CHRONIC MIGRAINE (PROGRESS STUDY)
PROGRESS study design1
Patients were randomized to receive for 12 weeks:
●QULIPTA 60 mg (n=262); or
●Placebo (n=259)
Primary efficacy endpoint:
●The change from baseline in mean MMD across the 12-week treatment period
Secondary endpoints:
●The change from baseline in mean monthly headache days
●The proportion of patients achieving a ≥50% reduction from baseline in mean MMD (average over 12 weeks)
Select patient characteristics1
Baseline characteristics:
●Mean age (range): 42 years (18—74)
●Sex: 87% female; 13% male
Inclusion/exclusion criteria:
●Patients were included if they had a diagnosis of chronic migraine (per 2018 ICHD-3 criteria) for at least 1 year;
●A subset of patients (~11%) continued to use one concomitant migraine preventive medication when entering the study (e.g., amitriptyline, propranolol, topiramate); concomitant use of other CGRP receptor antagonists was not permitted for either acute or preventive treatment of migraine;
●Patients could use acute medications during the study using treatments like triptans, ergotamine derivatives, NSAIDs, acetaminophen, and opioids as needed;
●The study excluded patients with myocardial infarction, stroke, or transient ischemic attacks, and significant liver disease within
6 months prior to screening.
PROGRESS study design1
Patients were randomized to receive for 12 weeks:
●QULIPTA 60 mg (n=262); or
●Placebo (n=259)
Primary efficacy endpoint:
●The change from baseline in mean MMD across the 12-week treatment period
Secondary endpoints:
●The change from baseline in mean monthly headache days
●The proportion of patients achieving a ≥50% reduction from baseline in mean MMD (average over 12 weeks)
Select patient characteristics1
Baseline characteristics:
●Mean age (range): 42 years (18—74)
●Sex: 87% female; 13% male
Inclusion/exclusion criteria:
●Patients were included if they had a diagnosis of chronic migraine (per 2018 ICHD-3 criteria) for at least 1 year;
●A subset of patients (~11%) continued to use one concomitant migraine preventive medication when entering the study (e.g., amitriptyline, propranolol, topiramate); concomitant use of other CGRP receptor antagonists was not permitted for either acute or preventive treatment of migraine;
●Patients could use acute medications during the study using treatments like triptans, ergotamine derivatives, NSAIDs, acetaminophen, and opioids as needed;
●The study excluded patients with myocardial infarction, stroke, or transient ischemic attacks, and significant liver disease within 6 months prior to screening.
Safety information
Click here for additional safety information and for a link to the Product Monograph discussing:
●Relevant warnings and precautions regarding patients with severe hepatic impairment, driving and operating machinery, pregnant and nursing women, and geriatrics.
●Conditions of clinical use, adverse reaction, drug interactions and dosing instructions.
Reference:
1. QULIPTA Product Monograph. AbbVie Corporation.
CGRP: calcitonin gene-related peptide; ICHD: International Classification of Headache Disorders; MMD: monthly migraine days;
NSAIDs: nonsteroidal anti-inflammatory drugs.
For more information
For any questions related to QULIPTA, you can contact AbbVie Medical Information at 1 844 241-5011.
QULIPTA and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company, used under license by AbbVie Corporation.
© 2024 AbbVie. All rights reserved.
CGRP: calcitonin gene-related peptide; ICHD: International Classification of Headache Disorders; MMD: monthly migraine days;
NSAIDs: nonsteroidal anti-inflammatory drugs.
For more information
For any questions related to QULIPTA, you can contact AbbVie Medical Information at
1 888 241-5011.
QULIPTA and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company, used under license by AbbVie Corporation.
© 2024 AbbVie. All rights reserved.
CA-QLP-240063A / OC24