Investigational Use of Erenumab for the Treatment of Fibromyalgia Pain

NCT06411067 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: NMCP.2020.0010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Chronic pain; CGRP

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• CAGE-AID Questionnaire

  t=0, t=1 month, t=2 months, and t=3 months

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Drug: Saline

Erenumab

EXPERIMENTAL

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

Drug: Erenumab

Interventions

Erenumab DRUG

Monthly injection of erenumab for fibromyalgia

Erenumab

Saline DRUG

Monthly injection of 0.9% saline for control

Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth: lead

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

erenumab; Sodium Chloride

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Medication is drawn in unlabeled syringes by nurse. Investigators and outcomes assessors are blinded to treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, double blinded, placebo controlled study.

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: May 13, 2024
• Study Start: February 26, 2020
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)