Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411067
Status:
TERMINATED
Last Update Posted:
2024-05-13
First Post:
2020-03-06
Brief Title:
Investigational Use of Erenumab for the Treatment of Fibromyalgia Pain
Sponsor:
United States Naval Medical Center Portsmouth
Organization:
United States Naval Medical Center Portsmouth
Study Overview
Official Title:
Investigational Use of Erenumab for the Treatment of Fibromyalgia Pain
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lapse in IRB approval
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 t0 t1 month and t2 months with repeat assessment of symptoms with the Fibromyalgia score DVPRS BDI FIQ at t0 t1 month t 2 months and t3 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 09 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 09 saline Subcutaneously once monthly All patients will be monitored for one hour after the injection is administered
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 09 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 09 saline Subcutaneously once monthly All patients will be monitored for one hour after the injection is administered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None