Do you have several migraine days per month?
See if you may qualify.Find out if the PROCEED Trial for episodic and chronic migraine is right for you!
The PROCEED Trial is evaluating the effectiveness of an investigational trial drug for the prevention of migraine.
Participants in the trial will be randomized (as if by the toss of a coin) to receive the investigational trial drug or placebo, which looks like the investigational trial drug but contains no active ingredients.
You may be able to join the PROCEED Trial if:
- You are between 18 and 65 years of age
- You have a history of chronic or episodic migraine for at least 1 year
- You have tried 1-4 different migraine prevention medications in the past 10 years that did not help you
- Your migraine started before age 50
- You have 4 or more migraine days per month over the past 3 months
- You are willing to complete an electronic diary every day during the trial
Other eligibility requirements need to be met to join the PROCEED Trial. Please contact us for additional information.
Participation in the PROCEED Trial involves a total of 5 visits, 1 phone call and a safety follow-up visit at the end of the trial and includes the following:
- Screening: 4 weeks
- Treatment period: 12 weeks
- Follow-up: 8 weeks
Lundbeck is a Danish pharmaceutical company, committed for over 70 years to neuroscience. At Lundbeck, patients are at the heart of everything we do. Our expertise in brain health provides us with a strong foundation for discovering and developing new treatments in this crucial field. Lundbeck is looking at a new way to treat and prevent migraine as not all persons with migraine experience a good response to currently available medications or are able to take them.
Lu AG09222 is an investigational trial drug that is being developed to inhibit (slow or stop) the activity of a protein called pituitary adenylate cyclase-activating polypeptide, or PACAP for short. PACAP is made naturally in the body. It causes the blood vessels that deliver blood to the brain to widen, allowing more blood to flow through them. Researchers think that this process plays a role in the development of migraine.
Because Lu AG09222 was developed to inhibit PACAP, researchers hope that treatment with Lu AG09222 will help prevent migraine attacks from happening. Lu AG09222 is an investigational trial drug currently in clinical development and is not commercially available to patients.
REFERENCES TO INFORMATION ON PREVIOUS TRIAL:
https://www.trialsummaries.com/Study/StudyDetails?id=14975&tenant=MT_LUN_9011
nejmoa2314577_plain-language-summary.pdf
https://clinicaltrials.gov/study/NCT05133323?cond=Migraine&term=Lu%20AG09222&rank=4
Clinical trials (also called clinical research trials) are needed to find out whether an investigational trial drug is safe and works to treat a certain condition or a certain group of patients.
During a trial, researchers record information about the effects of the investigational trial drug being studied. Once the trial is completed, specially trained government officials carefully review the information. They then decide whether the investigational trial drug can or cannot be used by the public or if more research is needed.
Strict rules must be followed during clinical trials to help protect the rights, safety, and privacy of the people taking part. The rules also make sure the studies are done ethically and meet approved medical standards.
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Frequently asked questions
The PROCEED Trial is evaluating the effectiveness of an investigational trial drug for the prevention of migraine.
Taking part in the PROCEED Trial will last up to 24 Weeks and involve 6 visits to the clinical trial site and 1 phone call.
During the screening period, which will last 4 weeks, you will have tests and procedures to see if you are eligible to participate in the PROCEED Trial.
If you qualify, you will be randomly assigned (as if by the toss of a coin) to get either the investigational trial drug or placebo, which looks like the investigational trial drug but has no active ingredients.
Both the investigational trial drug or placebo will be given 3 times with 4 weeks between each treatment. A safety follow-up visit will take place 12 weeks after the last dose of the investigational trial drug (or placebo).
You will also complete an electronic diary every day during the trial and answer questions about your migraine symptoms and experience.
Joining the PROCEED Trial is completely up to you. Deciding not to take part will not affect your usual medical care now or in the future. If you take part, you can decide to leave the trial at any time and for any reason.
Financial reimbursement for trial-related travel and expenses may be available. For more information, please speak with a member of the trial team during your visits.
Participants have the possibility to help to advance scientific knowledge about preventing migraines and potentially contribute to helping others living with migraines.
Every clinical research trial must be reviewed, and is continually monitored, by a regulatory review committee to ensure the risks are as low as possible and are worth any potential benefits to the trial participant. If you are eligible for the trial and seek to participate, you will be informed of potential risks and how your data is handled during the trial consent process. As a trial participant, you have the right to discontinue your participation and leave the trial at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled to.
H. Lundbeck A/S is responsible for conducting this clinical research trial.
