Investigational Use of Erenumab for the Treatment of Fibromyalgia Pain

The purpose of this study is to determine if the administration of the CGRP-receptor antagonist erenumab is effective in decreasing pain and improving quality of life in patients with FMS by comparing the difference in pain scores in Fibromyalgia Impact Questionnaire, defense and veterans Pain Rating Scale and The American College of Rheumatology 2010 Preliminary Diagnostic Criteria for Fibromyalgia score over the study period.

Study Overview

• Status: Terminated
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Saline; Drug: Erenumab

Detailed Description

Patients will be identified as possible participants who are referred to the Pain Management Clinic who were previously diagnosed with Fibromyalgia. At the patients' first clinic visit, explanation of the study and informed written consent will be obtained. Once consent is obtained patients will be considered enrolled in the study and will be randomized to either the experimental (erenumab) or control (saline) groups. We will plan to enroll 70 patients, 35 in each arm. Patients will undergo baseline evaluation with The American College of Rheumatology 2010 Preliminary Diagnostic Criteria for Fibromyalgia score, Defense and Veterans Pain Rating Scale (DVPRS), Fibromyalgia Impact Questionnaire, Beck Depression Inventory and CAGE-AID questionnaire. Both groups will undergo injections at t=0, t=1 month, and t=2 months, with repeat assessment of symptoms with the Fibromyalgia score, DVPRS, BDI, FIQ, at t=0, t=1 month, t= 2 months, and t=3 months.

Enrolled patients must meet the following criteria: 1) must be between the ages of 18-85; 2) a diagnosis must be made from a practicing physician; 3) existing pain for more than 3 months; 4) pain resistant to common analgesics or intolerance to common analgesic; 5) widespread pain in at least 7 of 19 areas ( as reported by the patient); 6) symptom severity scale score over five including symptoms of fatigue, awaking unrefreshed and brain fog. Exclusion criteria involve 1) positive pregnancy test, 2) drug or alcohol abuse; 3) severe depression; 4) change in CNS active medications in the previous 2 months.

Patients in both groups will undergo injections with either erenumab or saline in the clinic performed by a clinic nurse. Once enrolled, patients will be randomized by a random number generator and enrolled into either the saline or erenumab group. Because erenumab is sold as an autoinjector, the injector will be inserted into a sterile vial, and the 1mL of erenumab will be withdrawn with a tuberculin needle and then injected subcuteanously. The saline group will be injected 1mL of 0.9% saline subcutaneously. The nurse administering the injection will not be blinded, however the investigators and the subjects will be blinded to achieve double blinding. The erenumab group will be administered 140mg Subcutaneously once monthly, while the control group will be administered 1ml 0.9% saline Subcutaneously once monthly. All patients will be monitored for one hour, after the injection is administered.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Portsmouth, Virginia, United States, 23708
      • Naval Medical Center Portsmouth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

diagnosis of fibromyalgia made by a practicing physician between the ages of 18-85 existing pain for more than 3 months pain resistant to common analgesics or intolerance to common analgesics Active Duty service members widespread pain in at least 7 of 19 areas; as reported by the patient symptom severity scale score over five including symptoms of fatigue, awaking unrefreshed and brain fog

Exclusion Criteria:

Pregnancy ages under 18 and over 85 years of age Non Active Duty service members Anaphylactic reactions Allergy to latex Drug or alcohol abuse severe depression change in CNS active medications in the preceding 2 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; 1ml 0.9% of saline once a month in addition to the standard of care practiced at NMCP.	Drug: Saline; Monthly injection of 0.9% saline for control
Experimental: Erenumab; 140mg (1 ml) of Erenumab injected once a month in addition to the standard of care practiced at NMCP.	Drug: Erenumab; Monthly injection of erenumab for fibromyalgia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defense and Veterans Pain Rating Scale (DVPRS)	Defense and Veterans Pain Rating Scale (DVPRS)	t=0, t=1 month, t=2 months, and t=3 months
Fibromyalgia Impact Questionnaire	Fibromyalgia Impact Questionnaire	t=0, t=1 month, t=2 months, and t=3 months
Beck Depression Inventory	Beck Depression Inventory	t=0, t=1 month, t=2 months, and t=3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAGE-AID Questionnaire	CAGE-AID Questionnaire	t=0, t=1 month, t=2 months, and t=3 months

Collaborators and Investigators

• Sponsor: United States Naval Medical Center, Portsmouth

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Actual): May 9, 2022
• Study Completion (Actual): May 9, 2022

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Chronic pain; Fibromyalgia; CGRP
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Calcitonin Gene-Related Peptide Receptor Antagonists; Erenumab
• Other Study ID Numbers: NMCP.2020.0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No