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Monoclonal Antibodies

Erenumab-Aooe 140 MG/ML [Aimovig] for Migraine

Phase 4
Waitlist Available
Led By Merle Diamond, MD
Research Sponsored by Merle Diamond
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 baseline and treatment months 1, 2, and 3
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

The purpose of this study is to assess the efficacy of erenumab on functional impact due to Migraine in adults.

Eligible Conditions
  • Migraine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and treatment months 1, 2, and 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and treatment months 1, 2, and 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Migraine Functional Impact Questionnaire (MFIQ) - "Overall Impact on Usual Activities" Scores at Baseline and at End of Treatment (Treatment Month 3).
Secondary study objectives
Brief Measure of Worry Severity (BMWS) Scores at Baseline and at Treatment Months 1, 2, and 3
General Self-Efficacy Severity Scale (GSESS) Scores at Baseline and at Treatment Months 1, 2, and 3.
Migraine Functional Impact Questionnaire (MFIQ) - "Impact on Emotional Function" Scores at Baseline and at Treatment Months 1, 2, and 3.
+15 more

Side effects data

From 2022 Phase 4 trial • 55 Patients • NCT04465357
5%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erenumab-Aooe 140 MG/ML [Aimovig]

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Erenumab-Aooe 140 MG/ML [Aimovig]Experimental Treatment1 Intervention
Participants received 140 mg/mL administered subcutaneously once every 4 weeks in the abdomen, thigh, or upper arm for three months (12 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erenumab
FDA approved

Find a Location

Who is running the clinical trial?

Merle DiamondLead Sponsor
Clinvest Research, LLCIndustry Sponsor
2 Previous Clinical Trials
204 Total Patients Enrolled
Smith, Timothy R., M.D.INDIV
1 Previous Clinical Trials
30 Total Patients Enrolled
~11 spots leftby Nov 2025
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