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Monoclonal Antibodies
Efficacy of Erenumab on Functional Impact of 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and treatment months 1, 2, and 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and treatment months 1, 2, and 3
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 moreSide effects data
From 2022 Phase 4 trial • 55 Patients • NCT044653575%
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
Merle Diamond, MD4.115 ReviewsPrincipal Investigator - Diamond Headache Clinic
Diamond Headache Clinic
1 Previous Clinical Trials
150 Total Patients Enrolled
5Patient Review
Dr. Diamond is an excellent physician; I've been seeing her for over five years. She's great at communicating and taking the time to get to know me and my situation. She's also extremely knowledgeable when it comes to headaches — I feel very lucky to have her as my doctor. I wouldn't hesitate to recommend her.