MEDI0618 for Migraine

(AURORA Trial)

Not currently recruiting at 56 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new treatment, MEDI0618, for individuals with episodic migraines. The study compares different doses of MEDI0618 to a placebo to determine its ability to reduce migraine headaches. Individuals who experience 4 to 14 migraine days per month and have tried at least three different preventive migraine treatments without success may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's efficacy in an initial, smaller group of participants.

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.

Is there any evidence suggesting that MEDI0618 is likely to be safe for humans?

Research shows that MEDI0618 is being tested as a potential treatment for migraines. Earlier studies have examined its safety and effectiveness. Detailed information on side effects is not yet available, but this treatment is an antibody targeting a protein called PAR2. It works by blocking certain pathways in the body that might cause migraines.

The trial is in the middle stages, indicating that earlier results were promising enough to warrant further testing, though its safety is still under review. Treatments reaching this phase are generally considered reasonably safe, but ongoing research is necessary to confirm this. Prospective participants should know that while the treatment appears promising, its full safety profile is still under investigation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for migraine?

Researchers are excited about MEDI0618 for migraine treatment because it targets the calcitonin gene-related peptide (CGRP) pathway, a novel approach compared to many existing treatments. Current standard treatments often focus on pain relief or prevention through medications like triptans or beta-blockers, which can have varying effectiveness and side effects. MEDI0618's unique mechanism specifically blocks CGRP, a protein linked to migraine attacks, potentially reducing frequency and severity with fewer side effects. This focus on the CGRP pathway offers new hope for those who haven't found relief with traditional treatments.

What evidence suggests that this trial's treatments could be effective for migraine?

Research has shown that MEDI0618, which participants in this trial may receive, may help reduce migraine symptoms. In lab tests, MEDI0618 effectively lessened migraine signs in all situations studied. The treatment works by blocking a specific protein believed to contribute to migraines. Although information from human studies remains limited, these early results offer promise for people with occasional migraines. ^{1 2 3 4 6}

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.

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 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?

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?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

AstraZeneca

Industry 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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11967467/

Efficacy of MEDI0618, a pH-dependent monoclonal antibody ... Further, blockade of PAR2 with MEDI0618 was effective in all preclinical migraine models studied but not in a model of post-traumatic headache.

2. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D7060C00003

A study to investigate the safety and efficacy of MEDI0618 ... 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.

3. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=D7060C00003

A Study to Investigate the Safety and Efficacy of MEDI0618 ... 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.

4. academic.oup.com academic.oup.com/brain/article-abstract/148/4/1345/8045723

Efficacy of MEDI0618, a pH-dependent monoclonal antibody ... Further, blockade of PAR2 with MEDI0618 was effective in all preclinical migraine models studied but not in a model of post-traumatic headache.

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-medi0618-for-reducing-migraine-days-in-adults-with-episodic-migraine/

Study on the Safety and Effectiveness of MEDI0618 ... The purpose of the study is to see if MEDI0618 can help reduce the number of migraine headache days in adults who experience these types of ...

6. synapse.patsnap.com synapse.patsnap.com/drug/30ef7f91d8da41eda8f0e67117cb25ff

MEDI-0618 - Drug Targets, Indications, Patents These data indicate that MEDI0618 is a potent and selective inhibitor of PAR2 that is effective in human and rodent in vitro cell systems.