Trigeminal NeuralgiaPhase 4NCT04158752

Anti-CGRP for Inflammation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia

A Phase 4 study testing Galcanezumab in people with Trigeminal Neuralgia and Glossopharyngeal Neuralgia, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators will treat patients (targeting enrollment of n=20) who suffer from trigeminal or glossopharyngeal nerve pain in the context of painful small fiber neuropathy. The primary pain-related objective is reduction of pain and reduced use of rescue and other anti-pain medications. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Trigeminal Neuralgia, Glossopharyngeal Neuralgia
What is being tested?: Galcanezumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 24 Jul 2020to 4 Jan 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-80 years old.
The patient must have an assigned diagnosis of non-neuralgic trigeminal nerve pain G50.1, with all its permutations listed in the ICD10 explicitly allowed. Co-morbid trigeminal neuralgia G50.0 and G43. … related headache codes are allowed. As an alternative to trigeminal nerve pain G50.1, glossopharyngeal nerve pain will be another inclusion criterion, with a G52.1 diagnosis and explicit mentioning of pain mediated by or in the innervation territory of the glossopharyngeal nerve.
In addition, patients have to be diagnosed with a painful small fiber neuropathy. This diagnosis is based on a skin biopsy or biopsy of an innervated surface epithelium with nerve fiber density count. The required ICD10 diagnostic codes are G63.3, G60.8, G62.8. Co-morbidity with a fibromyalgia-related disorder will be allowed, typically summarized under a diagnosis code of M79.7.

Who cannot join

Patients that have a history of allergy or allergy-like incompatibility with a biologic that contains a human or humanized monoclonal antibody will be excluded.
Female patients of child-bearing age who are or want to become pregnant will be excluded. In case such a patient intends to participate, then she has to commit to a pregnancy prevention regimen that is based on hormonal contraceptive or intra-uterine device.

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University
Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: Anti-CGRP Neutralizing Antibody for Modulation of Neurogenic Inflammation in Trigeminal and Glossopharyngeal Pain Associated With Small Fiber Neuropathy/Fibromyalgia

Conditions: Trigeminal Neuralgia, Glossopharyngeal Neuralgia
Being tested: Galcanezumab
Medical subject headings: Trigeminal Neuralgia, Glossopharyngeal Nerve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GalcanezumabDrug
Injection of study drug at 3 timepoints (day 30, day 60, day 90)

Study groups in NCT04158752
Study group	Role	What they receive
Open Label Galcanezumab	Experimental	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. Receives: Drug: Galcanezumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Pain Score
Patient reported 0-10 analog pain scale, where 0 = no pain and 10 = worst pain imaginable. Reported as the change between timepoints.
Measured: Baseline (day 0), 45, 60, 75, 90, 105, 135, and 180 days
Number of Participants With a Change in Use of Anti-pain Medication
Patient reported; any use of anti-pain medication.
Measured: Baseline through Day 135
Total Number of Adverse Events by Severity
Recording all potential adverse events, based on lab results, patient side effects logs, patient vital sign measurement, and medical record review. Adverse events can be classified into five severity grades (1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death).
Measured: Collected through Day 180

Secondary outcomes (2)

Change in Level of TNF-alpha as a Marker of Pain or Inflammation
Blood testing for presence of cytokine/chemokine pain or inflammation markers in patients' serum
Measured: Baseline, Day 180
Change in Level of IL-6 as a Marker of Pain or Inflammation
Blood testing for presence of cytokine/chemokine pain or inflammation markers in patients' serum
Measured: Baseline, Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jul 20204 Jan 2023

First posted12 Nov 2019
Study start24 Jul 2020
Primary completion4 Jan 2023
Study completion4 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04158752
Sponsor's protocol ID: Pro00103776
Status last verified: Jan 2026
First submitted: 30 Oct 2019
Last updated: 2 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Trigeminal Neuralgia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Anti-CGRP Neutralizing Antibody for Modulation of Neurogenic Inflammation in Trigeminal and Glossopharyngeal Pain Associated With Small Fiber Neuropathy/Fibromyalgia
ClinicalTrials.gov ID: NCT04158752
Acronym / sponsor ID: Pro00103776
Conditions: Trigeminal Neuralgia, Glossopharyngeal Neuralgia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Eli Lilly and Company
Study start: 24 Jul 2020 (actual)
Primary completion: 4 Jan 2023 (actual)
Study completion: 4 Jan 2023 (actual)
First posted: 12 Nov 2019 (actual)
Results: Posted 2 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open Label Galcanezumab	Experimental	Drug: GalcanezumabParticipants 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age 18-80 years old.
The patient must have an assigned diagnosis of non-neuralgic trigeminal nerve pain G50.1, with all its permutations listed in the ICD10 explicitly allowed. Co-morbid trigeminal neuralgia G50.0 and G43. … related headache codes are allowed. As an alternative to trigeminal nerve pain G50.1, glossopharyngeal nerve pain will be another inclusion criterion, with a G52.1 diagnosis and explicit mentioning of pain mediated by or in the innervation territory of the glossopharyngeal nerve.
In addition, patients have to be diagnosed with a painful small fiber neuropathy. This diagnosis is based on a skin biopsy or biopsy of an innervated surface epithelium with nerve fiber density count. The required ICD10 diagnostic codes are G63.3, G60.8, G62.8. Co-morbidity with a fibromyalgia-related disorder will be allowed, typically summarized under a diagnosis code of M79.7.

Key exclusion criteria (2 listed)

Patients that have a history of allergy or allergy-like incompatibility with a biologic that contains a human or humanized monoclonal antibody will be excluded.
Female patients of child-bearing age who are or want to become pregnant will be excluded. In case such a patient intends to participate, then she has to commit to a pregnancy prevention regimen that is based on hormonal contraceptive or intra-uterine device.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GalcanezumabInjection of study drug at 3 timepoints (day 30, day 60, day 90)	Drug	Open Label Galcanezumab

Primary outcome

Change in Pain Score
Time frame: Baseline (day 0), 45, 60, 75, 90, 105, 135, and 180 days
Patient reported 0-10 analog pain scale, where 0 = no pain and 10 = worst pain imaginable. Reported as the change between timepoints.
Number of Participants With a Change in Use of Anti-pain Medication
Time frame: Baseline through Day 135
Patient reported; any use of anti-pain medication.
Total Number of Adverse Events by Severity
Time frame: Collected through Day 180
Recording all potential adverse events, based on lab results, patient side effects logs, patient vital sign measurement, and medical record review. Adverse events can be classified into five severity grades (1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death).

2 secondary outcomes

Change in Level of TNF-alpha as a Marker of Pain or Inflammation
Time frame: Baseline, Day 180
Change in Level of IL-6 as a Marker of Pain or Inflammation
Time frame: Baseline, Day 180

Results and safety

Results posted to the registry on 2 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open Label Galcanezumab	20	18

Primary outcome: Change in Pain Score

Time frame: Baseline (day 0), 45, 60, 75, 90, 105, 135, and 180 days. Mean (Standard Error). Unit: score on a scale

Measure	Open Label Galcanezumab n = 20
Change from baseline to 60 days	-0.6224 (0.2663)
Change from baseline to 90 days	-1.005 (0.2759)
Change from baseline to 135 days	-0.8102 (0.2576)
Change from baseline to 180 days	-1.079 (0.3816)
Change from 45 days to 90 days	-0.3827 (0.2995)
Change from 45 days to 135 days	-0.1877 (0.2796)
Change from 45 days to 180 days	-0.4566 (0.3887)
Change from 75 days to 135 days	0.1949 (0.2876)

Primary outcome: Number of Participants With a Change in Use of Anti-pain Medication

Time frame: Baseline through Day 135. Count of participants. Unit: Participants

Measure	Open Label Galcanezumab n = 18
Added one or more anti-pain medication	3
Stopped one or more anti-pain medication	4
No change	13

Population analysed: Data not collected on two participants who withdrew from the study. Two participants stopped one medication and started another.

Primary outcome: Total Number of Adverse Events by Severity

Time frame: Collected through Day 180. Number. Unit: adverse events

Measure	Open Label Galcanezumab n = 20
1 = mild	29
2 = moderate	5
3 = severe	0
4 = life threatening	0
5 = death	0

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 180 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open Label Galcanezumab	0 of 20 (0%)	13 of 20 (65%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sweta Sengupta, MD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Galcanezumab in people with Trigeminal Neuralgia and Glossopharyngeal Neuralgia, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Score (time frame: Baseline (day 0), 45, 60, 75, 90, 105, 135, and 180 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04158752.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.