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Monoclonal Antibodies
Erenumab for Idiosyncratic Facial Pain
Phase 4
Waitlist Available
Led By David Jang, MD
Research Sponsored by David Jang, M.D.
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, 1, 3 and 6 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial tests a medication that is given regularly to people with facial pain or pressure but no sinusitis. The medication works by blocking pain signals to reduce discomfort.
Eligible Conditions
- Facial Pain
- Sinusitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1,3, and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1,3, and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Mean Number of Days Per Month With Significant Mid-facial Pain or Pressure
Secondary study objectives
Change From Baseline in Mean Daily Pain Score
Change in Emotional Function as Measured by Migraine Function Impact Questionnaire (MFIQ)
Change in Mean Number of Days Per Month With Significant Nasal Congestion
+7 moreAwards & Highlights
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.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ErenumabActive Control1 Intervention
140mg Erenumab administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months.
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered by subcutaneous injection (in the abdomen, thigh, or upper arm), once monthly for six months.
Find a Location
Who is running the clinical trial?
David Jang, M.D.Lead Sponsor
AmgenIndustry Sponsor
1,464 Previous Clinical Trials
1,401,048 Total Patients Enrolled
David Jang, MD4.76 ReviewsPrincipal Investigator - Duke Health
Duke University
5Patient Review
Dr. Jang is extremely knowledgable and kind. He listened to me attentively and described the procedure and every component in detail. He clearly cares a great deal about his patients' well-being and I would recommend him wholeheartedly.