The purpose of this Phase 2 study is to evaluate the safety and efficacy of SC MEDI0618 compared to placebo in participants with episodic migraine.
This Phase 2, randomised, multicentre, parallel-group treatment, double-blind, placebo -controlled study is designed to evaluate the safety and efficacy of subcutaneous (SC) MEDI0618 in participants with episodic migraine. The study includes a cohort of participants who have a history of unsuccessful treatment with ≥ 2 small molecule migraine preventive treatments from different classes and are eligible to receive an aCGRP therapy (aCGRP-N) but have not yet done so; The study also includes a smaller cohort of participants who have failed one or more aCGRP therapies (aCGRP-IRs) used for preventative treatment and have a history of unsuccessful treatment with ≥ 2 small molecule migraine preventive treatments from different classes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
488
Efficacy of repeat doses of MEDI0618 in preventing migraine headaches in patients with episodic migraine
Change in number of MHDs from 4-week baseline to last 4 weeks of treatment period.
Time frame: Week 9 to Week 12
Efficacy of repeat doses of MEDI0618 in preventing migraine headaches in patients with episodic migraine as proportion of patients
Participants with at least 50% reduction in number of MHDs in the last 4 weeks of treatment period compared to 4-week baseline.
Time frame: Week 9 to Week 12
Effect of repeat doses of MEDI0618 on disability caused by migraine headaches
Change in MIDAS score from baseline to end of treatment period and to follow-up.
Time frame: Day 1 to Day 85 and to Day 141
Effect of repeat doses of MEDI0618 on disability caused by migraine headaches
Change in HIT-6 score from baseline throughout the treatment period and to follow-up
Time frame: Day 1, Day 29, Day 57 and Day 85 and to Day 141
Effect of repeat doses of MEDI0618 on the severity of migraine headaches
Change in number of moderate or severe MHDs from 4-week baseline to last 4 weeks of treatment period.
Time frame: Week 9 to Week 12
Effect of repeat doses of MEDI0618 on the severity of migraine headaches
Change in number of moderate or severe headache days from 4-week baseline to last 4 weeks of treatment period.
Time frame: Week 9 to Week 12
Effect of repeat doses of MEDI0618 on the severity of migraine headaches
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Flourish - Birmingham
Birmingham, Alabama, United States
RECRUITINGTennessee Valley Neurological Associates PC
Huntsville, Alabama, United States
WITHDRAWNThe Neurology Center of Southern California - Carlsbad Office
La Jolla, California, United States
RECRUITINGClinical Research Institute, LCC
Los Angeles, California, United States
RECRUITINGHomestead Associates in Research, Inc.
Homestead, Florida, United States
NOT_YET_RECRUITINGFlorida Neurology - Lake Mary
Lake Mary, Florida, United States
NOT_YET_RECRUITINGFlourish Research - Miami, LLC dba Flourish Research
Miami, Florida, United States
RECRUITINGBayCare Medical Group Neurology at St. Anthony's Hospital
St. Petersburg, Florida, United States
NOT_YET_RECRUITINGSantos Research Center, Corp - Tampa
Tampa, Florida, United States
RECRUITINGNorton Neuroscience Institute - Headache Clinic
Louisville, Kentucky, United States
WITHDRAWN...and 44 more locations
Change in frequency of use of permitted acute treatment to abort migraine headaches from 4-week baseline to last 4 weeks of the treatment period.
Time frame: Week 9 to Week 12