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Monoclonal Antibodies
Erenumab for Migraine (EMBRACE Trial)
Phase 4
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over months 1, 2, and 3
Awards & highlights
EMBRACE Trial Summary
This trial is testing a new drug to see if it can help reduce the duration of headaches that are of at least moderate pain intensity.
Eligible Conditions
- Migraine
EMBRACE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over months 1, 2, and 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over months 1, 2, and 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in mean monthly hours of at least moderate headache pain intensity, with pain intensity measured by the 11-point NRS scale
Secondary outcome measures
Change from baseline in mean monthly average duration of at least moderate pain intensity in qualifying migraine attacks, with pain measured by the 11-point NRS scale
Change from baseline in mean monthly average peak migraine pain intensity as assessed by the 11-point Numeric Rating Scale (NRS)
Change from baseline in mean monthly physical function domain score as measured by the Migraine Functional Impact Questionnaire (MFIQ)
+3 moreSide effects data
From 2023 Phase 4 trial • 701 Patients • NCT0408431435%
COVID-19
19%
Nasopharyngitis
15%
Constipation
9%
Fatigue
7%
Hypertension
6%
Depression
6%
Back pain
6%
Immunisation reaction
6%
Headache
6%
Migraine
5%
Nausea
5%
Arthralgia
4%
Vertigo
4%
Alopecia
4%
Pain in extremity
3%
Tonsillitis
3%
Cystitis
3%
Urinary tract infection
3%
Oropharyngeal pain
3%
Dizziness
3%
Cough
3%
Chills
3%
Pruritus
3%
Pyrexia
2%
Diarrhoea
2%
Post vaccination fever
2%
Abdominal pain upper
2%
Muscle spasms
2%
Osteoarthritis
2%
Procedural pain
1%
Appendicitis
1%
Intervertebral disc protrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erenumab
EMBRACE Trial Design
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
The 4-month DBTP has 2 phases:
Main DBTP (M-DBTP, months 1 to 3) that will assess the effect of erenumab on metrics such as time spent in at least moderate pain, peak migraine severity, and functional impairment.
Exploratory DBTP (E-DBTP, month 4) that will assess the impact of erenumab on the acute response to treatment with oral triptan therapy as well as non-ictal burden.
Group II: ErenumabExperimental Treatment1 Intervention
The 4-month DBTP has 2 phases:
Main double-blind treatment phase (M-DBTP, months 1 to 3) that will assess the effect of erenumab on metrics such as time spent in at least moderate pain, peak migraine severity, and functional impairment.
Exploratory DBTP (E-DBTP, month 4) that will assess the impact of erenumab on the acute response to treatment with oral triptan therapy as well as non-ictal burden.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erenumab
2016
Completed Phase 4
~7860
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,176 Total Patients Enrolled
18 Trials studying Migraine
8,917 Patients Enrolled for Migraine
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,619 Total Patients Enrolled
18 Trials studying Migraine
8,917 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with migraine headaches for at least a year.You cannot take oral triptans due to medical reasons.You have already been treated with erenumab.I'm sorry, but "Key" is not a criterion. It does not provide enough information to understand what the exclusion criteria are for the clinical trial.You have a history of severe headaches that affect one side of your head and may be accompanied by other symptoms.You have tried at least four different medications for your condition, but none of them have worked.You have tried at least one medication to prevent migraines in the past, but it did not work well for you.You are currently taking lasmiditan or a gepant for immediate treatment.You have experienced at least 4 moderate to severe migraine attacks every month for the past 3 months.You have a history of migraine with at least 7 to 15 headache days per month during the 3 months prior to screening.You have taken a medication called gepant to prevent migraines before. If you did not respond to the medication, stopped taking it within the last 12 weeks, or had a negative reaction to the medication, you cannot participate.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Erenumab
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA confirmed Erenumab as a legitimate therapeutic remedy?
"Data from prior studies affirm the safety of Erenumab, so it was awarded a score of 3."
Answered by AI
Is the enrollment period still active for this research project?
"Affirmative, the details accessible on clinicaltrials.gov prove that this experiment is in its enrolment stage. The trial was launched on September 15th 2020 and has since been updated as recently as November 18th 2022. As of now, 576 subjects are being sought from 16 different centres."
Answered by AI
Is this an innovative clinical trial?
"Currently, Erenumab is being trialed in 179 cities across 32 countries. The initial trial for the drug was conducted by Amgen and completed its Phase 3 approval stage with 456 patients in 2019; since then, a further 18343 studies have been finalized."
Answered by AI
Are there multiple locations executing this experiment in the area?
"Visionary Investigators Network in Miami, Florida, JEM Research Institute in Pembroke Pines, Massachusetts and Saint Lukes Clinic in Atlantis, Ohio are the primary medical centres involved with this trial. Additionally 16 other locations are also participating."
Answered by AI
Has Erenumab been investigated in previous research efforts?
"Currently, 18 clinical trials related to Erenumab are underway. 3 of those experiments have reached the Phase 3 stage. Although most of the research takes place in Rochester, Minnesota, there are 549 medical centres that are running these tests across America."
Answered by AI
What is the capacity of this trial in regards to participant enrollment?
"To properly conduct this research, Amgen requires 576 individuals who meet the given eligibility requirements. To facilitate the trial, they have partnered with Visionary Investigators Network in Miami and JEM Research Institute in Pembroke Pines."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
South Carolina
Florida
How old are they?
18 - 65
What site did they apply to?
Visionary Investigators Network
Palmetto Clinical Trial Services LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
I would like to contribute to migraine research as someone who understands the struggle.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
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