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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 4, 5, and 6 (weeks 13 through 24) of the dbtp

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 4, 5, and 6 (weeks 13 through 24) of the dbtp

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6

Secondary study objectives

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

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