Investigational Use of Erenumab for the Treatment of Fibromyalgia Pain

NCT ID: NCT06411067

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-26
• Study Completion Date: 2022-05-09

Brief Summary

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.

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control

1ml 0.9% of saline once a month in addition to the standard of care practiced at NMCP.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Monthly injection of 0.9% saline for control

Erenumab

140mg (1 ml) of Erenumab injected once a month in addition to the standard of care practiced at NMCP.

Group Type: EXPERIMENTAL

Erenumab

Intervention Type: DRUG

Monthly injection of erenumab for fibromyalgia

Interventions

Erenumab

Monthly injection of erenumab for fibromyalgia

Intervention Type: DRUG

Saline

Monthly injection of 0.9% saline for control

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Naval Medical Center, Portsmouth

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Countries

United States

Other Identifiers

NMCP.2020.0010

Identifier Type: -

Identifier Source: org_study_id