A Phase 2, Randomised, Multicentre, Parallel-Group Treatment, Double-Blind Study to Investigate the Safety and Efficacy of Subcutaneous MEDI0618 in the Reduction of Migraine Headache Days Compared to Placebo in Adult Participants With Episodic Migraine
AbbVie
Summary
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.
Description
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 preven…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 18 to 70 years of age * Weight ≥ 40 kg and BMI ≥ 18.0 kg/m2. * History of migraine headaches with or without aura, with migraine onset at ≤ 50 years of age and for at least 12 months prior to screening. * At least 12 MHDs over the last 3 months prior to screening. * Participants must fulfil the following criteria for migraine in prospectively collected baseline information during the 4 consecutive weeks of baseline migraine headache data collection prior to Day 1: (a) ≥ 4 and ≤ 14 MHDs per month. (b) On ≥ 4 days, fulfils any of the following criteria: (i) migraine withou…
Interventions
- DrugMEDI0618
MEDI0618 per protocol
- DrugPlacebo
Volume-matched placebo for all arms
Locations (54)
- Flourish - BirminghamBirmingham, Alabama
- Tennessee Valley Neurological Associates PCHuntsville, Alabama
- The Neurology Center of Southern California - Carlsbad OfficeLa Jolla, California
- Clinical Research Institute, LCCLos Angeles, California
- Homestead Associates in Research, Inc.Homestead, Florida
- Florida Neurology - Lake MaryLake Mary, Florida