Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT06411067
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.
Study:
NCT06411067
Study Brief:
Protocol Section:
NCT06411067