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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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. Another goal is to monitor and confirm the safety profile established in the migraine population, during previous Phase 3 trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galcanezumab | Drug | Injection of study drug at 3 timepoints (day 30, day 60, day 90) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). | Collected through Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Day 180 |
| Change in Level of IL-6 as a Marker of Pain or Inflammation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Circadian Rhythm Impairment | Based on data from Wearable Sleep Monitor | Daily, from Baseline through Day 180 |
| Presence or Absence of DNA Polymorphisms That Predispose Treated Patients to Accentuated Responses of Either Lack of Response or Particularly Potent Response |
Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sweta Sengupta, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
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Of the 26 enrolled, 20 patients met inclusion criteria.
Participants were recruited based on physician referral from a tertiary medical center. The first participant was enrolled July 24, 2020, and last participant was enrolled June 28, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Galcanezumab | 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. Galcanezumab: Injection of study drug at 3 timepoints (day 30, day 60, day 90) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Galcanezumab | 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. Galcanezumab: Injection of study drug at 3 timepoints (day 30, day 60, day 90) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | score on a scale | Baseline (day 0), 45, 60, 75, 90, 105, 135, and 180 days |
|
|
180 days
Patient adverse events were collected from week 4 week observation period to Day 180+/-3 days. Patients were systematically asked via patient diary and regular investigator assessments. Investigator assessments were administered at week 4 of observation period, day 30, day 45, phone call #1 between days 45 and 60, day 60, day 75, phone call #2 via days 75 and 90, day 105, day 135, and day 180. In addition, patient was able contact investigator or research coordinator in between assessments.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label Galcanezumab | 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. Galcanezumab: Injection of study drug at 3 timepoints (day 30, day 60, day 90) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | CTCAE | Systematic Assessment | Unrelated |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sweta Sengupta, MD | Duke University | 919-668-2879 | sweta.sengupta@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2022 | Dec 16, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| D020435 | Glossopharyngeal Nerve Diseases |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| C000628360 | galcanezumab |
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Blood testing for presence of cytokine/chemokine pain or inflammation markers in patients' serum
| Baseline, Day 180 |
Genomic DNA testing |
| Day 0 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants With a Change in Use of Anti-pain Medication | Patient reported; any use of anti-pain medication. | Data not collected on two participants who withdrew from the study. Two participants stopped one medication and started another. | Posted | Count of Participants | Participants | Baseline through Day 135 |
|
|
|
| Primary | 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). | Posted | Number | adverse events | Collected through Day 180 |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | pg/mL | Baseline, Day 180 |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | pg/mL | Baseline, Day 180 |
|
|
|
| Other Pre-specified | Change in Circadian Rhythm Impairment | Based on data from Wearable Sleep Monitor | Not Posted | Daily, from Baseline through Day 180 | Participants |
| Other Pre-specified | Presence or Absence of DNA Polymorphisms That Predispose Treated Patients to Accentuated Responses of Either Lack of Response or Particularly Potent Response | Genomic DNA testing | Not Posted | Day 0 | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 13 |
| 20 |
| Urinary tract infection | Renal and urinary disorders | CTCAE | Systematic Assessment | Unrelated |
|
| Pain | Nervous system disorders | CTCAE | Systematic Assessment | Unrelated- had an attack of face pain and migraine headache |
|
| Dental caries | Infections and infestations | CTCAE | Systematic Assessment | Unrelated |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE | Systematic Assessment | Unrelated |
|
| Numbness | Nervous system disorders | CTCAE | Systematic Assessment | Unrelated- one pt with tip of thumb tingling and another with tingling and numbness of hands(related to existing small fiber neuropathy) |
|
| Hypothyroidism | Endocrine disorders | CTCAE | Systematic Assessment | Unrelated |
|
| Insomnia | General disorders | CTCAE | Systematic Assessment | Related |
|
| Constipation | Gastrointestinal disorders | CTCAE | Systematic Assessment | Related |
|
| Vertigo | Ear and labyrinth disorders | CTCAE | Systematic Assessment | Unrelated |
|
| Fatigue | General disorders | CTCAE | Systematic Assessment | Unrelated |
|
| Fainting | Cardiac disorders | CTCAE | Systematic Assessment | Unrelated |
|
| Fall | General disorders | CTCAE | Systematic Assessment | Unrelated |
|
| Back pain | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment | Unrelated-back injury causing back pain |
|
| Hypokalemia | General disorders | CTCAE | Systematic Assessment | Unrelated |
|
| Loss of awareness | Nervous system disorders | CTCAE | Systematic Assessment | Unrelated |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE | Systematic Assessment | Unrelated |
|
| Dehydration | General disorders | CTCAE | Systematic Assessment | Unrelated |
|
| Elevated creatinine | Renal and urinary disorders | CTCAE | Systematic Assessment | Unrelated |
|
| Weight gain | General disorders | CTCAE | Systematic Assessment | Unrelated |
|
| Covid-19 infection | Infections and infestations | CTCAE | Systematic Assessment | Unrelated |
|
| Injection site reaction | Skin and subcutaneous tissue disorders | CTCAE | Systematic Assessment | Related |
|
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| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| 4 = life threatening |
|
| 5 = death |
|