- |||||||||| Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Cardiovascular safety of erenumab in patients with migraine with or without a history of aura (Room Vienna) - Apr 9, 2020 - Abstract #EAN2020EAN_1062; This analysis will provide insights into the patient population enrolled in the first head-to-head trial comparing the tolerability and efficacy of erenumab and topiramate. The vascular safety profile of long-term erenumab treatment was similar in patients both with and without a history of aura and was comparable to that of placebo over 12 weeks, with no increased emergence of events over time.
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[VIRTUAL] Slovenian experience with erenumab (ePoster) - Apr 9, 2020 - Abstract #EAN2020EAN_535; In our experince erenumab is effective and safe for reducing migraine burden in patients with 2 or more failed prophylactic treatments. This is in line with previously published data from clinical randomized studies.
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Trial completion date, Trial primary completion date: OASIS (CM): Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine (clinicaltrials.gov) - Apr 8, 2020 P3, N=286, Recruiting, Trial completion date: May 2025 --> Aug 2025 | Trial primary completion date: May 2024 --> Aug 2024 Trial completion date: May 2025 --> Aug 2025 | Trial primary completion date: May 2024 --> Aug 2024
- |||||||||| sumatriptan succinate / Generic mfg., Aimovig (erenumab) / Amgen, Novartis
Clinical, P1 data, Journal: Phase 1, randomized, parallel-group, double-blind, placebo-controlled trial to evaluate the effects of erenumab (AMG 334) and concomitant sumatriptan on blood pressure in healthy volunteers. (Pubmed Central) - Mar 26, 2020 P1 Conclusion Co-administration of erenumab and sumatriptan had no additional effect on resting blood pressure or on pharmacokinetics of sumatriptan. ClinicalTrials.gov, NCT02741310.
- |||||||||| TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
Preclinical, Journal: Fremanezumab inhibits vasodilatory effects of CGRP and capsaicin in rat cerebral artery - Potential role in conditions of severe vasoconstriction. (Pubmed Central) - Mar 26, 2020 Capsaicin is used as a pharmacological tool to induce secretion of endogenous perivascular CGRP and our studies confirm that the antibody reach the perivascular sensory synaptic cleft and blocks the vasodilatory response of released CGRP in the present in vitro model. Thus, CGRP neutralization might have the mechanistic potential to block vasoprotective responses to severe vasoconstriction provided they reach the site of action and Fremanezumab is an important tool for future investigations of the impact of CGRP physiology.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Trial completion date, Trial primary completion date: Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine (clinicaltrials.gov) - Mar 5, 2020 P4, N=340, Recruiting, The use of erenumab is a cost-effective approach for preventing monthly migraine days among patients with chronic migraine versus onabotulinumtoxin A and no preventive treatment among patients with episodic migraine in the Mexican private health care context. Trial completion date: Apr 2021 --> Mar 2022 | Trial primary completion date: Apr 2021 --> Mar 2022
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Review, Journal: Dawn of a New RAMPage. (Pubmed Central) - Mar 3, 2020 The consequences of these interactions on GPCR function and physiology lays the foundation for new molecular therapeutic targets, as evidenced by the recent success of erenumab. Here, we highlight recent papers that uncovered novel RAMP-GPCR interactions, human RAMP-GPCR disease-causing mutations, and RAMP-related human pathologies, paving the way for a new era of RAMP-targeted drug development.
- |||||||||| Clinical, Journal, HEOR: How much do calcitonin gene-related peptide monoclonal antibodies improve the quality of life in migraine? A patient's perspective. (Pubmed Central) - Feb 24, 2020
Here, we highlight recent papers that uncovered novel RAMP-GPCR interactions, human RAMP-GPCR disease-causing mutations, and RAMP-related human pathologies, paving the way for a new era of RAMP-targeted drug development. CGRP-mABs have an impact on the disability, QoL, workplace productivity and global impression of improvement of migraine, which will translate into changes in the real world of migraine patients who are treated with CGRP-mABs.
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Trial completion date, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache (clinicaltrials.gov) - Feb 23, 2020 P4, N=687, Recruiting, CGRP-mABs have an impact on the disability, QoL, workplace productivity and global impression of improvement of migraine, which will translate into changes in the real world of migraine patients who are treated with CGRP-mABs. Trial completion date: May 2022 --> Dec 2022 | Trial primary completion date: Nov 2021 --> Jun 2022
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Clinical, Review, Journal: Nonclinical safety evaluation of erenumab, a CGRP receptor inhibitor for the prevention of migraine. (Pubmed Central) - Feb 16, 2020 The maternal and developmental no-observed-effect level (NOEL) was the highest dose tested (50 mg/kg SC Q2W). These nonclinical data in total indicate no safety signal of concern to date and provide adequate margins of exposure between the observed safe doses in animals and clinical dose levels.
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Journal, HEOR: Cost-effectiveness of noninvasive vagus nerve stimulation for acute treatment of episodic migraine and role in treatment sequence strategies. (Pubmed Central) - Feb 14, 2020 We conducted a cost-effectiveness analyses for 2 hypothetical scenarios: a primary model for treatment options gammaCore plus standard of care compared to standard of care alone for acute treatment of migraine; and a secondary model for treatment sequence strategies where acute treatment with gammaCore or standard of care each prior to erenumab prevention compared to initiating erenumab prevention with no prerequisite...This was driven by efficacy, improvement in quality of life, and reduction in costs of care associated with successful treatment of migraine attacks. These findings provide new economic evidence to support value forcoverage for gammaCore.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Trial completion date, Trial primary completion date: AMG 334 20160172 Pediatric Migraine PK Study. (clinicaltrials.gov) - Jan 30, 2020 P1, N=60, Recruiting, Trial completion date: Dec 2023 --> May 2025 | Trial primary completion date: Dec 2022 --> May 2024 Trial completion date: Jun 2021 --> Oct 2021 | Trial primary completion date: Jun 2020 --> Jul 2021
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