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Monoclonal Antibodies

MEDI0618 for Migraine (AURORA Trial)

Phase 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 and 70 years

Weight equal to or greater than 40 kg and BMI equal to or greater than 18.0 kg/m2

Must not have

History of specific migraine sub-types

History of non-migraine headaches within 3 months prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 84 and to day 141

Summary

"This trial aims to see if SC MEDI0618 is safe and effective for treating episodic migraine compared to a placebo."

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

While specific side effects of MEDI0618 aren't listed, common side effects from similar migraine treatments include injection site reactions, nausea, fatigue, and dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I weigh at least 40 kg and my BMI is 18 or higher.

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I have tried and not responded to 3 different migraine prevention medications.

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I have had 12 or more migraine days in the last 3 months.

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I have been diagnosed with migraines based on recent assessments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of certain types of migraines.

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I have had non-migraine headaches in the last 3 months.

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I have a history of abnormal heart rhythms or QT syndrome.

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I am currently using opioids or medications that contain barbiturates for pain.

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I need to take specific biological treatments during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 84 and to day 141

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 84 and to day 141

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 84 and to day 141 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of repeat doses of MEDI0618 in preventing migraine headaches in patients with episodic migraine

Secondary study objectives

Effect of repeat doses of MEDI0618 on disability caused by migraine headaches

Effect of repeat doses of MEDI0618 on the severity of migraine headaches

Efficacy of repeat doses of MEDI0618 in preventing migraine headaches in patients with episodic migraine as proportion of patients

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: CGRP-N_MEDI0618 (Dose D)Experimental Treatment1 Intervention

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.

Group II: CGRP-N_MEDI0618 (Dose C)Experimental Treatment1 Intervention

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.

Group III: CGRP-N_MEDI0618 (Dose B)Experimental Treatment1 Intervention

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.

Group IV: CGRP-N_MEDI0618 (Dose A)Experimental Treatment1 Intervention

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.

Group V: CGRP-IR_MEDI0618 (Dose A)Experimental Treatment1 Intervention

In the CGRP-IR cohort there will be 1:1 randomisation of participants to the two arms (60 to MEDI0618 and 60 to placebo) .

Group VI: CGRP-N_PlaceboPlacebo Group1 Intervention

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.

Group VII: CGRP-IR_PlaceboPlacebo Group1 Intervention

In the CGRP-IR cohort there will be 1:1 randomisation of participants to the two arms (60 to MEDI0618 and 60 to placebo).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MEDI0618

2019

Completed Phase 1

~100

0 / 10Eligibility criteria met