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13 Trials |  |
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- || Ajovy (fremanezumab) / Otsuka, Teva
Trial completion date, Trial primary completion date: A Study to Test the Effectiveness and Safety of Fremanezumab on Patients With Fibromyalgia (clinicaltrials.gov) - Mar 19, 2021
P2, N=240, Recruiting, Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Trial completion date: Jun 2022 --> Mar 2022 | Trial primary completion date: Jun 2022 --> Mar 2022
- |||| Ajovy (fremanezumab) / Otsuka, Teva
Trial completion date, Trial primary completion date: A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Patients 6 to 17 Years of Age (clinicaltrials.gov) - Mar 18, 2021
P3, N=418, Recruiting, Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Trial completion date: Jun 2022 --> Mar 2022 | Trial primary completion date: Jun 2022 --> Mar 2022 Trial completion date: Apr 2023 --> Dec 2023 | Trial primary completion date: Apr 2023 --> Dec 2023
- Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Calcitonin Gene-Related Peptide Inhibitor Use for Migraine Associated with Exacerbation of Raynaud Phenomenon () - Mar 18, 2021 - Abstract #AAN2021AAN_2760;
Our results indicate that microvascular complications of CGRP antagonist use in patients with underlying RP are uncommon (5.3%). The incidence of serious adverse events, although rare, warrant caution when considering the use of these agents in patients with RP.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Understanding the Impact of Sex and Race on the Migraine Patient’s Journey in the United States: Analyses From an Annual Cross-Sectional Patient Chart Audit () - Mar 18, 2021 - Abstract #AAN2021AAN_2756;
Subgroup disparities reported for the general US population exist and are even more significant in the migraine community. Stakeholders in migraine care should acknowledge and address these disparities.
- Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies in the Treatment of Patients with Concussion () - Mar 18, 2021 - Abstract #AAN2021AAN_1148;
There was a subset of patients with a more robust response. Switching anti-CGRP mAbs was beneficial in some patients.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Single Center Experience of mAbs-CGRP Use for Migraine Prevention () - Mar 18, 2021 - Abstract #AAN2021AAN_1141;
Reasons for stopping included medication failure, adverse effects, and insurance difficulties. Combined use of mAb and OnabotulinumbtoxinA seemed to be a safe and efficacious treatment of migraine.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Effect of Fremanezumab on the Total Burden of Migraine in Patients with Episodic or Chronic Migraine: Findings from 3 Randomized, Double-blind, Placebo-controlled Phase 3 Studies () - Mar 18, 2021 - Abstract #AAN2021AAN_1140;
Combined use of mAb and OnabotulinumbtoxinA seemed to be a safe and efficacious treatment of migraine. Greater reductions in the monthly total migraine burden, including frequency, severity, and duration, were seen with quarterly and monthly fremanezumab versus placebo for patients with EM and CM, including those with difficult-to-treat migraine.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Real-World Adherence, Persistence, Switching, and Reinitiation by Quarterly and Monthly Dosing Regimen in Patients Prescribed AJOVY in US Physician Practices () - Mar 18, 2021 - Abstract #AAN2021AAN_1138;
Greater reductions in the monthly total migraine burden, including frequency, severity, and duration, were seen with quarterly and monthly fremanezumab versus placebo for patients with EM and CM, including those with difficult-to-treat migraine. This real-world study showed treatment adherence and persistence were higher for patients prescribed quarterly versus monthly dosing, with comparable switching and reinitiation rates.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Baseline Comorbidities and Changes in Acute Medication Use by Quarterly and Monthly Dosing Regimen in Patients Prescribed AJOVY in US Physician Practices () - Mar 18, 2021 - Abstract #AAN2021AAN_1137;
This real-world study showed treatment adherence and persistence were higher for patients prescribed quarterly versus monthly dosing, with comparable switching and reinitiation rates. This real-world study showed that comorbidities at baseline were comparable for patients with quarterly and monthly dosing. Patients on quarterly AJOVY were less likely to be prescribed acute medications.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Improvements in Patient-reported Migraine Pain Intensity and Composite Migraine Symptoms With Fremanezumab in the Real World () - Mar 18, 2021 - Abstract #AAN2021AAN_1136;
This real-world study showed that comorbidities at baseline were comparable for patients with quarterly and monthly dosing. Patients on quarterly AJOVY were less likely to be prescribed acute medications. After fremanezumab initiation, MPI decreased significantly and the majority of patients reported an improvement in headache frequency/symptoms.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Real-world Reductions in Migraine and Headache Days for Patients With Chronic and Episodic Migraine Initiating Fremanezumab in the US () - Mar 18, 2021 - Abstract #AAN2021AAN_1135;
After fremanezumab initiation, MPI decreased significantly and the majority of patients reported an improvement in headache frequency/symptoms. In this real-world study, fremanezumab treatment resulted in clinically meaningful reductions in MMDs and MHDs sustained over up to 6 months for both CM and EM patients.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Real-world Adherence, Persistence, Switching, and Reinitiation in Patients Prescribed AJOVY in US Physician Practices () - Mar 18, 2021 - Abstract #AAN2021AAN_1134;
In this real-world study, fremanezumab treatment resulted in clinically meaningful reductions in MMDs and MHDs sustained over up to 6 months for both CM and EM patients. Real-world treatment adherence and persistence were high with AJOVY; the majority of patients who discontinued AJOVY treatment discontinued any treatment or switched to a different preventive treatment class, and several patients restarted AJOVY.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Number Needed to Treat/Harm for Fremanezumab in Patients Who Had Inadequate Response to 2-4 Prior Migraine Preventive Medication Classes () - Mar 18, 2021 - Abstract #AAN2021AAN_1133;
Real-world treatment adherence and persistence were high with AJOVY; the majority of patients who discontinued AJOVY treatment discontinued any treatment or switched to a different preventive treatment class, and several patients restarted AJOVY. The NNT, NNH, and LHH were generally favorable for both fremanezumab dosing regimens in this population with EM or CM and inadequate response to 2-4 prior migraine preventive treatment classes.
- Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Discrete Choice Experiment to Understand Patient Preferences for Self-Injectable Preventive Treatments for Migraine – A quantitative pilot () - Mar 18, 2021 - Abstract #AAN2021AAN_1131;
Patients preferred a profile similar to galcanezumab over profiles of other self-injectable migraine preventive treatments. The preference information may enhance communication about potentially effective migraine preventive treatment options.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] US Real-world Patient Characteristics, Acute Medication Use, and Treatment Patterns for Patients Initiating Fremanezumab () - Mar 18, 2021 - Abstract #AAN2021AAN_1103;
The preference information may enhance communication about potentially effective migraine preventive treatment options. Fremanezumab treatment is associated with statistically significant reductions in acute medication claims and good treatment adherence in the first 12 months of use.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] US Real-world Migraine-related Health Care Resource Utilization and Costs for Patients Initiating Fremanezumab () - Mar 18, 2021 - Abstract #AAN2021AAN_1066;
Fremanezumab treatment is associated with statistically significant reductions in acute medication claims and good treatment adherence in the first 12 months of use. Fremanezumab treatment is associated with statistically significant reductions in migraine-related inpatient, ER, and outpatient visits; acute medication prescriptions; and outpatient and acute medication costs in the first 6 months of use.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Efficacy of Fremanezumab in Patients With Moderate and Higher Frequency Episodic Migraine () - Mar 18, 2021 - Abstract #AAN2021AAN_1062;
Fremanezumab treatment is associated with statistically significant reductions in migraine-related inpatient, ER, and outpatient visits; acute medication prescriptions; and outpatient and acute medication costs in the first 6 months of use. Fremanezumab demonstrated efficacy, based on reductions in MMDs and MHDs versus placebo, with similar therapeutic gains in the MFEM and HFEM groups.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Cardiovascular Safety of Fremanezumab in Patients With Migraine and Cardiovascular Medical History or Risk Factors: A Pooled Analysis of Phase 3 Studies () - Mar 18, 2021 - Abstract #AAN2021AAN_1050;
No CV safety signals were identified. These data support the strong safety profile of this preventive treatment targeting the CGRP pathway.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] US Real-world Effectiveness of Quarterly and Monthly Fremanezumab for Reducing Migraine Days and Headache Days in Adult Patients With Migraine () - Mar 18, 2021 - Abstract #AAN2021AAN_1047;
These data support the strong safety profile of this preventive treatment targeting the CGRP pathway. In this real-world study, both quarterly and monthly fremanezumab resulted in clinically meaningful reductions in MMDs and MHDs over ≤6 months.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] A Phase 2 Study of Fremanezumab as a Treatment for Posttraumatic Headache in Adult Patients () - Mar 18, 2021 - Abstract #AAN2021AAN_1045;
This study did not demonstrate statistical differences between fremanezumab and placebo treatment for any of the efficacy endpoints. Despite being administered at a higher dose than labeled for migraine, safety data for fremanezumab 675 mg monthly was comparable to placebo administration and consistent with the known safety profile of fremanezumab.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Impact of Fremanezumab on Disability Severity in Patients With Episodic and Chronic Migraine: Pooled Results of 3 Randomized, Double-blind, Placebo-controlled Phase 3 Studies () - Mar 18, 2021 - Abstract #AAN2021AAN_1043;
Despite being administered at a higher dose than labeled for migraine, safety data for fremanezumab 675 mg monthly was comparable to placebo administration and consistent with the known safety profile of fremanezumab. This pooled analysis demonstrated that fremanezumab resulted in clinically meaningful improvements in headache- and migraine-related disability severity, further supporting the efficacy of fremanezumab in patients with difficult-to-treat migraine.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Efficacy of Fremanezumab in Patients With Lower and Higher Frequency Chronic Migraine () - Mar 18, 2021 - Abstract #AAN2021AAN_1040;
This pooled analysis demonstrated that fremanezumab resulted in clinically meaningful improvements in headache- and migraine-related disability severity, further supporting the efficacy of fremanezumab in patients with difficult-to-treat migraine. Fremanezumab demonstrated efficacy for CM, based on reductions in MMDs and MHDs versus placebo, regardless of baseline migraine frequency.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Long-term Efficacy of Fremanezumab in Patients With Chronic or Episodic Migraine Who Were Inadequate Responders to Initial Fremanezumab Treatment () - Mar 18, 2021 - Abstract #AAN2021AAN_1039;
Fremanezumab demonstrated efficacy for CM, based on reductions in MMDs and MHDs versus placebo, regardless of baseline migraine frequency. These data show that patients with an inadequate initial response to fremanezumab may experience clinically meaningful reductions in migraine or headache days with continued treatment.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Early Reductions in Headache Severity and Duration With Fremanezumab Treatment in the Randomized, Double-blind Phase 3b FOCUS study () - Mar 18, 2021 - Abstract #AAN2021AAN_1037;
These data show that patients with an inadequate initial response to fremanezumab may experience clinically meaningful reductions in migraine or headache days with continued treatment. After 4 weeks of treatment, quarterly and monthly fremanezumab treatment reduced both headache severity and duration in patients with CM or EM and inadequate response to 2-4 prior migraine preventive medication classes.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Real-World Evidence for Control of Chronic Migraine (CM) in Patients Meeting American Headache Society (AHS) Criteria Who Received Calcitonin Gene?Related Peptide Monoclonal Antibody (CGRPmAb) Therapy Added to OnabotulinumtoxinA Treatment () - Mar 18, 2021 - Abstract #AAN2021AAN_1028;
Design/ This was a retrospective, longitudinal chart review of adults with CM treated at 1 clinic (October 2018–November 2019) with ≥2 consecutive onabotulinumtoxinA cycles before ≥1 month of onabotulinumtoxinA plus CGRPmAb (erenumab, fremanezumab, or galcanezumab) combination treatment. Combination use of onabotulinumtoxinA and CGRPmAb demonstrated clinically meaningful improvements in headache frequency and migraine-related disability compared with onabotulinumtoxinA alone in patients with high baseline MHDs and disability treated according to AHS guidance.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Real-World Evidence for Control of Patients With Chronic Migraine Who Received Calcitonin Gene?Related Peptide (CGRP) Monoclonal Antibody Therapy Added to OnabotulinumtoxinA Treatment () - Mar 18, 2021 - Abstract #AAN2021AAN_1027;
Combination therapy was well tolerated with no new safety signals identified. More real-world studies and controlled trials are needed to further quantify potential benefits of this multimodal treatment paradigm.
- Ajovy (fremanezumab) / Otsuka, Teva
[VIRTUAL] Efficacy in Patients Switching from Quarterly to Monthly Fremanezumab or Maintained on Monthly Fremanezumab Treatment Over 6 Months in the Phase 3b FOCUS Study () - Mar 18, 2021 - Abstract #AAN2021AAN_1023;
More real-world studies and controlled trials are needed to further quantify potential benefits of this multimodal treatment paradigm. Efficacy was comparable in patients switching from quarterly to monthly fremanezumab during the OLE and those maintained on monthly dosing throughout the DBP and OLE.
- Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab) / Amgen, Novartis
[VIRTUAL] Use of Anti-calcitonin Gene-Related Peptide Monoclonal Antibodies in Pediatric Migraine Prevention () - Mar 18, 2021 - Abstract #AAN2021AAN_684;
Preliminary results from our study indicate reduction in headache severity and frequency. As currently approved preventative therapies are limited in the pediatric population, continued investigation towards alternative agents is paramount to improve headache prevention in this group.
- | Ajovy (fremanezumab) / Otsuka, Teva
Trial initiation date: Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL (clinicaltrials.gov) - Mar 17, 2021
P2, N=5, Not yet recruiting, Sponsor: Mayo Clinic
As currently approved preventative therapies are limited in the pediatric population, continued investigation towards alternative agents is paramount to improve headache prevention in this group. Initiation date: Jan 2021 --> Dec 2021
- | Ajovy (fremanezumab) / Otsuka, Teva, Aimovig (erenumab-aooe) / Amgen, Novartis
New trial: Effectiveness of a Health Education Programme for Prevention of Chronic Migraine: A Randomized Clinical Trial (clinicaltrials.gov) - Mar 9, 2021
P=N/A, N=182, Not yet recruiting, Sponsor: Universidad de Zaragoza
- || TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Retrospective data, Review, Journal: Optimal treatment strategy of fremanezumab in migraine prevention: a systematic review with network meta-analysis of randomized clinical trials. (Pubmed Central) - Mar 5, 2021
Collectively, S675mg and 225 mg exhibited the optimal balance between efficacy and safety within three months. Long-term efficacy and safety remain unclear, and future studies should further evaluate the long-term outcomes.
- [VIRTUAL] Incidence of Ischemic Stroke Among Migraineurs on Calcitonin Gene-Related Peptide Inhibitors () - Feb 28, 2021 - Abstract #ISC2021ISC_1343;
This could be related to the avoidance of these medications in patients with known cardiovascular risk factors. Further analyses will be completed on vascular risk factor incidence in these populations as well as multiple regression.
- | Emgality (galcanezumab) / Eli Lilly, Daiichi Sankyo, TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
Journal: CGRP pathway monoclonal antibodies for Cluster Headache. (Pubmed Central) - Feb 23, 2021
Both fremanezumab and galcanezumab trials in chronic cluster headache were terminated after futility analysis predicting failure of both trials to fulfil their primary endpoint. The role of CGRP in cluster headache supports ongoing trials of the remaining CGRP pathway monoclonal antibodies and gepants for preventive and acute treatment.A Panglossian view would include targeting neuropeptides involved in parasympathetic signalling in cluster headache, such as pituitary adenylate cyclase-activating peptide (PACAP); such targets warrant exploration in the search of new cluster headache treatments.
- ||||| Ajovy (fremanezumab) / Otsuka, Teva
Trial completion, Enrollment change: A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients (clinicaltrials.gov) - Jan 28, 2021
P3, N=71, Completed, Sponsor: Otsuka Pharmaceutical Co., Ltd.
The role of CGRP in cluster headache supports ongoing trials of the remaining CGRP pathway monoclonal antibodies and gepants for preventive and acute treatment.A Panglossian view would include targeting neuropeptides involved in parasympathetic signalling in cluster headache, such as pituitary adenylate cyclase-activating peptide (PACAP); such targets warrant exploration in the search of new cluster headache treatments. Active, not recruiting --> Completed | N=50 --> 71
- || TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Journal: A comprehensive overview and safety evaluation of fremanezumab as a preventive therapy for migraine. (Pubmed Central) - Jan 23, 2021
Introduction: Fremanezumab, a humanized monoclonal antibody targeting calcitonin gene-related peptide (CGRP mAb), is a migraine-specific treatment for migraine prevention.Areas covered: This review will briefly discuss other available and emerging CGRP mAbs and the neurophysiology of fremanezumab. The review will focus on phase III trials of the efficacy of fremanezumab for episodic and chronic trials, and a recent pooled safety and tolerability analysis of its use.Expert opinion: Continued efficacy and safety data collection will help guide long-term risk and efficacy counseling in the general population.
- | Botox (onabotulinumtoxin A) / GSK, AbbVie
Journal: Drugs for Migraine. (Pubmed Central) - Jan 23, 2021
The review will focus on phase III trials of the efficacy of fremanezumab for episodic and chronic trials, and a recent pooled safety and tolerability analysis of its use.Expert opinion: Continued efficacy and safety data collection will help guide long-term risk and efficacy counseling in the general population. No abstract available
- | Ajovy (fremanezumab) / Otsuka, Teva
Trial completion date, Trial initiation date, Trial primary completion date: Medicinal vs. Orthotic Comparison for Migraine Prevention: A Double-Blind Study (clinicaltrials.gov) - Jan 22, 2021
P=N/A, N=80, Not yet recruiting, Sponsor: Manhattan Beach Orthodontics
No abstract available Trial completion date: Feb 2021 --> Dec 2021 | Initiation date: Sep 2020 --> Feb 2021 | Trial primary completion date: Jan 2021 --> Apr 2021
- || TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Retrospective data, Journal: Treatment benefit among migraine patients taking fremanezumab: results from a post hoc responder analysis of two placebo-controlled trials. (Pubmed Central) - Jan 16, 2021
P3
Fremanezumab responders achieved clinically meaningful improvements in all outcomes. The magnitude of improvements with fremanezumab across efficacy outcomes was far greater in responders than in the overall trial population, providing insight into expected treatment benefits in participants who respond to fremanezumab in clinical practice.
- || Review, Journal: Immunogenicity of biologic therapies for migraine: a review of current evidence. (Pubmed Central) - Jan 16, 2021
As more CGRP mAb studies are conducted and more long-term follow-up data become available, evidence is increasing that immunogenicity rates of biologic therapies for migraine are low, and adverse events related to ADAs are rare. Taken together, these results add to the growing body of evidence for the safety and tolerability of this class of migraine medications.
- |||| Ajovy (fremanezumab) / Otsuka, Teva
New P4 trial: Fremanezumab, Migraine and Sleep (clinicaltrials.gov) - Jan 4, 2021
P4, N=100, Not yet recruiting, Sponsor: Beth Israel Deaconess Medical Center
- | Journal: CGRP antagonists for decreasing migraine frequency: New options, long overdue. (Pubmed Central) - Jan 2, 2021
But a new set of drugs is available for preventing migraine attacks: erenumab, galcanezumab, fremanezumab, and eptinezumab. These monoclonal antibodies target calcitonin gene-related peptide (CGRP) or its receptors, each a key molecule in the pathophysiology of migraine.
- [VIRTUAL] Tolerability of injectable calcitonin gene-related peptide antagonists in migraine headache () - Dec 26, 2020 - Abstract #ASHP2020ASHP_5072;
The primary outcome of this study is the rate of adverse medication events between erenumab, galcanezumab, and fremanezumab. Secondary outcomes are discontinuation rates and reasons for discontinuation.
- Botox (onabotulinumtoxin A) / GSK, AbbVie
[VIRTUAL] Identifying opportunities for provider education to improve the prophylaxis of migraines in the primary care setting under an accountable care organization () - Dec 26, 2020 - Abstract #ASHP2020ASHP_3323;
Pharmacists play an important role by giving recommendations to providers when patients’ migraine symptoms are not well controlled. In addition, pharmacists can offer provider education regarding drug selection and the impact of acute medication overuse.
- || TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Journal: The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study. (Pubmed Central) - Dec 22, 2020
P3
In addition, pharmacists can offer provider education regarding drug selection and the impact of acute medication overuse. Fremanezumab is effective for prevention of migraine in patients with CM, regardless of MO, and demonstrated a benefit over placebo in reducing MO.
- | Ajovy (fremanezumab) / Otsuka, Teva
Enrollment status: A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents (clinicaltrials.gov) - Dec 20, 2020
P3, N=550, Recruiting, Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Fremanezumab is effective for prevention of migraine in patients with CM, regardless of MO, and demonstrated a benefit over placebo in reducing MO. Enrolling by invitation --> Recruiting
- |||| Ajovy (fremanezumab) / Otsuka, Teva
Clinical: That was a great day, but this has been a greater month; reviewing all those who started their #Ajovy journey to treat #chronicmigraine. So many patients have had amazing life changing reductions in their monthly migraine days @IIHDrBirmingham @StephGreggCNS @uhbtrust (Twitter) - Dec 17, 2020
- | Journal: Prevention of migraine with monoclonal antibodies against CGRP or the CGRP receptor: Addition to the S1 guideline: Therapy of migraine attacks and prevention of migraine. Recommendations of the Germany Society of Neurology and the German Migraine and Headache Society. (Pubmed Central) - Dec 17, 2020
A complete version of this guideline can be found on the website of the Deutsche Gesellschaft für Neurologie (www.dgn.org/leitlinien) and the AWMF (Arbeitsgemeinschaft wissenschaftlicher Medizinischer Gesellschaften). This guideline has been approved by the German Neurological Society (DGN) and the German Migraine and Headache Society (GMHS) and was reviewed by the two societies.
- || TEV-48125 / Teva, Ajovy (fremanezumab) / Otsuka, Teva
Clinical, Journal: LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF FREMANEZUMAB IN MIGRAINE: A RANDOMIZED STUDY. (Pubmed Central) - Dec 16, 2020
P3
This guideline has been approved by the German Neurological Society (DGN) and the German Migraine and Headache Society (GMHS) and was reviewed by the two societies. Fremanezumab quarterly and monthly were well tolerated and demonstrated sustained improvements in monthly migraine days, headache days, and headache-related disability for up to 12 months in patients with migraine.ClinicalTrials.gov: NCT02638103 CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that long-term fremanezumab treatment is safe, well tolerated, and effective at sustaining reductions in monthly migraine and headache days.
- || Reyvow (lasmiditan) / Eli Lilly
PK/PD data, Review, Journal: Pharmacokinetics, Pharmacodynamics and Drug-Drug Interactions of New Anti-Migraine Drugs-Lasmiditan, Gepants, and Calcitonin-Gene-Related Peptide (CGRP) Receptor Monoclonal Antibodies. (Pubmed Central) - Dec 9, 2020
In the case of monoclonal antibodies, the issue of pharmacodynamic interactions related to the modulation of the immune system functions was addressed. It also focuses on the effect of monoclonal antibodies on expression of class Fc gamma receptors (FcγR).
- | Ajovy (fremanezumab) / Otsuka, Teva
Trial completion date, Trial primary completion date: A Study to Test the Effectiveness and Safety of Fremanezumab on Patients With Fibromyalgia (clinicaltrials.gov) - Dec 3, 2020
P2, N=240, Recruiting, Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
It also focuses on the effect of monoclonal antibodies on expression of class Fc gamma receptors (FcγR). Trial completion date: Aug 2021 --> Jun 2022 | Trial primary completion date: Aug 2021 --> Jun 2022