Investigational Use of Erenumab for the Treatment of Fibromyalgia Pain

Fibromyalgia Clinical Trial

Official title:

Investigational Use of Erenumab for the Treatment of Fibromyalgia Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06411067
• Other study ID #: NMCP.2020.0010
• Status: Terminated
• Phase: Phase 3
• Start date: February 26, 2020
• Est. completion date: May 9, 2022

Study information

• Verified date: May 2024
• Source: United States Naval Medical Center, Portsmouth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Erenumab
Monthly injection of erenumab for fibromyalgia
• Saline
Monthly injection of 0.9% saline for control

Locations

Country	Name	City	State
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, Portsmouth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Fibromyalgia Impact Questionnaire	Fibromyalgia Impact Questionnaire	t=0, t=1 month, t=2 months, and t=3 months
Primary	Beck Depression Inventory	Beck Depression Inventory	t=0, t=1 month, t=2 months, and t=3 months
Secondary	CAGE-AID Questionnaire	CAGE-AID Questionnaire	t=0, t=1 month, t=2 months, and t=3 months