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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

Study Summary

This trial will test a new drug for nerve pain in 20 patients. The goal is to reduce pain and need for rescue medication. The safety profile from previous trials in migraine patients will be monitored.

Eligible Conditions
  • Trigeminal Neuralgia
  • Glossopharyngeal Neuralgia

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in pain score
Change in use of rescue and other anti-pain medications
Number of adverse events, by type and severity
Secondary outcome measures
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
6%
Covid-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
140 mg Erenumab SC
240 mg Galcanezumab SC

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
~6760

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,497 Total Patients Enrolled
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,486 Total Patients Enrolled
Sweta Sengupta, MDPrincipal InvestigatorDuke University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being allocated to this clinical trial?

"Unfortunately, this clinical trial is no longer actively seeking participants; it was first listed on July 24th 2020 and last updated on the 13th of July 2022. Nevertheless, there are currently 257 studies involving trigeminal neuralgia that are recruiting patients as well as 6 trials for Galcanezumab looking to do the same."

Answered by AI

Has Galcanezumab been granted approval from the FDA?

"There is ample evidence of safety for Galcanezumab, so it has been assigned a score 3. This designation is due to this treatment's Phase 4 status which indicates that it has already received approval from regulatory bodies."

Answered by AI

Who is qualified to participate in this research project?

"To be eligible for this research study, applicants must possess a diagnosis of trigeminal neuralgia and fit the age criteria between 18-80 years old. Currently, there are approximately 20 available slots."

Answered by AI

Are there any other scholarly investigations that have focused on Galcanezumab?

"Currently, 6 trials concerning galcanezumab are running. Two of these live studies have reached Phase 3 and 330 clinical trial sites in Brookline, Massachusetts are participating in the research."

Answered by AI

Are individuals over the age of thirty eligible to participate in this research project?

"This study is open to those aged 18 to 80. For minors, there are 17 different trials available and 223 for seniors."

Answered by AI

Is this experimental research pioneering in its field?

"Eli Lilly and Company funded the initial investigation of Galcanezumab in 2018. This trial, which entailed 325 participants, served as a basis for Phase 3 drug approval. Currently, 11 nations are actively studying this medication with 6 trials active across 141 locations worldwide."

Answered by AI

Is this research effort actively seeking new participants?

"Unfortunately, recruitment for this trial is no longer possible as it was last modified on July 13th 2022. Luckily, there are currently 257 clinical trials recruiting patients with trigeminal neuralgia and 6 studies that use Galcanezumab to treat the condition."

Answered by AI

Who else is applying?

What state do they live in?
New York
Georgia
Massachusetts
Other
How old are they?
18 - 65
What site did they apply to?
Duke University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

i have had trigeminal neuralgia since i was 24 years. The medications that they put me on made me like a zombie. i have been controlling it with acupuncture. i have been in remission for years but in the last two years i have been getting twinges and pain aching in my face and throat and eye, head the whole thing. it scares me to think how bad the pain can become. i have been hospitalized for this at UNC Chapel Hill for a week. sent me home with a huge box of pills and i couldnt function either way. not on the meds and on the meds. im very nervous that it will be returning full force because im going through a very difficult time in my life; my husband of 32 years is divorcing me and im an empty nester. i have bipolar and have just been diagnosed with major depressive disorder. i think im a good candidate for this trial because i have a mixture of pain as i write this i want to bash my teeth out on the left they ache so bad. thank you for your time and consideration.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

how long do screen times take? How many people will be in this trial and how long has this medication been around? what sort of possible side affects can i expect?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Duke University: < 24 hours
Average response time
  • < 1 Day
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~4 spots leftby Apr 2025
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