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Monoclonal Antibodies

Erenumab 70 mg for Migraine

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
Eligibility criteria will be evaluated during the up to 3-week screening period (part 1) and a 4-week baseline period (part 2). At the end of baseline period, subjects who successfully met eligibility criteria will be randomized on study.
Age ≥ 18 years on entry into the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 4, 5, and 6 (weeks 13 through 24) of the dbtp
Awards & highlights

Study Summary

This trial will test whether erenumab is more effective than placebo at reducing the number of days with migraine for people with chronic migraine who have unsuccessfully tried other preventive treatments and have medication overuse headache.

Eligible Conditions
  • Migraine

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Before you can join the study, you will go through two periods of evaluation. The first one will take up to three weeks and the second one will take up to four weeks. If you meet the criteria at the end of the second period, you can join the study.
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You must be at least 18 years old to participate in the study.
Select...
You have had migraines with or without visual disturbances for at least a year, as defined by the International Classification of Headache Disorders.
Select...
You have tried at least one preventive treatment before but stopped taking it because it wasn't working, caused side effects, or you couldn't tolerate it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 4, 5, and 6 (weeks 13 through 24) of the dbtp
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 4, 5, and 6 (weeks 13 through 24) of the dbtp for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6
Secondary outcome measures
Change From Baseline in Mean Monthly AHMDs Over Months 4, 5, and 6
Change From Baseline in Mean Monthly Average Impact on Everyday Activities Domain Scores as Measured by the MPFID
Change From Baseline in Mean Monthly Average Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID)
+2 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Erenumab 70 mgActive Control1 Intervention
After participants complete the baseline period and are found eligible, they will be enrolled and randomized in a 1:1:1 ratio to either erenumab (70 mg or 140 mg) or placebo.
Group II: Erenumab 140 mgActive Control1 Intervention
After participants complete the baseline period and are found eligible, they will be enrolled and randomized in a 1:1:1 ratio to either erenumab (70 mg or 140 mg) or placebo.
Group III: PlaceboPlacebo Group1 Intervention
After participants complete the baseline period and are found eligible, they will be enrolled and randomized in a 1:1:1 ratio to either erenumab (70 mg or 140 mg) or placebo.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,355 Previous Clinical Trials
1,383,451 Total Patients Enrolled
18 Trials studying Migraine
8,808 Patients Enrolled for Migraine
MDStudy DirectorAmgen
899 Previous Clinical Trials
921,128 Total Patients Enrolled
18 Trials studying Migraine
8,808 Patients Enrolled for Migraine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other trials have occurred that employed the use of Erenumab 70 mg?

"Erenumab 70 mg was initially investigated at iResearch Savannah, LLC in 2019 and has since seen the completion of 18342 trials. Currently, Meridian, Idaho is home to a copious number of existing studies actively recruiting participants for their research."

Answered by AI

Are there any openings in the clinical trial that individuals can join?

"Allegedly, clinicaltrials.gov does not list this trial as presently recruiting participants. It was first posted on October 7th 2019 and last updated on June 17th 2022. However, there are several other trials currently enrolling patients with a total of 282 spots available for prospective volunteers."

Answered by AI

In which locales is this clinical trial presently functioning?

"Currently, this research is taking place in 24 different medical centres. Among those are sites based in Meridian, Tampa and Ann Arbor as well as other cities. It would be wise to choose the site closest to you if you decide to take part, so that travelling becomes less of a burden."

Answered by AI

Is this a pioneering venture in clinical research?

"Currently, there are 18 ongoing trials of Erenumab 70 mg spanning 179 cities and 32 countries. Since its first Phase 3 study in 2019 sponsored by Amgen, which included 456 patients, a total of 18342 studies have been conducted."

Answered by AI

To what extent is participation being sought in this research project?

"At this point, recruitment for the trial has been paused. Originally posted on October 7th 2019 and last edited June 17th 2022, potential participants should seek other clinical trials as there are currently 264 studies enrolling those with migraine and 18 examining Erenumab 70 mg."

Answered by AI

Are there any safety concerns related to administering Erenumab 70 mg?

"Despite being a Phase 4 study, our team at Power judged Erenumab 70 mg to be highly safe and awarded it with the maximum score of 3."

Answered by AI

Who meets the eligibility requirements for participating in this medical trial?

"This clinical trial seeks 620 people who suffer from migraine to participate. The age range required is 18-99 and the eligibility criteria will be evaluated during a three week screening period, followed by a four week baseline period. To meet the requirements, potential participants must have been dealing with migraines for at least one year prior to starting the study and have experienced treatment failure in regards to preventative treatments."

Answered by AI

Is this research study open to adults aged 40 years and older?

"The enrollment requirements for this trial dictate that participants must have reached the age of majority and be under 99 years old. There are 45 trials dedicated to minors, while 192 studies focus on seniors over 65."

Answered by AI

Who else is applying?

What state do they live in?
California
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Clinical Research Institute
~114 spots leftby Mar 2025