Erenumab-aooe for the Management of Trigeminal Neuropathic Pain.

NCT05142228 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HP-00097072
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trigeminal Neuropathy

Keywords

Trigeminal neuropathic pain; Trigeminal Nerve Injury; Idiopathic trigeminal neuralgia with continuous pain; Idiopathic painful trigeminal neuropathy; Trigeminal Nerve Diseases; Cranial Nerve Diseases; Calcitonin Gene-Related Peptide Receptor Antagonists; CGRP Receptor Antagonist; Erenumab; Neuralgia; Face Pain; Physiological effects of drugs; Trigeminal Nerve Trauma

Outcome Measures

Primary Outcomes (1)

• Change of >= 30% Reduction in the Monthly (28 Days) Average Pain Score From Baseline to Visit 4, Compared to Placebo.

  Assessment of the efficacy of erenumab-aooe in the proportion of participants that achieve \>=30% reduction (Yes/no) in monthly (28 days) average pain score from baseline to Visit 4 (the last monthly treatment cycle), compared to placebo. The daily pain intensity score will be measured on a 11-point (0-10) numeric rating scale (NPRS) and reported in the Daily Symptom Diary (DSD). The monthly mean pain intensity score will be determined from baseline (4 weeks/28 days), for each month during the 12 weeks of treatment.

  From Visit 0 (Baseline phase/Study day 0) to Visit 4 (Study day 112 +/- 7)

Secondary Outcomes (6)

• Efficacy of Erenumab-aooe Compared to Placebo on the Reduction in Monthly Average Daily Pain Score From Baseline to the End of 12-week Treatment Period.

  From Visit 0 (Baseline phase/Study day 0) to Visit 4 (study day 112 +/- 7)

• Change of >= 30% Reduction in the Monthly (28 Days) Average Pain Score Compared to Placebo From Baseline to Visit 5.

  From Visit 0 (Baseline phase/Study day 0) to Visit 5 ( study day 140 +/- 7)

• Change in Participant Ratings Compared to Placebo for Improving Physical Function and Health Related Quality of Life in Patients With Trigeminal Neuropathic Pain Measured by the Penn Facial Pain Scale-Revised.

  Visit 0 (baseline/study day 0), Visit 1 (study day 28), Visit 2 (study day 56), Visit 3 (study day 84), Visit 4 (study day 112) and Visit 5 (140) +/- 7

• Change in Graded Chronic Pain Scale (GCPS) Outcomes During Erenumab-aooe Treatment, After Treatment and Compared to Placebo.

  Visit 0 (baseline/study day 0), Visit 1 (study day 28), Visit 2 (study day 56), Visit 3 (study day 84), Visit 4 (study day 112) and Visit 5 (140) +/- 7

• Change in the Hospital Anxiety and Depression Scale (HADS). Anxiety and Depression Score Change During Erenumab-aooe Treatment, After Treatment and Compared to Placebo.

  Visit 0 (baseline/study day 0), Visit 1 (study day 28), Visit 2 (study day 56), Visit 3 (study day 84), Visit 4 (study day 112) and Visit 5 (140) +/- 7

Other Outcomes (3)

• Change of Pro-inflammatory and Anti-inflammatory Cytokine Profiles (Th1/Th2) When Compared to Placebo.

  Visit 0 (Baseline/study day 0) and Visit 4 (study day 112) +/- 7

• Change in Nociceptive Processing and Sensitization Determined With Quantitative Sensory Testing (QST) Measurements When Compared to Placebo.

  Visit 0 (Baseline/Study day 0) and Visit 4 (study day 112 +/- 7)

• Change in Pain Sensitivity Determined by Peak Alpha Frequency (PAF) Measurements During EEG (Electroencephalogram) Assessment When Compared to Placebo.

  Visit 0 (Baseline/Study day 0) and Visit 4 (study day 112 +/- 7)

Study Arms (2)

Erenumab-aooe

ACTIVE COMPARATOR

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®

Drug: Erenumab-Aooe

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Erenumab-Aooe DRUG

Administered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.

Also known as: Aimovig

Erenumab-aooe

Placebo OTHER

Administered once every 4weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles.

Placebo

Eligibility Criteria

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

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Provide signed and dated informed consent form
• Is between 18 and 65 years of age (inclusive; male or female and any race or ethnicity)
• Trigeminal neuropathic pain symptoms for a minimum of 3 months prior to randomization visit, localized in any trigeminal distribution (intraoral or extraoral).
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Agrees to not start any new prescription medication for the management of trigeminal neuropathic pain or other type of pain throughout the study.

You may not qualify if:

• Participants with a history of congestive heart failure or uncontrolled diabetes.
• 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.
• 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.
• 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.
• 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.
• Participants with dental pain (determined pain of odontogenic/periodontal origin).
• Participants with significant neurological disorders.
• 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
• 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.
• Patients with hypersensitivity to Erenumab
• 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.
• Neuroimaging showing the presence of neurovascular compression or AV malformation.
• Neuroimaging showing the presence of intracranial pathology (i.e. multiple sclerosis, tumor).
• Presence of extracranial pathology in the area of pain (tumor, lesion).

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Amgen: collaborator

Study Sites (1)

University of Maryland, School of Dentistry, Brotman Facial Pain Clinic

Baltimore, Maryland, 21201, United States

Location

Related Publications (47)

• 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.

  PMID: 16632750 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.

  PMID: 18351030 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.

  PMID: 22143689 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.

  PMID: 24171179 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.

  PMID: 28403646 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.

  PMID: 24591846 BACKGROUND

• International Classification of Orofacial Pain, 1st edition (ICOP). Cephalalgia. 2020 Feb;40(2):129-221. doi: 10.1177/0333102419893823. No abstract available.

  PMID: 32103673 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.

  PMID: 17379152 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.

  PMID: 9121808 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.

  PMID: 7580659 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.

  PMID: 20194146 BACKGROUND

• Zakrzewska JM. Medical management of trigeminal neuropathic pains. Expert Opin Pharmacother. 2010 Jun;11(8):1239-54. doi: 10.1517/14656561003767449.

  PMID: 20426709 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.

  PMID: 29697153 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.

  PMID: 32259079 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.

  PMID: 30360965 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.

  PMID: 32493206 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.

  PMID: 22145886 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.

  PMID: 25981890 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.

  PMID: 32929719 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.

  PMID: 29023985 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.

  PMID: 25370954 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.

  PMID: 26918582 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.

  PMID: 30334198 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.

  PMID: 32167549 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.

  PMID: 28460892 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.

  PMID: 29984601 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.

  PMID: 30793254 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.

  PMID: 15621359 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.

  PMID: 11690728 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.

  PMID: 29892203 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.

  PMID: 1408309 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.

  PMID: 30793414 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.

  PMID: 6880820 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.

  PMID: 22855909 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.

  PMID: 30998733 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.

  PMID: 16697110 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.

  PMID: 26098442 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.

  PMID: 16183660 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.

  PMID: 24379694 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.

  PMID: 32766469 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.

  PMID: 31389754 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.

  PMID: 29368949 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.

  PMID: 23701947 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.

  PMID: 14739871 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.

  PMID: 18378142 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.

  PMID: 17695343 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.

  PMID: 22551994 BACKGROUND

MeSH Terms

Conditions

Trigeminal Nerve Diseases; Trigeminal Nerve Injuries; Cranial Nerve Diseases; Neuralgia; Facial Pain

Interventions

erenumab

Condition Hierarchy (Ancestors)

Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Cranial Nerve Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination due to low enrollment rate. Ultimately we only had one participant in only one group.

Results Point of Contact

• Title: Dr. Marcela Romero Reyes
• Organization: University of Maryland, School of Dentistry

mromero@umaryland.edu

4107067168

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Director Brotman Facial Pain Clinic

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 2, 2021
• Study Start: May 31, 2022
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: March 22, 2024
• Results First Posted: March 22, 2024

Record last verified: 2024-03

Locations

US (1)