12 Participants Needed

MEDI0618 for Migraine

(AURORA Trial)

Recruiting at 49 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking migraine preventive medications and certain other drugs before and during the study. You must also avoid using opioids or barbiturates more than twice a month and maintain stable doses of any allowed medications for at least 3 months before the study.

Are You a Good Fit for This Trial?

This trial is for adults who experience episodic migraines. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

I weigh at least 40 kg and my BMI is 18 or higher.
I have had 12 or more migraine days in the last 3 months.
I have headaches from using too much medication.
See 5 more

Exclusion Criteria

History of drug or alcohol abuse within 1 year of screening, or positive test at screening
History of severe allergies, hypersensitivity reactions, or hypersensitivity to immunisations or immunoglobulins
Significant psychiatric disorders that may compromise safety or data interpretation
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous MEDI0618 or placebo to evaluate safety and efficacy in reducing migraine headache days

12 weeks
Regular visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks
Follow-up visits to assess long-term effects

What Are the Treatments Tested in This Trial?

Interventions

  • MEDI0618
Trial Overview The study is testing the safety and effectiveness of a drug called MEDI0618 against a placebo in reducing the frequency or severity of migraine episodes. It's given by subcutaneous injection (SC).
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Placebo Group
Group I: CGRP-N_MEDI0618 (Dose D)Experimental Treatment1 Intervention
Group II: CGRP-N_MEDI0618 (Dose C)Experimental Treatment1 Intervention
Group III: CGRP-N_MEDI0618 (Dose B)Experimental Treatment1 Intervention
Group IV: CGRP-N_MEDI0618 (Dose A)Experimental Treatment1 Intervention
Group V: CGRP-IR_MEDI0618 (Dose A)Experimental Treatment1 Intervention
Group VI: CGRP-N_PlaceboPlacebo Group1 Intervention
Group VII: CGRP-IR_PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

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