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
Status: Recruiting
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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 without aura; (ii) migraine with an aura symptom accompanied or followed by a headache within 60 minutes; (iii) probable migraine; (iv) recurrent attacks that do not match ICHD criteria for migraine but successfully respond to migraine-specific medication.
• Participants who fulfil criteria for MOH are eligible for this study.
• History of unsuccessful treatment with ≥ 3 small molecule migraine preventive treatments from different classes (a) aCGRP-N participants are eligible to receive an aCGRP therapy but must have not yet received aCGRP therapy at any time. (b) aCGRP-IR participants must have tried and have failed at least one aCGRP therapy.
• Participants must be able to distinguish migraine headaches from tension-type headaches.
• Female participants who are not pregnant and do not plan to become pregnant during the study, are not lactating, or are of nonchildbearing potential. FOCBP who are sexually active with a non-sterilised male partner must use adequate contraception consisting of two highly effective methods of contraception throughout the study. FOCBP must agree to comply with protocol specified guidance for safe administration of MEDI0618.
Locations
United States
Alabama
Research Site
RECRUITING
Birmingham
Research Site
WITHDRAWN
Huntsville
California
Research Site
RECRUITING
Carlsbad
Research Site
RECRUITING
Los Angeles
Connecticut
Research Site
WITHDRAWN
Stamford
Florida
Research Site
ACTIVE_NOT_RECRUITING
Homestead
Research Site
RECRUITING
Lake Mary
Research Site
RECRUITING
Miami
Research Site
ACTIVE_NOT_RECRUITING
St. Petersburg
Research Site
RECRUITING
Tampa
Georgia
Research Site
WITHDRAWN
Savannah
Kentucky
Research Site
WITHDRAWN
Louisville
Michigan
Research Site
WITHDRAWN
Ann Arbor
New York
Research Site
WITHDRAWN
New York
Rhode Island
Research Site
RECRUITING
East Greenwich
South Carolina
Research Site
RECRUITING
Summerville
Texas
Research Site
RECRUITING
Austin
Wisconsin
Research Site
RECRUITING
Mequon
West Virginia
Research Site
RECRUITING
Crab Orchard
Other Locations
Denmark
Research Site
SUSPENDED
Glostrup Municipality
Germany
Research Site
NOT_YET_RECRUITING
Berlin
Research Site
SUSPENDED
Chemnitz
Research Site
NOT_YET_RECRUITING
Dresden
Research Site
NOT_YET_RECRUITING
Essen
Research Site
NOT_YET_RECRUITING
Frankfurt Am Main
Research Site
WITHDRAWN
Kiel
Research Site
WITHDRAWN
Munich
Research Site
NOT_YET_RECRUITING
Munich
Hungary
Research Site
SUSPENDED
Budapest
Research Site
SUSPENDED
Budapest
Research Site
SUSPENDED
Dunaújváros
Italy
Research Site
SUSPENDED
Milan
Research Site
SUSPENDED
Pavia
Research Site
NOT_YET_RECRUITING
Roma
Research Site
NOT_YET_RECRUITING
Roma
Netherlands
Research Site
NOT_YET_RECRUITING
Leiden
Poland
Research Site
SUSPENDED
Bydgoszcz
Research Site
SUSPENDED
Katowice
Research Site
SUSPENDED
Krakow
Research Site
SUSPENDED
Krakow
Research Site
SUSPENDED
Lublin
Research Site
SUSPENDED
Poznan
Research Site
SUSPENDED
Poznan
Research Site
SUSPENDED
Warsaw
Research Site
SUSPENDED
Warsaw
Research Site
SUSPENDED
Warsaw
Spain
Research Site
SUSPENDED
Badajoz
Research Site
SUSPENDED
Barcelona
Research Site
SUSPENDED
Barcelona
Research Site
SUSPENDED
Madrid
Research Site
SUSPENDED
Valencia
Research Site
SUSPENDED
Valencia
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date:2024-10-07
Estimated Completion Date:2027-05-07
Participants
Target number of participants:408
Treatments
Experimental: CGRP-N_MEDI0618 (Dose A)
In the CGRP-N cohort, there will be 1:1 randomisation to the MEDI0618 and placebo arms until 32 participants have been randomised per arm (32 MEDI0618 Dose A and 32 to placebo) triggering the interim analysis. After 32 participants/arm have been randomised, the randomization will continue with 28 participants on active dose arm.
Placebo_comparator: CGRP-N_Placebo
In the CGRP-N cohort, there will be 1:1 randomisation to the MEDI0618 Dose A and placebo arms until 32 participants have been randomised per arm (32 to MEDI0618 Dose A and 32 to placebo) triggering the interim analysis. After 32 participants/arm have been randomised, the randomization will continue with 28 participants with corresponding volume matched placebo for all arms.
Experimental: CGRP-N_MEDI0618 (Dose B)
After 32 participants/arm have been randomized in the Dose A and placebo arms, the randomization will continue with 56 participants on active dose arm.
Experimental: CGRP-N_MEDI0618 (Dose C)
After 32 participants/arm have been randomized in the Dose A and placebo arms, the randomization will continue with 56 participants on active dose arm.
Experimental: CGRP-N_MEDI0618 (Dose D)
After 32 participants/arm have been randomized in the Dose A and placebo arms, the randomization will continue with 56 participants on active dose arm.
Experimental: CGRP-IR_MEDI0618 (Dose A)
In the CGRP-IR cohort there will be 1:1 randomisation of participants to the two arms (60 to MEDI0618 and 60 to placebo) .
Placebo_comparator: CGRP-IR_Placebo
In the CGRP-IR cohort there will be 1:1 randomisation of participants to the two arms (60 to MEDI0618 and 60 to placebo).