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Calcitonin Gene-Related Peptide (CGRP) Antagonist

Group D: Lu AG09222 for Migraine (PROCEED Trial)

Phase 2

Recruiting

Research Sponsored by H. Lundbeck A/S

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to week 12 (weeks 1-12)

Awards & highlights

PROCEED Trial Summary

This trial aims to find the right doses of Lu AG09222 to prevent migraines in people who have tried other medications without success.

Who is the study for?

This trial is for adults who have suffered from migraines for over a year, get them at least 4 days each month, and haven't found relief with 2-4 other preventive medications. They must have been diagnosed according to specific guidelines and had their first migraine before turning 51.Check my eligibility

What is being tested?

The study is testing different doses of a new medication called Lu AG09222 against a placebo to see which dose might prevent migraines in people who didn't respond well to previous treatments. Participants will be randomly assigned to receive either the drug or placebo.See study design

What are the potential side effects?

While the side effects of Lu AG09222 are not detailed here, common side effects in trials like this may include reactions at the injection site, nausea, fatigue, and possibly others depending on how individuals react to the medication.

PROCEED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to week 12 (weeks 1-12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to week 12 (weeks 1-12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 12 (weeks 1-12) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline in the Number of Monthly Migraine Days (MMDs)

Secondary outcome measures

Change From Baseline in MMDs

Change from Baseline in the Number of Monthly Headache Days

Number of Participants with Anti-drug Antibodies (ADA)

+3 more

PROCEED Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Group E: Lu AG09222Experimental Treatment1 Intervention

Participants will receive 2 injections, each containing Lu AG09222.

Group II: Group D: Lu AG09222Experimental Treatment2 Interventions

Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.

Group III: Group C: Lu AG09222Experimental Treatment2 Interventions

Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.

Group IV: Group B: Lu AG09222Experimental Treatment2 Interventions

Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.

Group V: Group A: PlaceboPlacebo Group1 Intervention

Participants will receive 2 injections of placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Lu AG09222

2022

Completed Phase 2

~350

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor

325 Previous Clinical Trials

77,085 Total Patients Enrolled

12 Trials studying Migraine

4,288 Patients Enrolled for Migraine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants involved in this research endeavor?

"Correct. The details on clinicaltrials.gov indicate that this medical study is actively seeking volunteers. It was initially uploaded on April 1, 2024, and the latest revision was made on April 15, 2024. The trial aims to recruit a total of 498 participants at one designated site."

Answered by AI

What are the potential risks associated with using Group D: Lu AG09222 in individuals?

"According to our assessment at Power, the safety rating for Group D: Lu AG09222 is 2 on a scale of 1 to 3. This evaluation stems from being in Phase 2 where there exists initial data supporting safety without evidence yet backing efficacy."

Answered by AI

Are there any current opportunities for individuals to participate in this ongoing medical study?

"According to the details on clinicaltrials.gov, this trial is actively seeking participants. The study was initially posted on April 1st, 2024 and most recently revised on April 15th, 2024."

Answered by AI

Is the clinical trial open to individuals younger than 25 years of age?

"Patients eligible for this research must be between 18 and 65 years old. There are a total of 41 trials catering to participants below 18 years of age and 119 studies targeting individuals above the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

2024. "A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06323928.

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