Erenumab-aooe for the Management of Trigeminal Neuropathic Pain.
NCT ID: NCT05142228
Last Updated: 2024-03-22
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
TERMINATED
Clinical Phase
PHASE2
Total Enrollment
5 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-05-31
Study Completion Date
2022-10-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study is a single center, placebo-controlled, double blind, randomized, phase II pilot to evaluate the efficacy of erenumab-aooe in the management of trigeminal neuropathic pain comparing erenumab-aooe vs Placebo.
A total of 40 patients (20 each arm) aged 18-65 years old of either sex, and any race or ethnicity, presenting trigeminal neuropathic pain will be randomly assigned in a 1:1 parallel, double-blind clinical trial, to receive either Erenumab or placebo. Participants will attend 6 clinic visits (Visit 0-Visit 5) over a period of 21 weeks. Changes in pain intensity and other pain related outcomes of trigeminal neuropathic pain will be assessed. Blood samples will be collected, and participants will need to keep a daily symptom diary and answer some other questionnaires.
A total of 40 patients (20 each arm) aged 18-65 years old of either sex, and any race or ethnicity, presenting trigeminal neuropathic pain will be randomly assigned in a 1:1 parallel, double-blind clinical trial, to receive either Erenumab or placebo. Participants will attend 6 clinic visits (Visit 0-Visit 5) over a period of 21 weeks. Changes in pain intensity and other pain related outcomes of trigeminal neuropathic pain will be assessed. Blood samples will be collected, and participants will need to keep a daily symptom diary and answer some other questionnaires.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder
NCT04884763
Temporomandibular Disorder
COMPLETED
PHASE2
802NP301 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia
NCT03070132
Trigeminal Neuralgia
WITHDRAWN
PHASE3
802NP302 Efficacy and Safety Study of BIIB074 in Participants With Trigeminal Neuralgia
NCT03637387
Trigeminal Neuralgia
WITHDRAWN
PHASE3
Efficacy and Safety of ATNC05 in Treatment of Atypical Facial Pain
NCT01920087
Atypical Facial Pain
Persistent Idiopathic Facial Pain
Atypical Trigeminal Neuralgia
+2 more
WITHDRAWN
PHASE2/PHASE3
An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of Trigeminal Neuralgia
NCT02801630
Trigeminal Neuralgia
UNKNOWN
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
TNP are a considerable burden and affects significantly the quality of life of the sufferer. There are medications for their management but while they may work for some patients, may not work for the others; in addition, side effects may be present for some patients with the need to decrease dosage to not optimal levels. Furthermore, the indications of these drugs are for other neuropathic pain disorders and currently there is no medication specifically indicated for the management of TNP based on its molecular pathophysiology.
The calcitonin gene-related peptide (CGRP) is a key neuropeptide involved in migraine pathophysiology. There is evidence showing that CGRP has a role in other disorders mediated by the trigeminal system in addition to migraine; CGRP has shown to have a role in orofacial pain such as in TMD and in trigeminal neuropathic pain. Erenumab-aooe is the first antibody therapeutic targeting the CGRP receptor with FDA approval for migraine prevention that is well tolerated and with a good safety profile. Therefore, the scientific premise for this study is that inhibiting the CGRP pathway in trigeminal neuropathic pain will decrease pain and pain related outcomes in a safe and well tolerated manner for this patient population.
Potential participants will be pre-screened at the Brotman Facial Pain clinic, at the Oral and Maxillofacial Surgery Clinic both at the University of Maryland, School of Dentistry, at the Pain Medicine Clinic at the University of Maryland, School of Medicine 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 for trigeminal neuropathic pain (subjects with diagnosis based on the International classification of headache disorders ICHD-3 and International classification of Orofacial Pains ICOP of idiopathic trigeminal neuralgia with concomitant continuous pain, painful posttraumatic trigeminal neuropathy or idiopathic painful trigeminal neuropathy) and written informed consent will be obtained. The screening and baseline procedures include medical history review, clinical examinations, tests and administration of questionnaires. Instructions will be given for the completion of a Daily Symptom Diary (DSD) and other questionnaires at home or online. Participants who show compliance with 80 % completion of the DSD and who meet the pain score (inclusion criteria) for 4 weeks/28 days during the baseline period from Visit 0, will be randomly assigned to one of two groups either the investigational drug or placebo and will be scheduled for Visit 1.
The study drug is Erenumab 140 mg, SC injection. Participants will attend 6 clinic visits (Visit 0-Visit 5). After randomization and on Visit 1, the participant will receive the drug or placebo. This same treatment will be administered once a month for 3 months (3 cycles/12weeks).
The calcitonin gene-related peptide (CGRP) is a key neuropeptide involved in migraine pathophysiology. There is evidence showing that CGRP has a role in other disorders mediated by the trigeminal system in addition to migraine; CGRP has shown to have a role in orofacial pain such as in TMD and in trigeminal neuropathic pain. Erenumab-aooe is the first antibody therapeutic targeting the CGRP receptor with FDA approval for migraine prevention that is well tolerated and with a good safety profile. Therefore, the scientific premise for this study is that inhibiting the CGRP pathway in trigeminal neuropathic pain will decrease pain and pain related outcomes in a safe and well tolerated manner for this patient population.
Potential participants will be pre-screened at the Brotman Facial Pain clinic, at the Oral and Maxillofacial Surgery Clinic both at the University of Maryland, School of Dentistry, at the Pain Medicine Clinic at the University of Maryland, School of Medicine 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 for trigeminal neuropathic pain (subjects with diagnosis based on the International classification of headache disorders ICHD-3 and International classification of Orofacial Pains ICOP of idiopathic trigeminal neuralgia with concomitant continuous pain, painful posttraumatic trigeminal neuropathy or idiopathic painful trigeminal neuropathy) and written informed consent will be obtained. The screening and baseline procedures include medical history review, clinical examinations, tests and administration of questionnaires. Instructions will be given for the completion of a Daily Symptom Diary (DSD) and other questionnaires at home or online. Participants who show compliance with 80 % completion of the DSD and who meet the pain score (inclusion criteria) for 4 weeks/28 days during the baseline period from Visit 0, will be randomly assigned to one of two groups either the investigational drug or placebo and will be scheduled for Visit 1.
The study drug is Erenumab 140 mg, SC injection. Participants will attend 6 clinic visits (Visit 0-Visit 5). After randomization and on Visit 1, the participant will receive the drug or placebo. This same treatment will be administered once a month for 3 months (3 cycles/12weeks).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Trigeminal Neuropathy
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Erenumab-aooe
Erenumab-aooe 140 mg/ml. Subcutaneous injection. Administered once every 4 weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.
Other Name: Aimovig®
Group Type
ACTIVE_COMPARATOR
Erenumab-Aooe
Intervention Type
DRUG
Administered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.
Placebo
Placebo. Subcutaneous injection.Administered once every 4 weeks/28 days at visit 1, visit 2 andvisit 3 for a total of 3 cycles.
Other name: Placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
OTHER
Administered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Erenumab-Aooe
Administered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.
Intervention Type
DRUG
Placebo
Administered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.
Intervention Type
OTHER
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Aimovig
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Provide signed and dated informed consent form
2. Is between 18 and 65 years of age (inclusive; male or female and any race or ethnicity)
3. Trigeminal neuropathic pain symptoms for a minimum of 3 months prior to randomization visit, localized in any trigeminal distribution (intraoral or extraoral).
4. Meets diagnostic criteria for Trigeminal neuropathic pain with diagnosis based on the International classification of headache disorders ICHD-3 and International classification of Orofacial Pains ICOP.
* Diagnosed with idiopathic trigeminal neuralgia with concomitant continuous pain per ICDH-3.
* Diagnosed with Painful posttraumatic trigeminal neuropathy or idiopathic painful trigeminal neuropathy per ICOP. May include:
* Subjects with a history of persistent pain of idiopathic origin or after dental extractions, mandibular fracture, surgical procedure, implant procedure and root canal therapy.
5. Participants must have a minimum mean of average daily pain intensity score of 4/10 in where 0= no pain and 10= maximum pain imaginable on a numerical rating scale (0-10), during the 4 weeks/28 days baseline period prior randomization.
6. If taking a prescription medication daily for the management of pain (taken for at least 30 days before baseline), agrees to continue the daily use of the medication throughout the study at the same dosage.
7. If taking prescription medication, opioid medication or OTC medications as needed or episodically for the management of pain agrees to discontinue its use prior to the Screening and Baseline Visit.
8. If taking OTC pain medications daily agrees to continue its daily use at the same dosage throughout the study.
• If a participant is taking an over-the-counter medication daily for management of other type of pain or for prophylaxis of myocardial infarction or stroke, the participant will be encouraged to continue the same usage of that medication throughout the study.
9. If subjects diagnosed with migraine, are allowed only if episodic, with attacks of duration up to 5 days/month and only using triptans or NSAIDs as an abortive medication.
10. Agrees to not start any new prescription medication for the management of trigeminal neuropathic pain or other type of pain throughout the study.
11. Agrees to not modify their prescription regimen for current trigeminal neuropathic pain or other types of pain throughout the study
12. Agrees not to receive any injection therapy for the management of neuropathic pain or migraine (e.g. nerve blocks, SPG blocks, steroid injections, Botox) during the course of the study
13. Agrees not to use any neuromodulatory device for the management of neuropathic pain or migraine during the course of the study
14. Agrees not to undergo any surgical procedure for the management of neuropathic pain during the course of the study
15. Agrees to not use cognitive behavioral therapy (CBT), biofeedback or acupuncture for the management of pain during the course of the study.
16. Females of childbearing potential agree to use one of the following methods of contraception throughout the study: licensed hormonal method, intrauterine device, female or male condoms with contraceptive foam, abstinence, bilateral tubal ligation/occlusion, or vasectomy in partner (if postmenopausal, must not have menstruated for at least 12 consecutive months)
17. Willing and able to understand and comply with all study procedures and be available for the duration of the study.
1. Provide signed and dated informed consent form
2. Is between 18 and 65 years of age (inclusive; male or female and any race or ethnicity)
3. Trigeminal neuropathic pain symptoms for a minimum of 3 months prior to randomization visit, localized in any trigeminal distribution (intraoral or extraoral).
4. Meets diagnostic criteria for Trigeminal neuropathic pain with diagnosis based on the International classification of headache disorders ICHD-3 and International classification of Orofacial Pains ICOP.
* Diagnosed with idiopathic trigeminal neuralgia with concomitant continuous pain per ICDH-3.
* Diagnosed with Painful posttraumatic trigeminal neuropathy or idiopathic painful trigeminal neuropathy per ICOP. May include:
* Subjects with a history of persistent pain of idiopathic origin or after dental extractions, mandibular fracture, surgical procedure, implant procedure and root canal therapy.
5. Participants must have a minimum mean of average daily pain intensity score of 4/10 in where 0= no pain and 10= maximum pain imaginable on a numerical rating scale (0-10), during the 4 weeks/28 days baseline period prior randomization.
6. If taking a prescription medication daily for the management of pain (taken for at least 30 days before baseline), agrees to continue the daily use of the medication throughout the study at the same dosage.
7. If taking prescription medication, opioid medication or OTC medications as needed or episodically for the management of pain agrees to discontinue its use prior to the Screening and Baseline Visit.
8. If taking OTC pain medications daily agrees to continue its daily use at the same dosage throughout the study.
• If a participant is taking an over-the-counter medication daily for management of other type of pain or for prophylaxis of myocardial infarction or stroke, the participant will be encouraged to continue the same usage of that medication throughout the study.
9. If subjects diagnosed with migraine, are allowed only if episodic, with attacks of duration up to 5 days/month and only using triptans or NSAIDs as an abortive medication.
10. Agrees to not start any new prescription medication for the management of trigeminal neuropathic pain or other type of pain throughout the study.
11. Agrees to not modify their prescription regimen for current trigeminal neuropathic pain or other types of pain throughout the study
12. Agrees not to receive any injection therapy for the management of neuropathic pain or migraine (e.g. nerve blocks, SPG blocks, steroid injections, Botox) during the course of the study
13. Agrees not to use any neuromodulatory device for the management of neuropathic pain or migraine during the course of the study
14. Agrees not to undergo any surgical procedure for the management of neuropathic pain during the course of the study
15. Agrees to not use cognitive behavioral therapy (CBT), biofeedback or acupuncture for the management of pain during the course of the study.
16. Females of childbearing potential agree to use one of the following methods of contraception throughout the study: licensed hormonal method, intrauterine device, female or male condoms with contraceptive foam, abstinence, bilateral tubal ligation/occlusion, or vasectomy in partner (if postmenopausal, must not have menstruated for at least 12 consecutive months)
17. Willing and able to understand and comply with all study procedures and be available for the duration of the study.
Exclusion Criteria
1. Participants with a history of congestive heart failure or uncontrolled diabetes.
2. Participants with serious hepatic, respiratory, hematologic or immunologic illnesses, an unstable cardiovascular disease, or any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or Erenumab or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the participant inappropriate for entry into this trial.
3. Participants with high blood pressure, uncontrolled high blood pressure, malignant disease, chronic constipation, any malabsorption disorders such as IBSc or any other severe acute or chronic medical or psychiatric condition (major depression, schizophrenia, dementia) or laboratory finding that may increase the risk associated with trial participation with Erenumab, that in the judgement of the investigators would interfere with study assessments and/or would make the participant inappropriate for entry into this trial.
4. Participants with active malignancy of any type or a history a malignancy (with exception of participants with malignancy surgically removed with no evidence of recurrence within 5 years before enrollment.
5. Participants with evidence or a history of drug or alcohol abuse within the past 12 months or has been diagnosed with a substance abuse disorder.
6. Participants with dental pain (determined pain of odontogenic/periodontal origin).
7. Participants with significant neurological disorders.
8. Patients with chronic migraine with and w/o aura following the ICHD-3 criteria treated or not treated with medication
• Without excluding headache attributed to TMD
9. Participants currently taking or have previously taken Erenumab or other CGRP monoclonal antibody (mAmb) or currently taking a CGRP-Receptor antagonist (gepants) for migraine prevention.
10. Patients with hypersensitivity to Erenumab
11. Participants with trigeminal neuropathic pain taken medications for the management of trigeminal neuropathic pain in where daily dosage has been modified within three weeks before baseline.
12. Neuroimaging showing the presence of neurovascular compression or AV malformation.
13. Neuroimaging showing the presence of intracranial pathology (i.e. multiple sclerosis, tumor).
14. Presence of extracranial pathology in the area of pain (tumor, lesion).
15. Has been treated with another investigational drug or treatment within 30 days prior to the Screening and Baseline Visit
16. Has commenced a new daily prescription medication for the management of pain within 30 days prior to the Screening and Baseline Visit
17. Currently taking opioid medication whether episodically or daily, within 30 days prior to the Screening and Baseline Visit.
18. Patients sensitive to Latex
19. If planning to become pregnant, pregnant or breastfeeding.
20. Anything that, in the opinion of the investigator, would place the participant at increased risk or impede the participant's full compliance with or completion of the study.
2. Participants with serious hepatic, respiratory, hematologic or immunologic illnesses, an unstable cardiovascular disease, or any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or Erenumab or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the participant inappropriate for entry into this trial.
3. Participants with high blood pressure, uncontrolled high blood pressure, malignant disease, chronic constipation, any malabsorption disorders such as IBSc or any other severe acute or chronic medical or psychiatric condition (major depression, schizophrenia, dementia) or laboratory finding that may increase the risk associated with trial participation with Erenumab, that in the judgement of the investigators would interfere with study assessments and/or would make the participant inappropriate for entry into this trial.
4. Participants with active malignancy of any type or a history a malignancy (with exception of participants with malignancy surgically removed with no evidence of recurrence within 5 years before enrollment.
5. Participants with evidence or a history of drug or alcohol abuse within the past 12 months or has been diagnosed with a substance abuse disorder.
6. Participants with dental pain (determined pain of odontogenic/periodontal origin).
7. Participants with significant neurological disorders.
8. Patients with chronic migraine with and w/o aura following the ICHD-3 criteria treated or not treated with medication
• Without excluding headache attributed to TMD
9. Participants currently taking or have previously taken Erenumab or other CGRP monoclonal antibody (mAmb) or currently taking a CGRP-Receptor antagonist (gepants) for migraine prevention.
10. Patients with hypersensitivity to Erenumab
11. Participants with trigeminal neuropathic pain taken medications for the management of trigeminal neuropathic pain in where daily dosage has been modified within three weeks before baseline.
12. Neuroimaging showing the presence of neurovascular compression or AV malformation.
13. Neuroimaging showing the presence of intracranial pathology (i.e. multiple sclerosis, tumor).
14. Presence of extracranial pathology in the area of pain (tumor, lesion).
15. Has been treated with another investigational drug or treatment within 30 days prior to the Screening and Baseline Visit
16. Has commenced a new daily prescription medication for the management of pain within 30 days prior to the Screening and Baseline Visit
17. Currently taking opioid medication whether episodically or daily, within 30 days prior to the Screening and Baseline Visit.
18. Patients sensitive to Latex
19. If planning to become pregnant, pregnant or breastfeeding.
20. Anything that, in the opinion of the investigator, would place the participant at increased risk or impede the participant's full compliance with or completion of the study.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Sponsor Role
collaborator
University of Maryland, Baltimore
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marcela Romero Reyes
Clinical Associate Professor, Director Brotman Facial Pain Clinic
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Maryland, School of Dentistry, Brotman Facial Pain Clinic
Baltimore, Maryland, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Mignogna MD, Fedele S. The neglected global burden of chronic oral diseases. J Dent Res. 2006 May;85(5):390-1. doi: 10.1177/154405910608500501. No abstract available.
Reference Type
BACKGROUND
Baad-Hansen L, Leijon G, Svensson P, List T. Comparison of clinical findings and psychosocial factors in patients with atypical odontalgia and temporomandibular disorders. J Orofac Pain. 2008 Winter;22(1):7-14.
Reference Type
BACKGROUND
Penarrocha MA, Penarrocha D, Bagan JV, Penarrocha M. Post-traumatic trigeminal neuropathy. A study of 63 cases. Med Oral Patol Oral Cir Bucal. 2012 Mar 1;17(2):e297-300. doi: 10.4317/medoral.17401.
Reference Type
BACKGROUND
Smith JG, Elias LA, Yilmaz Z, Barker S, Shah K, Shah S, Renton T. The psychosocial and affective burden of posttraumatic neuropathy following injuries to the trigeminal nerve. J Orofac Pain. 2013 Fall;27(4):293-303. doi: 10.11607/jop.1056.
Reference Type
BACKGROUND
Baad-Hansen L, Benoliel R. Neuropathic orofacial pain: Facts and fiction. Cephalalgia. 2017 Jun;37(7):670-679. doi: 10.1177/0333102417706310. Epub 2017 Apr 12.
Reference Type
BACKGROUND
Romero-Reyes M, Uyanik JM. Orofacial pain management: current perspectives. J Pain Res. 2014 Feb 21;7:99-115. doi: 10.2147/JPR.S37593. eCollection 2014.
Reference Type
BACKGROUND
International Classification of Orofacial Pain, 1st edition (ICOP). Cephalalgia. 2020 Feb;40(2):129-221. doi: 10.1177/0333102419893823. No abstract available.
Reference Type
BACKGROUND
Lewis MA, Sankar V, De Laat A, Benoliel R. Management of neuropathic orofacial pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Mar;103 Suppl:S32.e1-24. doi: 10.1016/j.tripleo.2006.10.014.
Reference Type
BACKGROUND
McQuay HJ, Tramer M, Nye BA, Carroll D, Wiffen PJ, Moore RA. A systematic review of antidepressants in neuropathic pain. Pain. 1996 Dec;68(2-3):217-27. doi: 10.1016/s0304-3959(96)03140-5.
Reference Type
BACKGROUND
McQuay H, Carroll D, Jadad AR, Wiffen P, Moore A. Anticonvulsant drugs for management of pain: a systematic review. BMJ. 1995 Oct 21;311(7012):1047-52. doi: 10.1136/bmj.311.7012.1047.
Reference Type
BACKGROUND
Dworkin RH, O'Connor AB, Audette J, Baron R, Gourlay GK, Haanpaa ML, Kent JL, Krane EJ, Lebel AA, Levy RM, Mackey SC, Mayer J, Miaskowski C, Raja SN, Rice AS, Schmader KE, Stacey B, Stanos S, Treede RD, Turk DC, Walco GA, Wells CD. Recommendations for the pharmacological management of neuropathic pain: an overview and literature update. Mayo Clin Proc. 2010 Mar;85(3 Suppl):S3-14. doi: 10.4065/mcp.2009.0649.
Reference Type
BACKGROUND
Zakrzewska JM. Medical management of trigeminal neuropathic pains. Expert Opin Pharmacother. 2010 Jun;11(8):1239-54. doi: 10.1517/14656561003767449.
Reference Type
BACKGROUND
Edvinsson L. The CGRP Pathway in Migraine as a Viable Target for Therapies. Headache. 2018 May;58 Suppl 1:33-47. doi: 10.1111/head.13305.
Reference Type
BACKGROUND
King CT, Gegg CV, Hu SN, Sen Lu H, Chan BM, Berry KA, Brankow DW, Boone TJ, Kezunovic N, Kelley MR, Shi L, Xu C. Discovery of the Migraine Prevention Therapeutic Aimovig (Erenumab), the First FDA-Approved Antibody against a G-Protein-Coupled Receptor. ACS Pharmacol Transl Sci. 2019 Sep 3;2(6):485-490. doi: 10.1021/acsptsci.9b00061. eCollection 2019 Dec 13.
Reference Type
BACKGROUND
Reuter U, Goadsby PJ, Lanteri-Minet M, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018 Nov 24;392(10161):2280-2287. doi: 10.1016/S0140-6736(18)32534-0. Epub 2018 Oct 22.
Reference Type
BACKGROUND
Ashina H, Iljazi A, Al-Khazali HM, Eigenbrodt AK, Larsen EL, Andersen AM, Hansen KJ, Brauner KB, Morch-Jessen T, Chaudhry B, Antic S, Christensen CE, Ashina M, Amin FM, Schytz HW. Efficacy, tolerability, and safety of erenumab for the preventive treatment of persistent post-traumatic headache attributed to mild traumatic brain injury: an open-label study. J Headache Pain. 2020 Jun 3;21(1):62. doi: 10.1186/s10194-020-01136-z.
Reference Type
BACKGROUND
Cady RJ, Glenn JR, Smith KM, Durham PL. Calcitonin gene-related peptide promotes cellular changes in trigeminal neurons and glia implicated in peripheral and central sensitization. Mol Pain. 2011 Dec 6;7:94. doi: 10.1186/1744-8069-7-94.
Reference Type
BACKGROUND
Romero-Reyes M, Pardi V, Akerman S. A potent and selective calcitonin gene-related peptide (CGRP) receptor antagonist, MK-8825, inhibits responses to nociceptive trigeminal activation: Role of CGRP in orofacial pain. Exp Neurol. 2015 Sep;271:95-103. doi: 10.1016/j.expneurol.2015.05.005. Epub 2015 May 14.
Reference Type
BACKGROUND
Akerman S, Romero-Reyes M. Preclinical studies investigating the neural mechanisms involved in the co-morbidity of migraine and temporomandibular disorders: the role of CGRP. Br J Pharmacol. 2020 Dec;177(24):5555-5568. doi: 10.1111/bph.15263. Epub 2020 Oct 21.
Reference Type
BACKGROUND
Sugawara S, Okada S, Katagiri A, Saito H, Suzuki T, Komiya H, Kanno K, Ohara K, Iinuma T, Toyofuku A, Iwata K. Interaction between calcitonin gene-related peptide-immunoreactive neurons and satellite cells via P2Y12 R in the trigeminal ganglion is involved in neuropathic tongue pain in rats. Eur J Oral Sci. 2017 Dec;125(6):444-452. doi: 10.1111/eos.12382. Epub 2017 Oct 11.
Reference Type
BACKGROUND
Michot B, Kayser V, Hamon M, Bourgoin S. CGRP receptor blockade by MK-8825 alleviates allodynia in infraorbital nerve-ligated rats. Eur J Pain. 2015 Feb;19(2):281-90. doi: 10.1002/ejp.616. Epub 2014 Nov 5.
Reference Type
BACKGROUND
Qin ZL, Yang LQ, Li N, Yue JN, Wu BS, Tang YZ, Guo YN, Lai GH, Ni JX. Clinical study of cerebrospinal fluid neuropeptides in patients with primary trigeminal neuralgia. Clin Neurol Neurosurg. 2016 Apr;143:111-5. doi: 10.1016/j.clineuro.2016.02.012. Epub 2016 Feb 10.
Reference Type
BACKGROUND
Farajzadeh A, Bathaie SZ, Arabkheradmand J, Ghodsi SM, Faghihzadeh S. Different Pain States of Trigeminal Neuralgia Make Significant Changes in the Plasma Proteome and Some Biochemical Parameters: a Preliminary Cohort Study. J Mol Neurosci. 2018 Dec;66(4):524-534. doi: 10.1007/s12031-018-1183-2. Epub 2018 Oct 17.
Reference Type
BACKGROUND
Zhang Y, Lian Y, Zhang H, Xie N, Chen Y. CGRP Plasma Levels Decrease in Classical Trigeminal Neuralgia Patients Treated with Botulinum Toxin Type A: A Pilot Study. Pain Med. 2020 Aug 1;21(8):1611-1615. doi: 10.1093/pm/pnaa028.
Reference Type
BACKGROUND
Tepper S, Ashina M, Reuter U, Brandes JL, Dolezil D, Silberstein S, Winner P, Leonardi D, Mikol D, Lenz R. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017 Jun;16(6):425-434. doi: 10.1016/S1474-4422(17)30083-2. Epub 2017 Apr 28.
Reference Type
BACKGROUND
Ashina M, Tepper S, Brandes JL, Reuter U, Boudreau G, Dolezil D, Cheng S, Zhang F, Lenz R, Klatt J, Mikol DD. Efficacy and safety of erenumab (AMG334) in chronic migraine patients with prior preventive treatment failure: A subgroup analysis of a randomized, double-blind, placebo-controlled study. Cephalalgia. 2018 Sep;38(10):1611-1621. doi: 10.1177/0333102418788347. Epub 2018 Jul 8.
Reference Type
BACKGROUND
Lattanzi S, Brigo F, Trinka E, Vernieri F, Corradetti T, Dobran M, Silvestrini M. Erenumab for Preventive Treatment of Migraine: A Systematic Review and Meta-Analysis of Efficacy and Safety. Drugs. 2019 Mar;79(4):417-431. doi: 10.1007/s40265-019-01069-1.
Reference Type
BACKGROUND
Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
Reference Type
BACKGROUND
Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
Reference Type
BACKGROUND
Symonds T, Randall JA, Hoffman DL, Zakrzewska JM, Gehringer W, Lee JY. Measuring the impact of trigeminal neuralgia pain: the Penn Facial Pain Scale-Revised. J Pain Res. 2018 Jun 5;11:1067-1073. doi: 10.2147/JPR.S152958. eCollection 2018.
Reference Type
BACKGROUND
Von Korff M, Ormel J, Keefe FJ, Dworkin SF. Grading the severity of chronic pain. Pain. 1992 Aug;50(2):133-149. doi: 10.1016/0304-3959(92)90154-4.
Reference Type
BACKGROUND
Perrot S, Lanteri-Minet M. Patients' Global Impression of Change in the management of peripheral neuropathic pain: Clinical relevance and correlations in daily practice. Eur J Pain. 2019 Jul;23(6):1117-1128. doi: 10.1002/ejp.1378. Epub 2019 Mar 18.
Reference Type
BACKGROUND
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Reference Type
BACKGROUND
Svensson P, Drangsholt M, Pfau DB, List T. Neurosensory testing of orofacial pain in the dental clinic. J Am Dent Assoc. 2012 Aug;143(8):e37-9. doi: 10.14219/jada.archive.2012.0301. No abstract available.
Reference Type
BACKGROUND
Kim HJ, Greenspan JD, Ohrbach R, Fillingim RB, Maixner W, Renn CL, Johantgen M, Zhu S, Dorsey SG. Racial/ethnic differences in experimental pain sensitivity and associated factors - Cardiovascular responsiveness and psychological status. PLoS One. 2019 Apr 18;14(4):e0215534. doi: 10.1371/journal.pone.0215534. eCollection 2019.
Reference Type
BACKGROUND
Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.
Reference Type
BACKGROUND
Nasri-Heir C, Khan J, Benoliel R, Feng C, Yarnitsky D, Kuo F, Hirschberg C, Hartwell G, Huang CY, Heir G, Korczeniewska O, Diehl SR, Eliav E. Altered pain modulation in patients with persistent postendodontic pain. Pain. 2015 Oct;156(10):2032-2041. doi: 10.1097/j.pain.0000000000000265.
Reference Type
BACKGROUND
Sarnthein J, Stern J, Aufenberg C, Rousson V, Jeanmonod D. Increased EEG power and slowed dominant frequency in patients with neurogenic pain. Brain. 2006 Jan;129(Pt 1):55-64. doi: 10.1093/brain/awh631. Epub 2005 Sep 23.
Reference Type
BACKGROUND
de Vries M, Wilder-Smith OH, Jongsma ML, van den Broeke EN, Arns M, van Goor H, van Rijn CM. Altered resting state EEG in chronic pancreatitis patients: toward a marker for chronic pain. J Pain Res. 2013 Nov 25;6:815-24. doi: 10.2147/JPR.S50919.
Reference Type
BACKGROUND
Seminowicz DA, Bilska K, Chowdhury NS, Skippen P, Millard SK, Chiang AKI, Chen S, Furman AJ, Schabrun SM. A novel cortical biomarker signature for predicting pain sensitivity: protocol for the PREDICT longitudinal analytical validation study. Pain Rep. 2020 Jul 27;5(4):e833. doi: 10.1097/PR9.0000000000000833. eCollection 2020 Jul-Aug.
Reference Type
BACKGROUND
Furman AJ, Thapa T, Summers SJ, Cavaleri R, Fogarty JS, Steiner GZ, Schabrun SM, Seminowicz DA. Cerebral peak alpha frequency reflects average pain severity in a human model of sustained, musculoskeletal pain. J Neurophysiol. 2019 Oct 1;122(4):1784-1793. doi: 10.1152/jn.00279.2019. Epub 2019 Aug 7.
Reference Type
BACKGROUND
Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
Reference Type
BACKGROUND
Bazanova OM, Vernon D. Interpreting EEG alpha activity. Neurosci Biobehav Rev. 2014 Jul;44:94-110. doi: 10.1016/j.neubiorev.2013.05.007. Epub 2013 May 20.
Reference Type
BACKGROUND
Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004 Jan;27(1):26-35. doi: 10.1016/j.jmpt.2003.11.003.
Reference Type
BACKGROUND
Gomez-Arguelles JM, Dorado R, Sepulveda JM, Herrera A, Arrojo FG, Aragon E, Huete CR, Terron C, Anciones B. Oxcarbazepine monotherapy in carbamazepine-unresponsive trigeminal neuralgia. J Clin Neurosci. 2008 May;15(5):516-9. doi: 10.1016/j.jocn.2007.04.010. Epub 2008 Apr 2.
Reference Type
BACKGROUND
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
Reference Type
BACKGROUND
Son H, Friedmann E, Thomas SA. Application of pattern mixture models to address missing data in longitudinal data analysis using SPSS. Nurs Res. 2012 May-Jun;61(3):195-203. doi: 10.1097/NNR.0b013e3182541d8c.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HP-00097072
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Phase IIa Withdrawal Study of CNV1014802 in Patients With Trigeminal Neuralgia
NCT01540630
COMPLETED
PHASE2
Efficacy, Safety, and Tolerability of SR750 in Patients With Trigeminal Neuralgia
NCT06571448
ACTIVE_NOT_RECRUITING
PHASE2
Study to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Peripheral Neuropathic Pain
NCT00976534
TERMINATED
PHASE2
Safety and Efficacy of AGN201781 in Neuropathic Pain
NCT00533351
TERMINATED
PHASE2
A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy
NCT01087203
TERMINATED
PHASE2
A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia
NCT01364259
TERMINATED
PHASE3
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..
NCT01200524
COMPLETED
PHASE2
A Study of Tanezumab in Adults With Chronic Low Back Pain
NCT00876187
COMPLETED
PHASE2
Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1
NCT00109772
TERMINATED
PHASE2
Characterization of the Temporo-masseteric Nerve Block (TMNB) in Healthy Subjects
NCT05507164
RECRUITING
PHASE2
A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1
NCT00166452
COMPLETED
PHASE3
RN624 For Pain Of Post-Herpetic Neuralgia
NCT00568321
COMPLETED
PHASE2
Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain
NCT01043263
COMPLETED
PHASE2
Ear Acupuncture for Neuropathic Pain
NCT05052645
WITHDRAWN
NA
Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia
NCT02088632
TERMINATED
PHASE2
A Phase 1b Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SR419
NCT04494815
COMPLETED
PHASE1/PHASE2
Dose-Tolerability Titration Study to Evaluate The Efficacy And Safety Of Perampanel (E2007) In Patients With Post-Herpetic Neuralgia (PHN)
NCT00592774
COMPLETED
PHASE2
Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Painful Lumbar Radiculopathy
NCT00120120
COMPLETED
PHASE2/PHASE3
Neurotropin to Treat Chronic Neuropathic Pain
NCT00006289
TERMINATED
PHASE2
Clinical Management of Neuropathic Pain With Ramelteon
NCT00753623
TERMINATED
NA
Study to Assess the Efficacy, Safety, and Tolerability of ADL5747 in Participants With Postherpetic Neuralgia
NCT01058642
TERMINATED
PHASE2
Effect of GSK1014802 on Electrical Hyperalgesia and Threshold Tracking in Healthy Subjects
NCT00964288
TERMINATED
PHASE1
The Study of GW493838, an Adenosine A1 Agonist, in Peripheral Neuropathic Pain
NCT00376454
COMPLETED
PHASE2