***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Importance Galcanezumab ( LY2951742 ) , a monoclonal antibody against calcitonin gene-related peptide ( CGRP ) , is one of a novel class of new medicines for migraine prevention . Objective To assess whether at least 1 dose of galcanezumab was superior to placebo for episodic migraine prevention . Design , Setting , and Participants A r and omized clinical trial was conducted in the United States ( July 7 , 2014 , to August 19 , 2015 ) in clinics of 37 licensed physicians with a specialty including , but not limited to , psychiatry , neurology , internal medicine , and primary care . Subcutaneous injections of galcanezumab , 5 , 50 , 120 , or 300 mg , or placebo were given monthly during the 3-month treatment period . A total of 936 patients were assessed ; 526 did not meet study entry or baseline criteria and 410 patients were r and omly assigned to receive placebo or galcanezumab .  Analyses were conducted on an intent-to-treat population , which included all patients who were r and omized and received at least 1 dose of study drug . Interventions Short-term migraine treatments were allowed as needed except for opioids or barbiturates . Main Outcomes and Measures To determine if at least 1 of the 4 doses of galcanezumab tested was superior to placebo for migraine prevention measured by the mean change from baseline in the number of migraine headache days 9 weeks to 12 weeks after r and omization . Results Of the 936 patients assessed , 410 met entry criteria ( aged 18 - 65 years with 4 - 14 migraine headache days per month and migraine onset prior to age 50 years ) and were r and omized to receive placebo or galcanezumab . For the primary end point , galcanezumab , 120 mg , significantly reduced migraine headache days compared with placebo ( 99.6 % posterior probability −4.8 days ; 90 % BCI , −5.4 to −4.2 days vs 95 % superiority threshold [ Bayesian analysis ] −3.7 days ; 90 % BCI , −4.1 to −3.2 days ) . Adverse events reported by 5 % or more of patients in at least 1 galcanezumab dose group and more frequently than placebo  included injection-site pain , upper respiratory tract infection , nasopharyngitis , dysmenorrhea , and nausea . Conclusions and Relevance Monthly subcutaneous injections of galcanezumab , both 120 mg and 300 mg , demonstrated efficacy ( repeated- measures analysis ) for the preventive treatment of migraine and support further development in larger phase 3 studies . All dosages were safe and well tolerated for the preventive treatment of episodic migraine . Trial Registration clinical trials.gov Identifier : BACKGROUND Migraine remains poorly treated , with few effective preventive drugs available . We assessed the safety and efficacy of LY2951742 , a fully humanised monoclonal antibody to calcitonin gene-related peptide , for migraine prevention . METHODS We did a r and omised , double-blind , placebo-controlled , phase 2 proof-of-concept study at 35 centres in the USA . Patients aged 18 - 65 years with four to 14 migraine headache days per month were r and omly assigned ( 1:1 ) to LY2951742 or placebo by a computerised r and omisation scheme . LY2951742 ( 150 mg ) or placebo were given as a subcutaneous injection once every 2 weeks for 12 weeks . The primary endpoint was the mean change in number of migraine headache days per 28-day period assessed at 9 - 12 weeks . Safety was assessed over 24 weeks , including the 12-week treatment period and the subsequent 12 weeks after study drug administration . Patients and treating investigators were masked to treatment allocation . Analyses were by intention to treat . A mixed-effects model of repeated measures was used , including patient baseline value , treatment , visit , and treatment-by-visit interaction as fixed effects , and patients as r and om effects . Safety measures were analysed according to the treatment received . This study has been completed and is registered with Clinical Trials.gov , NCT01625988 . FINDINGS Between July 31 , 2012 , and Sept 18 , 2013 , 218 patients were r and omly assigned to LY2951742 ( n=108 , but one patient withdrew before treatment ) or placebo ( n=110 ) . The mean change from baseline to week 12 in the number of migraine headache days was -4·2 ( SD 3·1 ; 62·5 % decrease ) in the LY2951742 group compared with -3·0 ( SD 3·0 ; 42·3 % decrease ) in the placebo group ( least-squares mean difference -1·2 , 90 % CI -1·9 to -0·6 ; p=0·0030 ) . Adverse events that occurred more frequently with LY2951742 than with placebo  included injection site pain , erythema , or both ( 21 [ 20 % ] of 107 vs seven [ 6 % ] of 110 ) , upper respiratory tract infections ( 18 [ 17 % ] vs ten [ 9 % ] ) , and abdominal pain ( six [ 6 % ] vs three [ 3 % ] ) . There were two serious adverse events reported in the treatment arm and four in the placebo arm , none of which were deemed to be related to the study drug . INTERPRETATION These results provide preliminary evidence that LY2951742 might be beneficial in migraine prevention and provide support for the role of calcitonin gene-related peptide in the pathogenesis of migraine . Further controlled studies are needed to assess the safety and efficacy of monoclonal calcitonin gene-related peptide antibodies for the preventive treatment of migraine . FUNDING Arteaus Therapeutics Importance Migraine is a disabling neurological disease characterized by severe headache attacks . Treatment options reduce migraine frequency for many patients , but adverse effects lead to discontinuation in many patients . Objective To demonstrate that galcanezumab is superior to placebo in the prevention of episodic migraine with or without aura . Design , Setting , and Participants The EVOLVE-1 ( Evaluation of LY2951742 in the Prevention of Episodic Migraine 1 ) trial was a double-blind , r and omized , placebo-controlled ( January 11 , 2016 , to March 22 , 2017 ) trial comparing galcanezumab ( 120 mg and 240 mg ) vs placebo . Patients received treatments once monthly for 6 months ( subcutaneous injection via prefilled syringe ) and were followed up for 5 months after their last injection . It was a multicenter , clinic-based study involving 90 sites in North America . Participants in the study were adults ( aged 18 to 65 years ) with at least a 1-year history of migraine , 4 to 14 migraine headache days per month and a mean of at least 2 migraine attacks per month within the past 3 months , and were diagnosed prior to age 50 years . During the study , no other preventive medications were allowed . A total of 1671 patients were assessed ; 809 did not meet study entry or baseline criteria , and 858 were included in the intent-to-treat population . Interventions Patients were r and omized ( 2:1:1 ) to monthly placebo , galcanezumab , 120 mg , and galcanezumab , 240 mg . Main Outcomes and Measures The primary outcome was overall mean change from baseline in the number of monthly migraine headache days during the treatment period . Secondary measures included at least 50 % , at least 75 % , and 100 % reduction in monthly migraine headache days , migraine headache days with acute medication use , and scores from the Migraine-Specific Quality of Life question naire , Patient Global Impression of Severity , and Migraine Disability Assessment . Treatment-emergent adverse events and serious adverse events were reported . Results Of the 1671 patients assessed , 858 ( mean age , 40.7 years ; 718 women [ 83.7 % ] ) met study entry criteria and received at least 1 dose of investigational product . The primary objective was met for both galcanezumab doses ; treatment with galcanezumab significantly reduced monthly migraine headache days ( both P < .001 ) by 4.7 days ( 120 mg ) and 4.6 days ( 240 mg ) compared with placebo ( 2.8 days ) . All key secondary objectives were also significant after multiplicity adjustment . There were no meaningful differences between 120-mg and 240-mg doses of galcanezumab on measures of efficacy . Completion rate during treatment was high ( 81.9 % ; n = 718 ) , and the incidence of discontinuation owing to adverse events was less than 5 % across all treatment groups . Conclusions and Relevance Galcanezumab 120-mg and 240-mg monthly injections provided clinical benefits and improved functioning . The incidence rate of adverse events was low , demonstrating the favorable tolerability profile of galcanezumab . Trial Registration Clinical Trials.gov Identifier : Introduction Galcanezumab is a humanized monoclonal antibody binding calcitonin gene-related peptide , used for migraine prevention . Methods A global , double-blind , 6-month study of patients with episodic migraine was undertaken with 915 intent-to-treat patients r and omized to monthly galcanezumab 120 mg ( n = 231 ) or 240 mg ( n = 223 ) or placebo ( n = 461 ) subcutaneous injections . Primary endpoint was overall mean change from baseline in monthly migraine headache days . Key secondary endpoints were ≥50 % , ≥ 75 % , and 100 % response rates ; monthly migraine headache days with acute migraine medication use ; Patient Global Impression of Severity rating ; the Role Function-Restrictive score of the Migraine-Specific Quality of Life Question naire . Results Mean monthly migraine headache days were reduced by 4.3 and 4.2 days by galcanezumab 120 and 240 mg , respectively , and 2.3 days by placebo . The group differences ( 95 % CIs ) versus placebo were 2.0 ( −2.6 , −1.5 ) and 1.9 ( −2.4 , −1.4 ) , respectively . Both doses were superior to placebo for all key secondary endpoints . Injection site pain was the most common treatment-emergent adverse event , reported at similar rates in all treatment groups . Both galcanezumab doses had significantly more injection site reactions and injection site pruritus , and the 240 mg group had significantly more injection site erythema versus placebo . Conclusions Galcanezumab 120 or 240 mg given once monthly was efficacious , safe , and well tolerated . Study identification EVOLVE-2 ; NCT02614196 ; https:// clinical trials.gov/ct2/show/NCT02614196 . Trial Registration NCT02614196 Objective To characterize adult patients with episodic migraine who achieved 100 % response to galcanezumab treatment . Background Galcanezumab is a humanized monoclonal antibody that selectively binds to the calcitonin gene‐related peptide ( CGRP ) and has demonstrated efficacy in reducing migraine headache days ( MHD ) in patients with episodic and chronic migraine . Methods A post hoc analysis of the proportion of patients with 100 % response ( 100 % reduction from baseline in monthly MHD ) was calculated for each month from pooled data of 2 double‐blind , 6‐month galcanezumab studies in patients with episodic migraine ( 4 to 14 MHD and ≥2 migraine attacks per month at baseline ) . The patients were r and omized ( 1:1:2 ) to monthly  subcutaneous galcanezumab , 120 mg ( after 240 mg initial loading dose ) or 240 mg , or placebo . A generalized linear mixed model with effects for baseline MHD , treatment , month , and treatment‐by‐month interaction was used to estimate the mean monthly response rate . Results The analysis included 1739 patients treated with galcanezumab , 120 mg ( n = 436 ) or 240 mg ( n = 428 ) , or placebo ( n = 875 ) .  The mean monthly 100 % response rate on an average month in the 6‐month double‐blind phase was greater for galcanezumab 120 mg ( 13.5 % ) and 240 mg ( 14.3 % ) groups vs placebo ( 5.9 % ) with odds ratios of 2.5 ( 95 % confidence interval [ CI ] 1.9 , 3.2 ) and 2.6 ( 95 % CI 2.0 , 3.4 ) , respectively ( P < .001 ) . The rate of 100 % monthly response increased at each month over the 6‐month double‐blind phase with higher rates for galcanezumab dose groups ( 9 to 21 % ) than place 
    Output:
    
The degree of AEs in all group was mild .
Notably , no significant differences were found in the occurrence of AEs and ADAs  between the galcanezumab and placebo groups .
Galcanezumab is a safe and effective treatment for adult patients with episodic and chronic migraine