Relevant bibliographies by topics / Galcanezumab

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  1. Journal articles
  2. Dissertations / Theses
  3. Book chapters
  4. Conference papers

Academic literature on the topic 'Galcanezumab'

Author: Grafiati
Published: 4 June 2021
Last updated: 1 February 2022

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Journal articles on the topic "Galcanezumab"

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Oakes, Tina Marie Myers, Vladimir Skljarevski, Qi Zhang, William Kielbasa, Michael E. Hodsdon, Holland C. Detke, Angelo Camporeale, and Joel R. Saper. "Safety of galcanezumab in patients with episodic migraine: A randomized placebo-controlled dose-ranging Phase 2b study." Cephalalgia 38, no. 6 (January 8, 2018): 1015–25. http://dx.doi.org/10.1177/0333102417747230.

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Background Safety findings from a Phase 2b study of galcanezumab, a humanized monoclonal antibody against calcitonin gene-related peptide, for prevention of migraine (NCT02163993) are reported here. Methods Patients aged 18–65 years with episodic migraine were evaluated in this multicenter, double-blind, randomized study. After randomization, 410 patients were administered 5, 50, 120 or 300 mg of galcanezumab or placebo subcutaneously once every 4 weeks for 12 weeks, followed by a post-treatment off-drug period lasting 12 weeks. Results Treatment-emergent adverse events (TEAEs) were primarily rated as mild to moderate. Serious adverse events reported in galcanezumab dose groups were appendicitis, Crohn’s disease, suicidal ideation, and congenital ankyloglossia in an infant of a paternal pregnancy; each of these were reported by one patient. Adverse events leading to discontinuation with galcanezumab treatment were abdominal pain, visual impairment, and upper limb fracture, each reported by one patient. Treatment-emergent injection-site reactions were reported significantly more frequently ( p = 0.013) with galcanezumab (13.9%) than with placebo (5.8%). Injection-site pain was the most common injection-site reaction (galcanezumab 11.4%; placebo 2.9%, p = 0.004). Upper respiratory tract infection (galcanezumab 10.0%; placebo 8.8%) and nasopharyngitis (galcanezumab 7.0%; placebo 2.2%) also occurred more frequently with galcanezumab treatment. Potential hypersensitivity events were reported at similar frequencies in galcanezumab (3.3%) and placebo (5.1%) groups. Incidence of treatment-emergent anti-drug antibodies in galcanezumab dose groups (4.6% of patients during treatment period) did not appear to have any meaningful effects on safety, the pharmacokinetics of galcanezumab, or its ability to bind to the target ligand. Conclusion The results from this 3-month Phase 2b study support the initiation of larger Phase 3 trials of longer duration.
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Detke, Holland C., Peter J. Goadsby, Shufang Wang, Deborah I. Friedman, Katherine J. Selzler, and Sheena K. Aurora. "Galcanezumab in chronic migraine." Neurology 91, no. 24 (November 16, 2018): e2211-e2221. http://dx.doi.org/10.1212/wnl.0000000000006640.

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ObjectiveTo evaluate the efficacy and safety of galcanezumab, a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide, in the preventive treatment of chronic migraine.MethodsA phase 3, randomized, double-blind, placebo-controlled study of LY2951742 in patients with chronic migraine (Evaluation of Galcanezumab in the Prevention of Chronic Migraine [REGAIN]) was a phase 3 study with a 3-month double-blind, placebo-controlled treatment phase and a 9-month open-label extension. Eligible patients 18 to 65 years of age with chronic migraine were randomized 2:1:1 to monthly subcutaneous injections of placebo (n = 558), galcanezumab 120 mg (with a 240-mg loading dose, n = 278), or galcanezumab 240 mg (n = 277). The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days (MHDs) during the 3-month double-blind treatment phase.ResultsMean number of monthly MHDs at baseline was 19.4 for the total sample. Both galcanezumab dose groups demonstrated greater overall mean reduction in the number of monthly MHDs compared to placebo (placebo −2.7, galcanezumab 120 mg −4.8, galcanezumab 240 mg −4.6) (p < 0.001 for each dose compared to placebo). There were no clinically meaningful differences between galcanezumab doses and placebo on any safety or tolerability outcome except for a higher incidence of treatment-emergent injection-site reaction (p < 0.01), injection-site erythema (p < 0.001), injection-site pruritus (p < 0.01), and sinusitis (p < 0.05) in the galcanezumab 240-mg group relative to placebo.ConclusionsBoth doses of galcanezumab were superior to placebo in reducing the number of monthly MHDs. Galcanezumab appears efficacious, safe, and well tolerated for the preventive treatment of chronic migraine.ClinicalTrials.gov identifierNCT02614261.Classification of evidenceThis interventional study provides Class I evidence that galcanezumab is superior to placebo in the reduction of the number of monthly MHDs.
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Dodick, David W., Peter J. Goadsby, Christian Lucas, Rigmor Jensen, Jennifer N. Bardos, James M. Martinez, Chunmei Zhou, et al. "Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment." Cephalalgia 40, no. 9 (February 12, 2020): 935–48. http://dx.doi.org/10.1177/0333102420905321.

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Objective To report efficacy and safety of galcanezumab in adults with chronic cluster headache. Background Galcanezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide and inhibits its biological activity. Methods This study comprised a prospective baseline period, a 12-week double-blind, placebo-controlled treatment period, and a 52-week open-label period. Up to six protocol-specified concomitant preventive medications were allowed if patients were on a stable dose for 2 months prior to the prospective baseline period. Patients were randomized 1:1 to monthly subcutaneous galcanezumab (300 mg) or placebo. The primary endpoint was overall mean change from baseline in weekly attack frequency with galcanezumab compared to placebo. Key secondary endpoints were ≥50% response rate and percentage of patients meeting sustained response. Results from the double-blind treatment period are reported. Results A total of 237 patients were randomized and treated (120 placebo; 117 galcanezumab). At baseline, the mean age was 45 years and 63% were using ≥1 preventive drug. The primary endpoint was not met; mean change in weekly attack frequency was −4.6 placebo versus −5.4 galcanezumab ( p = 0.334). Key secondary endpoints also were not met. Injection site-related treatment-emergent adverse events were more common in the galcanezumab than the placebo group, with significantly more injection site erythema. Conclusion Treatment with galcanezumab 300 mg did not achieve its primary and key secondary endpoints. This study underscores the potential distinct biology of cCH as well as the significant unmet need for safe, effective, and well-tolerated preventive treatment. The safety profile of galcanezumab in cCH is consistent with that observed in trials of episodic CH and migraine. Trial registration NCT02438826; https://www.clinicaltrials.gov/ct2/show/NCT02438826 .
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Ruff, Dustin D., Janet H. Ford, Antje Tockhorn-Heidenreich, Matthew Sexson, Sriram Govindan, Eric M. Pearlman, Shuu-Jiun Wang, Arif Khan, and Sheena K. Aurora. "Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure." Cephalalgia 39, no. 8 (May 19, 2019): 931–44. http://dx.doi.org/10.1177/0333102419847957.

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Background Efficacy of galcanezumab in chronic migraine has been demonstrated in a pivotal Phase 3 study. Here, we assess efficacy in patients who have failed ≥2 and ≥1 prior migraine preventives for efficacy and/or safety reasons, and in those who never failed. Study design/methods REGAIN (NCT02614261) was a Phase 3, randomized, double-blind, placebo-controlled study in patients with chronic migraine. Patients were randomized 2:1:1 to receive placebo, galcanezumab 120 mg/240 mg once monthly during a double-blind treatment period lasting three months. Subgroup analyses were conducted among patients who failed ≥2 and ≥1 prior preventives and who never failed previously. Outcomes assessed were change from baseline in number of monthly migraine headache days, proportion of patients with ≥50% and ≥75% response (reduction in monthly migraine headache days), change in number of monthly migraine headache days with acute medication use and change in patient functioning per Migraine-Specific Quality of Life Questionnaire Role Function Restrictive (MSQ RF-R) domain score. Results Treatment with galcanezumab versus placebo resulted in significant improvements ( p < 0.01) in overall reduction (Months 1–3) from baseline in the number of monthly migraine headache days in patients with prior failures (LS mean change [SE]: ≥2 prior failures: galcanezumab 120 mg: −5.35 (0.71); galcanezumab 240 mg: −2.77 (0.66); placebo: −1.01 (0.54); ≥1 prior failures: galcanezumab 120 mg: −5.53 (0.60), galcanezumab 240 mg: −3.53 (0.59); placebo: −2.02 (0.49). Similarly, significant results were seen with galcanezumab versus placebo for ≥50% and ≥75% response rates, reductions in acute medication use and improvements in MSQ RF-R domain score. In the subgroup with no prior preventive failures, results were statistically significant for the 240 mg galcanezumab group versus placebo on all outcome measures, and for the 120 mg group on the reduction in migraine headache days with acute medication use. There was also a higher placebo response observed in the patients with no prior preventive failures. Conclusion Galcanezumab is consistently efficacious versus placebo in reducing monthly migraine headache days and several other key outcomes in patients with chronic migraine who have failed ≥2 or ≥1 preventives previously. In the subgroup with no prior failures, greater numerical differences were seen with galcanezumab, but statistical separation from placebo varied by dose and outcome. Clinicaltrials.gov identifier number NCT02614261.
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red. "Rabattverträge für Galcanezumab." NeuroTransmitter 30, no. 10 (October 2019): 59. http://dx.doi.org/10.1007/s15016-019-6873-7.

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red. "Zulassung für Galcanezumab." NeuroTransmitter 30, no. 3 (March 2019): 46. http://dx.doi.org/10.1007/s15016-019-6694-8.

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red. "Rabattverträge für Galcanezumab." Schmerzmedizin 35, no. 5 (September 2019): 57. http://dx.doi.org/10.1007/s00940-019-1168-4.

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red. "Zulassung für Galcanezumab." DNP - Der Neurologe & Psychiater 20, no. 2 (March 29, 2019): 69. http://dx.doi.org/10.1007/s15202-019-2177-9.

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red. "Rabattverträge für Galcanezumab." DNP - Der Neurologe & Psychiater 20, no. 6 (December 2019): 116. http://dx.doi.org/10.1007/s15202-019-2324-3.

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Goadsby, Peter J., David W. Dodick, James M. Martinez, Margaret B. Ferguson, Tina M. Oakes, Qi Zhang, Vladimir Skljarevski, and Sheena K. Aurora. "Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis." Journal of Neurology, Neurosurgery & Psychiatry 90, no. 8 (April 19, 2019): 939–44. http://dx.doi.org/10.1136/jnnp-2018-320242.

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Background and objectiveAs new migraine prevention treatments are developed, the onset of a preventive effect, how long it is maintained and whether patients initially non-responsive develop clinically meaningful responses with continued treatment can be assessed.MethodsAnalyses were conducted post-hoc of a double-blind, placebo-controlled, phase II-a study in patients with episodic migraine receiving galcanezumab 150 mg or placebo biweekly for 12 weeks (Lancet Neurol 13:885, 2014). The number of migraine headache days per week, and onset of efficacy measured as the first week galacanezumab separated from placebo were determined. Patients with ≥50%, ≥75% and 100% reduction in migraine headache days from baseline at months 1, 2 and 3 were calculated and defined as sustained responses. Non-responders (<50% response) at month 1 or 2 who then showed ≥50%, ≥75% and 100% response at later time-points were calculated.ResultsPatients were randomised to galcanezumab (n=107) or placebo (n=110). A significant (p=0.018) change of −0.89±0.11 (galcanezumab) vs −0.53±0.11 (placebo) migraine headache days indicated onset at week 1. Forty-seven per cent of galcanezumab and 25% of placebo patients responding at month 1 maintained response through months 2 and 3. Of non-responders at month 1, 27% on galcanezumab and 20% on placebo responded on months 2 and 3, and 50% of galcanezumab non-responders in months 1 and 2 responded on month 3, vs 24% on placebo.ConclusionsThe onset of efficacy of galcanezumab is within 1 week in a majority of patients, and patients receiving galcanezumab are twice more likely to maintain responses than placebo patients. Early non-responders may respond by month 2 or month 3.Trial registration numberNCT01625988.
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Dissertations / Theses on the topic "Galcanezumab"

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Gröhn, Jenny. "CGRP-hämmare i form av monoklonala antikroppar som profylax mot episodisk och kronisk migrän." Thesis, Linnéuniversitetet, Institutionen för kemi och biomedicin (KOB), 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:lnu:diva-93260.

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Background: Migraine is a common disease with a global prevalence of about 15%. Migraine is divided into two main types; migraine with aura or migraine without aura. Migraine symptoms include moderate or severe unilateral pulsating pain exacerbated by physical activity, nausea and vomiting as well as light and sound sensitivity. Headaches lasting ≥ 15 days per month of which ≥ 8 of the days are migraine are defined as chronic migraine. Episodic migraine is defined as less than 15 headache days per month. The full reasons for how and why migraine arises are not yet fully understood. The main hypothesis is that migraine is due to a hypersensitivity in the brain that involves activating and sensitizing the trigeminovascular system. Calcitonine-related peptide (CGRP) has been shown to be an important neurotransmitter in the pathophysiology of migraine that mediates pain through vasodilation of intracranial vessels and an increased sensitivity of A-δ fibers. New drugs in the form of monoclonal antibodies directed against CGRP or the CGRP receptor have been developed to try to stop the CGRP signaling. Currently, there are four approved drugs: galcanezumab, fermanezumab and eptinezumab, which are three monoclonal antibodies directed against CGRP and erenumab which is a monoclonal antibody directed against the CGRP receptor. Purpose: The purpose of this literature study was to investigate how effective treatment with the monoclonal antibodies erenumab, fremanezumab, galcanezumab and eptinezumab directed against CGRP or the CGRP receptor is as prophylaxis against episodic and chronic migraine versus placebo. Method: A literature study was performed by reviewing articles retrieved from the Pubmed database. A free text search was done in Pubmed with the keywords "fremanezumab" OR "eptinezumab" OR "galcanezumab" OR "erenumab". The studies should be randomized, double-blind and placebo-controlled with the aim of investigating the efficacy and tolerability of treatment with erenumab, fremanezumab, galcanezumab or erenumab. A total of eight studies were selected for review. Results: Two studies reviewed erenumab, three studies reviewed fremanezumab, two studies reviewed galcanezumab and one study reviewed eptinezumab. The results showed that all four substances significantly reduced the number of migraine days per month compared to placebo with a mean change of −2.1. Number needed to treat (NNT) to produce ≥ 50 % reduction in migraine frequency varied between 4 – 33 in the eight studies. Conclusion: The results of the eight studies showed that treatment with erenumab, fremanezumab, galcanezumab or eptinezumab in patients with chronic and episodic migraine significantly reduce the number of migraine days per month compared to placebo. The treatments have been well tolerated and there have been relatively few side effects that have been comparable to placebo. However, more long-term studies need to be done to detect any long-term side effects.
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Book chapters on the topic "Galcanezumab"

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Reuter, Uwe, and Bianca Raffaelli. "Galcanezumab." In Monoclonal Antibodies in Headache, 99–108. Cham: Springer International Publishing, 2021. http://dx.doi.org/10.1007/978-3-030-69032-8_7.

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Conference papers on the topic "Galcanezumab"

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Morego Soler, A., MA Maestre Fullana, V. Cano Collado, N. Galan Ramos, A. Trujullano Ruiz, F. Perello Rossello, MM Crespi Magro, et al. "4CPS-354 Efficacy and safety with erenumab and galcanezumab: our experience." In 25th Anniversary EAHP Congress, Hospital Pharmacy 5.0 – the future of patient care, 23–28 March 2021. British Medical Journal Publishing Group, 2021. http://dx.doi.org/10.1136/ejhpharm-2021-eahpconf.186.

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Mcnearney, TA, C. Smith, R. Brown, A. Camporeale, M. Deeg, D. Montieth, EC Collins, et al. "SAT0548 Plasma CGRP concentrations were not associated with patient OA symptoms or response to galcanezumab, a monoclonal antibody against CGRP." In Annual European Congress of Rheumatology, 14–17 June, 2017. BMJ Publishing Group Ltd and European League Against Rheumatism, 2017. http://dx.doi.org/10.1136/annrheumdis-2017-eular.2155.

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