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Monoclonal Antibodies
Anti-CGRP for Inflamation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia
Phase 4
Waitlist Available
Led By Sweta Sengupta, MD
Research Sponsored by Duke University
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 day 0, day 45, day 75 and day 105
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to test a migraine medication on people with nerve pain to see if it reduces their pain and need for other painkillers. The study will also check if the medication is safe for these people.
Eligible Conditions
- Trigeminal Neuralgia
- Glossopharyngeal Neuralgia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0, day 45, day 75 and day 105
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, day 45, day 75 and day 105
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in pain score
Change in use of rescue and other anti-pain medications
Number of adverse events, by type and severity
Secondary study objectives
Change in circadian rhythm impairment
Change in subject's pain/inflammation markers
Presence or absence of DNA polymorphisms that predispose treated patients to accentuated responses of either lack of response or particularly potent response
Side effects data
From 2021 Phase 4 trial • 65 Patients • NCT0429414716%
Constipation
6%
Covid-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
140 mg Erenumab SC
240 mg Galcanezumab SC
Awards & Highlights
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: Open Label GalcanezumabExperimental Treatment1 Intervention
Participants will receive their 1st injectable dose during the Day 30 visit. Participants will then inject themselves at home on Day 60 and again on Day 90.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Galcanezumab
2015
Completed Phase 4
~6750
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyIndustry Sponsor
2,679 Previous Clinical Trials
3,465,733 Total Patients Enrolled
Duke UniversityLead Sponsor
2,458 Previous Clinical Trials
2,969,429 Total Patients Enrolled
Sweta Sengupta, MDPrincipal InvestigatorDuke University