Ignite Creation Date:
2024-05-06 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05162027
Status:
TERMINATED
Last Update Posted:
2024-04-02
First Post:
2021-10-29
Brief Title:
Erenumab-aooe for Temporomandibular Disorders Management TMD Cgrp Antibody RElief TMD CARE
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Erenumab as a Therapeutic Approach for the Management of Painful Chronic Temporomandibular Disorders TMD
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TMD CARE
Brief Summary:
Evaluate erenumab- aooe efficacy as a therapeutic approach for the management of painful chronic temporomandibular disorders TMD
The study will be a randomized double blind placebo-controlled trial comparing erenumab-aooe vs Placebo
A total of 60 patients 30 per each arm aged 18-65 years old of either sex and any race or ethnicity presenting chronic temporomandibular disorders TMD meeting the Diagnostic Criteria for Temporomandibular Disorders DCTMD for Clinical and Research Applications of chronic TMD myalgia - arthralgia will be randomly assigned in a 11 parallel double-blind clinical trial to receive either erenumab-aooe or placebo Participants will attend 6 clinic visits Visit 0-Visit 5 over a period of 21 weeks 20 - 1 weeks Changes in pain intensity and other pain outcomes related to TMD will be assessed Blood samples will be collected and participants will need to keep a daily symptom diary and answer some other questionnaires
The study will be a randomized double blind placebo-controlled trial comparing erenumab-aooe vs Placebo
A total of 60 patients 30 per each arm aged 18-65 years old of either sex and any race or ethnicity presenting chronic temporomandibular disorders TMD meeting the Diagnostic Criteria for Temporomandibular Disorders DCTMD for Clinical and Research Applications of chronic TMD myalgia - arthralgia will be randomly assigned in a 11 parallel double-blind clinical trial to receive either erenumab-aooe or placebo Participants will attend 6 clinic visits Visit 0-Visit 5 over a period of 21 weeks 20 - 1 weeks Changes in pain intensity and other pain outcomes related to TMD will be assessed Blood samples will be collected and participants will need to keep a daily symptom diary and answer some other questionnaires
Detailed Description:
Chronic TMD is a considerable burden and affects significantly the quality of life of the sufferer For some patients TMD has a tendency to remit or improve pain symptomatology over time but for others TMD have the potential to become chronic and to lead to persistent dysfunction
Different classes of medications from anti-inflammatories muscle relaxants anxiolytics antidepressants anticonvulsants and a β-blocker have indicated to be beneficial for some patients as well as in clinical studies but tolerability and side effects may be present for some patients Furthermore the indications of these drugs are for other disorders so it is unclear their mechanism of action in TMD pathophysiology Currently there is no medication specifically indicated for the management of TMD based on its molecular pathophysiology However there is evidence showing that CGRP has a role in TMD pathophysiology CGRP is a key molecule in migraine pathophysiology Erenumab-aooe is the first antibody therapeutic targeting the CGRP and has shown efficacy to be well tolerated and with a safety profile similar to placebo for the prevention of migraine The scientific premise for this study is that inhibiting CGRP in chronic TMD will decrease pain pain related outcomes and improve TMJ biomechanics function in a safe and well tolerated manner for this patient population
Potential participants will be pre-screened at the Brotman Facial Pain clinic and the Oral and Maxillofacial Surgery Clinic both at the University of Maryland School of Dentistry or by telephone those willing to participate will be scheduled for a screening and baseline visit Visit 0 During this visit potential participants will be evaluated for eligibility meeting the Diagnostic Criteria for Temporomandibular Disorders DCTMD for Clinical and Research Applications of chronic TMD myalgia - arthralgia and written informed consent will be obtained
The screening and baseline procedures include medical history review clinical examinations tests and administration of questionnaires After screening eligible participants will start Visit 0Day 0 which is the start of the baseline period with a duration of 28 days4 weeks Instructions will be given for the completion of a Daily Symptom Diary DSD and other questionnaires at home or online Participants who show 80 compliance with the DSD and who meet the pain score inclusion criteria during the baseline period will be randomly assigned to one of two groups either the investigational drug or placebo and will be scheduled for Visit 1 Visit 1 can occur within 7 days1 week after the baseline period - 7 days
The study drug is erenumab-aooe 70mg SC injection Participants will attend 6 clinic visits Visit 0-Visit 5 over a period of 21 weeks 20 - 1 weeks or 140 - 7 days After randomization and on Visit 1 Week 4Day 28 the participant will receive the drug or placebo This same treatment will be administered once a month for 3 months 3 cycles12 weeks It will be administered on Visit 1Day 28Week 4 Visit 2Day 56Week 8 and Visit 3Day 84week 12 On Visit 0 baseline and on Visit 1 Visit 2 Visit 3 Visit 4Day 112Week 16 and visit 5Day 140Week 20 visits will include review of compliance with inclusion criteria medical history review review and collection of any adverse event clinical examinations questionnaires tests blood sample collection on BaselineVisit 0 and Visit 4 and instruction to complete the DSD and questionnaires
Different classes of medications from anti-inflammatories muscle relaxants anxiolytics antidepressants anticonvulsants and a β-blocker have indicated to be beneficial for some patients as well as in clinical studies but tolerability and side effects may be present for some patients Furthermore the indications of these drugs are for other disorders so it is unclear their mechanism of action in TMD pathophysiology Currently there is no medication specifically indicated for the management of TMD based on its molecular pathophysiology However there is evidence showing that CGRP has a role in TMD pathophysiology CGRP is a key molecule in migraine pathophysiology Erenumab-aooe is the first antibody therapeutic targeting the CGRP and has shown efficacy to be well tolerated and with a safety profile similar to placebo for the prevention of migraine The scientific premise for this study is that inhibiting CGRP in chronic TMD will decrease pain pain related outcomes and improve TMJ biomechanics function in a safe and well tolerated manner for this patient population
Potential participants will be pre-screened at the Brotman Facial Pain clinic and the Oral and Maxillofacial Surgery Clinic both at the University of Maryland School of Dentistry or by telephone those willing to participate will be scheduled for a screening and baseline visit Visit 0 During this visit potential participants will be evaluated for eligibility meeting the Diagnostic Criteria for Temporomandibular Disorders DCTMD for Clinical and Research Applications of chronic TMD myalgia - arthralgia and written informed consent will be obtained
The screening and baseline procedures include medical history review clinical examinations tests and administration of questionnaires After screening eligible participants will start Visit 0Day 0 which is the start of the baseline period with a duration of 28 days4 weeks Instructions will be given for the completion of a Daily Symptom Diary DSD and other questionnaires at home or online Participants who show 80 compliance with the DSD and who meet the pain score inclusion criteria during the baseline period will be randomly assigned to one of two groups either the investigational drug or placebo and will be scheduled for Visit 1 Visit 1 can occur within 7 days1 week after the baseline period - 7 days
The study drug is erenumab-aooe 70mg SC injection Participants will attend 6 clinic visits Visit 0-Visit 5 over a period of 21 weeks 20 - 1 weeks or 140 - 7 days After randomization and on Visit 1 Week 4Day 28 the participant will receive the drug or placebo This same treatment will be administered once a month for 3 months 3 cycles12 weeks It will be administered on Visit 1Day 28Week 4 Visit 2Day 56Week 8 and Visit 3Day 84week 12 On Visit 0 baseline and on Visit 1 Visit 2 Visit 3 Visit 4Day 112Week 16 and visit 5Day 140Week 20 visits will include review of compliance with inclusion criteria medical history review review and collection of any adverse event clinical examinations questionnaires tests blood sample collection on BaselineVisit 0 and Visit 4 and instruction to complete the DSD and questionnaires
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