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Monoclonal Antibodies

Galcanezumab for Trigeminal Neuralgia

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, day 45, day 75 and day 105 for reporting.

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 • NCT04294147

16%

Constipation

Covid-19

100%

80%

60%

40%

20%

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

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