freedom in the ED defined as achieving a headache level of none within 2 hours without use of rescue medication
7 Achieving a normal functional status by two hours
8 The patients overall assessment of efficacy and tolerability expressed as a dichotomous response to the question Do you want to receive the same medication the next time you visit the ER with a migraine
The investigators will conduct the study in the emergency department of Maimonides Medical Center an urban emergency department that receives over 120000 adult visits annually The emergency department is staffed on weekdays by salaried trained bilingual English and Spanish research associates who execute research studies under the supervision of the principal investigators Adult patients between ages of 18 and 65 presenting to the ED with an acute exacerbation of a migraine without aura as defined by the International Classification of Headache Disorders 3rd edition criteria for migraine without aura or for probable migraine without aura with 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 will be eligible for participation Subjects 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
Each patient will be approached by research associates 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 participants primary language a language- appropriate consent form will be used and non-investigator hospital-employed trained interpreters or licensed telephone interpreter 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
Research associates will ascertain the subjects headache level every 30 minutes after medication administration for up to 120 minutes If enrolled subjects required more pain medication at or after one hour had elapsed they will be given additional medication at the discretion of the treating physician
The research team will be contacting all of research subjects by telephone 24 hours after ED discharge to ascertain headache status satisfaction with treatment and presence of adverse events
All data will be recorded on data collection sheets including patients sex demographics medical history and vital signs and entered into SPSS version 240 IBM Corp by the research manager Confirmation of written consent acquisition for all participants and statistical analyses will be conducted by the institutional biostatistician who will work independently of any data collection
As a primary measure of headache intensity the investigators utilized a standard validated and reproducible 11-point numerical rating scale NRS This scale uses patients responses in assigning their pain a number between 0 and 10 with 0 representing no pain and ten representing the worst pain imaginable Secondary measurement scales included a standard four-point pain intensity categorical scale in which patients describe their pain as severe moderate mild or none and a four-point functional disability scale in which patients describe their headache-related disability as severe cannot get up from bed or stretcher moderate great deal of difficulty doing what I usually do and can only do very minor activities mild little bit of difficulty doing what I usually do or none These scales will be used in accordance with the recommendation by the International Headache Society for use in migraine research
One hour after medication administration the investigators will ask all of enrolled patients if they needed more medication for pain Lastly we will assess enrolled patients satisfaction efficacy and tolerability of the study drug with treatment by asking each of them 24 hours after enrollment whether they would want to receive the same medication the next time they visited the ED with an acute migraine
The primary outcome for this study will be a comparison of change in numerical rating scale score between baseline and one hour between two investigational arms
Secondary outcomes will include
1 A comparative change in pain score between two groups at 120 minutes
2 A frequency of rescue analgesia at 60 and 120 minutes
3 Sustained headache freedom defined as achieving a level of none on the severe moderate mild and none scale within 2 hours of investigational medication administration and maintaining this level continuously for 24 hours without use of rescue medication
4 Sustained headache relief defined as change within 2 hours of the patients description of headache from severe or moderate to either mild or none without use of rescue medication and maintaining this level of relief continuously for 24 hours
5 Headache relief in the ED defined as change within 2 hours of the patients description of headache from severe or moderate to either mild or none without the use of rescue medication
6 Headache freedom in the ED defined as achieving a headache level of none within 2 hours without use of rescue medication
7 Achieving a normal functional status by two hours
8 The patients overall assessment of efficacy and tolerability expressed as a dichotomous response to the question Do you want to receive the same medication the next time you visit the ER with a migraine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None