Trial Outcomes & Findings for Anti-CGRP for Inflammation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia (NCT NCT04158752)

NCT ID: NCT04158752

Last Updated: 2026-02-02

Results Overview

Patient reported 0-10 analog pain scale, where 0 = no pain and 10 = worst pain imaginable. Reported as the change between timepoints.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 26 participants
• Primary outcome timeframe: Baseline (day 0), 45, 60, 75, 90, 105, 135, and 180 days
• Results posted on: 2026-02-02

Participant Flow

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.

Of the 26 enrolled, 20 patients met inclusion criteria.

Participant milestones

Measure	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)
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2
Overall Study STARTED	20

Reasons for withdrawal

Measure	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)
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Open Label Galcanezumab n=20 Participants 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)
Age, Continuous	54.4 years STANDARD_DEVIATION 12.94 • n=13 Participants
Sex: Female, Male Female	18 Participants n=13 Participants
Sex: Female, Male Male	2 Participants n=13 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=13 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=13 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants
Race (NIH/OMB) Asian	0 Participants n=13 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants
Race (NIH/OMB) Black or African American	1 Participants n=13 Participants
Race (NIH/OMB) White	19 Participants n=13 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants
Region of Enrollment United States	20 Participants n=13 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Open Label Galcanezumab n=20 Participants 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)
Change in Pain Score Change from 45 days to 180 days	-0.4566 score on a scale Standard Error 0.3887
Change in Pain Score Change from 75 days to 135 days	0.1949 score on a scale Standard Error 0.2876
Change in Pain Score Change from 75 days to 180 days	-0.07391 score on a scale Standard Error 0.3999
Change in Pain Score Change from 105 days to 180 days	-0.2689 score on a scale Standard Error 0.3922
Change in Pain Score Change from baseline to 60 days	-0.6224 score on a scale Standard Error 0.2663
Change in Pain Score Change from baseline to 90 days	-1.005 score on a scale Standard Error 0.2759
Change in Pain Score Change from baseline to 135 days	-0.8102 score on a scale Standard Error 0.2576
Change in Pain Score Change from baseline to 180 days	-1.079 score on a scale Standard Error 0.3816
Change in Pain Score Change from 45 days to 90 days	-0.3827 score on a scale Standard Error 0.2995
Change in Pain Score Change from 45 days to 135 days	-0.1877 score on a scale Standard Error 0.2796

PRIMARY outcome

Timeframe: Baseline through Day 135

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

Patient reported; any use of anti-pain medication.

Outcome measures

Measure	Open Label Galcanezumab n=18 Participants 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)
Number of Participants With a Change in Use of Anti-pain Medication Added one or more anti-pain medication	3 Participants
Number of Participants With a Change in Use of Anti-pain Medication Stopped one or more anti-pain medication	4 Participants
Number of Participants With a Change in Use of Anti-pain Medication No change	13 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Open Label Galcanezumab n=20 Participants 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)
Total Number of Adverse Events by Severity 5 = death	0 adverse events
Total Number of Adverse Events by Severity 1 = mild	29 adverse events
Total Number of Adverse Events by Severity 2 = moderate	5 adverse events
Total Number of Adverse Events by Severity 3 = severe	0 adverse events
Total Number of Adverse Events by Severity 4 = life threatening	0 adverse events

SECONDARY outcome

Timeframe: Baseline, Day 180

Blood testing for presence of cytokine/chemokine pain or inflammation markers in patients' serum

Outcome measures

Measure	Open Label Galcanezumab n=20 Participants 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)
Change in Level of TNF-alpha as a Marker of Pain or Inflammation	0.2 pg/mL Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline, Day 180

Blood testing for presence of cytokine/chemokine pain or inflammation markers in patients' serum

Outcome measures

Measure	Open Label Galcanezumab n=20 Participants 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)
Change in Level of IL-6 as a Marker of Pain or Inflammation	3.3 pg/mL Standard Deviation 4.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Daily, from Baseline through Day 180

Based on data from Wearable Sleep Monitor

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Genomic DNA testing

Outcome measures

Outcome data not reported

Adverse Events

Open Label Galcanezumab

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Open Label Galcanezumab n=20 participants at risk 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)
Injury, poisoning and procedural complications Back pain	5.0% 1/20 • 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.
Ear and labyrinth disorders Vertigo	5.0% 1/20 • 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.
General disorders Fatigue	5.0% 1/20 • 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.
Cardiac disorders Fainting	5.0% 1/20 • 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.
General disorders Fall	10.0% 2/20 • 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.
Gastrointestinal disorders Vomiting	5.0% 1/20 • 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.
Renal and urinary disorders Urinary tract infection	20.0% 4/20 • 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.
Nervous system disorders Pain	5.0% 1/20 • 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.
Infections and infestations Dental caries	10.0% 2/20 • 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.
Gastrointestinal disorders Abdominal pain	5.0% 1/20 • 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.
Nervous system disorders Numbness	10.0% 2/20 • 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.
Endocrine disorders Hypothyroidism	5.0% 1/20 • 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.
General disorders Insomnia	5.0% 1/20 • 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.
Gastrointestinal disorders Constipation	5.0% 1/20 • 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.
General disorders Hypokalemia	5.0% 1/20 • 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.
Nervous system disorders Loss of awareness	5.0% 1/20 • 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.
Injury, poisoning and procedural complications Fracture	5.0% 1/20 • 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.
General disorders Dehydration	5.0% 1/20 • 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.
Renal and urinary disorders Elevated creatinine	5.0% 1/20 • 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.
General disorders Weight gain	5.0% 1/20 • 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.
Infections and infestations Covid-19 infection	5.0% 1/20 • 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.
Skin and subcutaneous tissue disorders Injection site reaction	5.0% 1/20 • 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.

Additional Information

Sweta Sengupta, MD

Duke University

Phone: 919-668-2879

Email: sweta.sengupta@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place