A Multicenter, Open-Label Study to Evaluate Satisfaction and Menopausal Quality of Life in Women Using Transdermal Estradiol/Norethindrone Acetate Therapy for the Management of Menopausal Signs and Symptoms

2005 ◽  
Vol 59 (4) ◽  
pp. 212-219 ◽  
Author(s):  
George Adler ◽  
Douglas Young ◽  
Ron Galant ◽  
Laura Quinn ◽  
Mary Sue Witchger ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Signs And Symptoms ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Transdermal Estradiol ◽  
Norethindrone Acetate

scholarly journals Functional impairment and disability among patients with migraine: evaluation of galcanezumab in a long-term, open-label study

2020 ◽  
Author(s):  
Janet H. Ford ◽  
Virginia L. Stauffer ◽  
Peter McAllister ◽  
Sreelatha Akkala ◽  
Matthew Sexson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Treatment Phase ◽  
Phase Iii ◽  
Life Questionnaire ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Patient Reported ◽  
Domain Scores

Abstract Purpose Migraine can negatively impact patient functioning and quality of life. Here, we report the effects of galcanezumab (GMB), a humanized monoclonal antibody that binds to calcitonin gene-related peptide, on patient-reported outcome (PRO) measures in migraine. Methods CGAJ was a Phase III, randomized, open-label study (12-month open-label and 4-month post-treatment follow-up) in patients with episodic or chronic migraine. Patients aged 18–65 years with diagnosis of migraine (≥ 4 migraine headache days per month) as defined by International Classification of Headache Disorders (ICHD)-3 beta guidelines were included in the study. Patients were randomized 1:1 with subcutaneous GMB 120 mg (with a loading dose of 240 mg) or GMB 240 mg given once monthly for 12 months. Changes from baseline in PRO measures such as Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ) and Migraine Disability Assessment (MIDAS) were assessed. Results A total of 135 patients were randomized to each galcanezumab dose group. Mean (SD) baseline MSQ total scores were 53.85 (20.34) [GMB 120 mg] and 53.69 (18.79) [GMB 240 mg]. For MIDAS, mean (SD) total scores were 45.77 (42.06) [GMB 120 mg] and 53.96 (61.24) [GMB 240 mg]. Within-group mean improvement from baseline on MSQ and MIDAS total scores and all individual item/domain scores were statistically significant for both GMB dose groups, at all-time points during the treatment phase (p < 0.001). For MSQ domain scores, greatest improvement was observed in the Role function-restrictive (RF-R) domain (overall least squares (LS) mean change ± SE: 31.55 ± 1.20 [GMB 120 mg] and 33.40 ± 1.16 [GMB 240 mg]). For MIDAS, the overall LS mean change ± SE from baseline across the entire 12-month treatment phase in total scores were: −33.58 ± 2.11 (GMB 120 mg) and −32.67 ± 2.04 (GMB 240 mg). Conclusion Galcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period. These results indicate improved health-related quality of life and decreased disability among patients treated with galcanezumab.

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