- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Erenumab-aooe for the Management of Trigeminal Neuropathic Pain. (clinicaltrials.gov) - Dec 14, 2022 P2, N=5, Terminated, Reductions in migraine day frequency accompanying erenumab treatment are associated with changes in resting state functional connectivity and central processing of extracranial painful stimuli that differ from erenumab non-responders. N=40 --> 5 | Trial completion date: Oct 2024 --> Oct 2022 | Recruiting --> Terminated | Trial primary completion date: Apr 2024 --> Oct 2022; Low enrollment rate
- |||||||||| Review, Journal: Effectiveness and Safety of Chronic Migraine Preventive Treatments: A Systematic Literature Review. (Pubmed Central) - Nov 24, 2022
Erenumab has a favorable safety profile, with a low incidence of serious AEs, and sustained efficacy over ≥1 year of follow-up in the treatment of migraine. While substantial real-world evidence supports the long-term effectiveness and safety of onabotulinumtoxinA, real-world data on other preventive treatments of CM are currently limited to short term effectiveness due to their more recent approvals.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Clinical, Retrospective data, Journal: Erenumab versus topiramate: post hoc efficacy analysis from the HER-MES study. (Pubmed Central) - Nov 18, 2022 P4 In addition, the reported impact of migraine on spouses and children of patients was reduced. This post hoc analysis demonstrated significantly superior efficacy of erenumab versus topiramate in achieving a ≥50% reduction in MMD with an early onset of efficacy.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Review, Journal: Preventive migraine treatment in mitochondrial diseases: a case report of erenumab efficacy and literature review. (Pubmed Central) - Nov 18, 2022 Monoclonal antibodies against the calcitonin gene-related peptide (CGRP) or against its receptor are innovative and specific therapies for migraine prophylaxis. This class of drugs is particularly suitable for subjects, such as those suffering from genetically determined mitochondrial dysfunction, in which pharmacological management can represent a challenge due to the nature of these neurogenetic disorders and/or the frequently associated comorbidities.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
Journal: Effectiveness of anti-CGRP monoclonal antibodies on central symptoms of migraine. (Pubmed Central) - Nov 8, 2022 These results aid in supporting the safety profile of CGRP mAbs in the real-world setting and may provide clinicians and patients with additional insight when considering migraine preventive treatments. Anti-calcitonin gene-related peptide antibodies seems to significantly impact brain functions of migraineurs, preventing not only migraine headache but also its anticipatory and accompanying symptoms.
- |||||||||| Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
Journal: Predictors of response to anti-CGRP monoclonal antibodies: a 24-week, multicenter, prospective study on 864 migraine patients. (Pubmed Central) - Nov 2, 2022 A critical evaluation of headache characteristics indicating peripheral or central sensitization may help in predicting responsiveness to antiCGRP mAbs in HFEM and CM. A more precise pain profiling may represent a steppingstone for a mechanism-based approach and personalized treatment of migraine with compounds targeting specific molecular mechanisms.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment closed, Trial completion date: MicroRNA Profile and Erenumab Treatment (clinicaltrials.gov) - Nov 2, 2022 P=N/A, N=40, Active, not recruiting, A more precise pain profiling may represent a steppingstone for a mechanism-based approach and personalized treatment of migraine with compounds targeting specific molecular mechanisms. Recruiting --> Active, not recruiting | Trial completion date: Sep 2022 --> Dec 2022
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Journal: Gestational exposure to erenumab-The outcome of three pregnancies. (Pubmed Central) - Oct 29, 2022 Continuous follow-up and reporting of all exposures are encouraged to gather safety data on pregnant and nursing women and on the development of the newborns. So far, immediately stopping the drug is advised and may contribute to decreasing the potential risks.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Observational data, Journal: Salivary CGRP and Erenumab Treatment Response: Towards Precision Medicine in Migraine. (Pubmed Central) - Oct 26, 2022 Patients with migraine not only have higher CGRP levels compared with HCs, but also the presence of depressive symptoms seems to increase salivary CGRP levels and we have evidence, for the first time, that baseline salivary CGRP concentration is associated with treatment response to erenumab. ANN NEUROL 2022;92:846-859.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Novartis: Time for a paradigm shift in migraine therapy (M 1–2) - Oct 20, 2022 - Abstract #DGN2022DGN_149; What does this mean for everyday clinical practice, what needs to be taken into account and what needs to be recommended? The experiences, recommendations and prospects will be presented by speakers who, without exception, can be regarded as international experts in migraine treatment.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
P4 data, Journal: Post-marketing safety surveillance of erenumab: new insight from Eudravigilance. (Pubmed Central) - Oct 19, 2022 The co-analysis of multiple spontaneous reported databases unveiled undetected disproportionality signals for erenumab in individual databases. Future studies should be conducted to confirm the associations and potential clinical implications.
- |||||||||| Emgality (galcanezumab-gnlm) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
Enrollment open: Monoclonal CGRP Antibodies for Migraine Prevention - a Nationwide Real Life Study (clinicaltrials.gov) - Oct 19, 2022 P=N/A, N=1500, Recruiting, Future observational data will be necessary to better characterize the potential association between real-world use of CGRP inhibitors and incident alopecia in patients with migraine. Not yet recruiting --> Recruiting
- |||||||||| Vyepti (eptinezumab-jjmr) / Teva, Lundbeck
Trial completion date, Trial primary completion date, HEOR, Real-world evidence, Real-world effectiveness, Real-world: EVEC: Real World Effectiveness of Eptinezumab in Participants With Migraine (clinicaltrials.gov) - Oct 5, 2022 P4, N=200, Recruiting, We cannot rule out whether these results are due to a direct effect of erenumab on the central nervous system or an indirect effect secondary to peripheral drug modulation. Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Mar 2023 --> Oct 2023
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Trial completion, Trial completion date, Trial primary completion date: Efficacy of Erenumab on Functional Impact of Migraine (clinicaltrials.gov) - Oct 5, 2022 P4, N=55, Completed, Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Mar 2023 --> Oct 2023 Recruiting --> Completed | Trial completion date: Dec 2021 --> Jun 2022 | Trial primary completion date: Dec 2021 --> Jun 2022
- |||||||||| Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap, Aimovig (erenumab-aooe) / Amgen, Novartis
Journal: Assessment of the relative effectiveness of erenumab compared with onabotulinumtoxinA for the prevention of chronic migraine. (Pubmed Central) - Oct 4, 2022 P2, P3 Among patients that had received ≥3 prior preventive treatments, the odds ratios comparing erenumab vs onabotulinumtoxinA were 1.7 for ≥50% responder rates based on reductions in MHD (p = 0.155) and 1.7 for ≥50% responder rates based on reductions in MMD (p = 0.140).Conclusion These findings suggest directional benefits (although not reaching the threshold of statistical significance) associated with erenumab vs onabotulinumtoxinA for the preventive treatment of CM. Evidence from this study may inform healthcare stakeholders in treatment selection and optimization for patients with CM.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Trial completion date, Trial primary completion date: Erenumab For Treatment of Hemicrania Continua (clinicaltrials.gov) - Sep 30, 2022 P2, N=20, Recruiting, Evidence from this study may inform healthcare stakeholders in treatment selection and optimization for patients with CM. Trial completion date: Sep 2022 --> Aug 2023 | Trial primary completion date: Sep 2022 --> Aug 2023
- |||||||||| Review, Journal: Role of Calcitonin Gene-Related Peptide on the Gastrointestinal Symptoms of Migraine-Clinical Considerations: A Narrative Review. (Pubmed Central) - Sep 23, 2022
In this review, we summarize the epidemiological evidence for associations between migraine and gastrointestinal disorders, consider the possible physiological role of CGRP in these associations, and review the clinical occurrence of gastrointestinal events in patients with migraine receiving CGRP-based therapies and other migraine treatments. Because patients with migraine are at an increased risk of comorbid and treatment-related gastrointestinal effects, we also propose a patient-management strategy to mitigate these effects.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Biomarker, Journal, Real-world evidence: Does MIDAS reduction at 3 months predict the outcome of erenumab treatment? A real-world, open-label trial. (Pubmed Central) - Sep 21, 2022 P MIDAS only partly reflects the 12-month outcome of erenumab treatment in CM, as it excludes more than one third of responders. A criterion based on the alternative consideration of ≥ 50% reduction in MIDAS score or MMDs in the first three months of treatment represents a more precise and inclusive option.
- |||||||||| Trudhesa (dihydroergotamine mesylate intranasal) / Impel NeuroPharma
Exploratory Efficacy of INP104 in Patients Using Concomitant Preventive Migraine Medications () - Sep 19, 2022 - Abstract #PAINWeek2022PAINWeek_190; Safety measures were similar in patients who did or did not use concomitant migraine preventive medications over the 24-week treatment period. Results from this post hoc analysis suggest that INP104 may be an effective and well-tolerated acute medication for migraine in patients who are concurrently using preventive therapies and need effective therapy for acute episodes of migraine despite being on prevention.
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Trial completion date: CHERUB01: Efficacy of Erenumab in Chronic Cluster Headache (clinicaltrials.gov) - Sep 16, 2022 P2, N=118, Recruiting, Results from this post hoc analysis suggest that INP104 may be an effective and well-tolerated acute medication for migraine in patients who are concurrently using preventive therapies and need effective therapy for acute episodes of migraine despite being on prevention. Trial completion date: Jul 2023 --> Apr 2023
- |||||||||| Aimovig (erenumab-aooe) / Amgen, Novartis
Journal: Serum CGRP in migraine patients using erenumab as preventive treatment. (Pubmed Central) - Sep 14, 2022 Lower serum CGRP-LI 2-4 weeks after starting treatment with erenumab was associated with a higher reduction in migraine days after three months of treatment. Although the underlying mechanisms remain to be determined, this suggests that changes in CGRP levels, shortly after starting erenumab, are important for its clinical effect.
- |||||||||| Reyvow (lasmiditan) / Eli Lilly, Daiichi Sankyo, Aimovig (erenumab-aooe) / Amgen, Novartis
Review, Journal: Cardiovascular Disease and Migraine: Are the New Treatments Safe? (Pubmed Central) - Sep 10, 2022 Vasodilation may be an important CGRP-mediated mechanism mid-ischemia especially in patients with small vessel disease; hence, CGRP antagonists should be use with caution in this context. Long-term data is still needed, and prescribers should ensure patients are aware of the limitations of our knowledge at this time, while still offering these effective and well-tolerated treatment options.
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