MEDI0618 for Migraine

(AURORA Trial)

Recruiting at 49 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Must not be taking: Opioids, Barbiturates, Botox, others

Disqualifiers: Severe allergy, Psychiatric disorder, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

12 Participants Needed

Trial Summary

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.

Eligibility Criteria

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 am between 18 and 70 years old.

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.

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

Timeline

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

Treatment Details

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).

Participant Groups

Group I: CGRP-N_MEDI0618 (Dose D) Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 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 Treatment 1 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_Placebo Placebo Group 1 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_Placebo Placebo Group 1 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).

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