Chronic migraine affects more than 1 billion people worldwide.1
A migraine attack can cause severe throbbing or pulsing sensation in the head that can last several hours, to several days. It can cause someone extreme pain and disability. The UNCHAINED Study is researching the effectiveness of an oral (taken by mouth) study drug that is being investigated to help improve or prevent migraine symptoms when combined with onabotulinumtoxinA (BOTOX®) injections. If you qualify and choose to participate you will have access to the study drug under investigation.
You may be eligible to participate if you:
- Are between the ages of 18-75 years old, inclusive
- Have a history of chronic migraine attacks for at least 1 year
- Currently receiving onabotulinumtoxinA (BOTOX®) injections as preventive medication for chronic migraine
- Experience 8 or more migraine days a month
* As a study patient, all study-related care will be provided at no cost to you. Compensation may be available for time and efforts.
Sign Up
What happens if I sign up? We will match you to a clinical research study location in your area that needs patients receiving onabotulinumtoxinA (BOTOX®) injections as preventive medication for chronic migraine or notify you when one becomes available. The study site will then contact you and you may have the opportunity to participate if qualified.
If you think you might like to participate in the UNCHAINED Study or would like more information, please enter your information below so we can see if you may qualify and can contact you about the studies. Keep in mind that participation is entirely voluntary. If you do decide to take part in a study, you may change your mind about participating at any time.
About Migraine
Migraine disease is a recurring type of headache. A migraine attack can cause severe throbbing pain or pulsing sensation in the head, usually only on one side, that lasts hours or even days.1,2 The pain may be associated with nausea, vomiting, and extreme light sensitivity.
Some people may experience a warning symptom known as an aura before or during a migraine attack.2 These typically last 5 minutes to an hour, causing symptoms such as:
- Vision loss
- Vision phenomena (seeing shapes, bright spots, or light flashes)
- Difficulty speaking
- Weakness or numbness
Although migraine disease is not fully understood, it appears that environment and genetics may play a role.1 Migraine pain is caused by faulty signals from the brain interacting with blood vessels and surrounding nerves.3
Many people who experience migraine attacks can identify their triggers and are able to steer clear of them.2 Common triggers can be:
- Hormonal changes
- Stress
- Caffeine
- Sleep changes
- Weather changes
- Food
- Medication
Some people can manage their symptoms by taking medication; however, many people continue to have regular and painful migraine attacks.
The UNCHAINED Study is researching the effectiveness of an oral (taken by mouth) study drug that is being investigated to help improve or prevent migraine symptoms when combined with onabotulinumtoxinA (BOTOX®) injections. If you qualify and choose to participate you will receive the oral investigational study drug and all study-related care at no cost.
Frequently Asked Questions
What is a research study?
A research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational drug – these may include how well an investigational study drug works for a certain condition. All prescription medications must be tested in clinical research studies before they can be approved and prescribed to patients.
Why are research studies important?
A research study is the process by which new and innovative medications, interventions and treatments are approved and brought to market. Even over-the-counter medications, such as NSAIDs, you may have used to counteract a headache, have gone through the clinical research study process before it was available at your local pharmacy.
What is the purpose of the UNCHAINED Study?
The UNCHAINED Study is researching the effectiveness of an oral (taken by mouth) study drug that is being investigated to help improve or prevent migraine symptoms when combined with onabotulinumtoxinA (BOTOX®) injections. If you qualify and choose to participate you will receive the oral investigational study drug and all study-related care at no cost.
What will the UNCHAINED Study involve?
The UNCHAINED Study will enroll about 75 patients who are currently receiving onabotulinumtoxinA (BOTOX®) injections as preventive medication for chronic migraine.
The overall participation will be approximately 32–40 weeks, which includes a 4 to 12-week screening period, a 24-week treatment period, and a 4-week follow up period. During the study, patients will be attending approximately 9 visits to the study center.
Will I receive compensation?
Patients may be compensated for their time and efforts. Please discuss this with the study site when they contact you.
Is there a cost to participate?
There is no cost to participate in the UNCHAINED Study. If you qualify, all study-related care will be provided at no cost to you.
What else do I need to consider?
The research team will be able to explain more about what the UNCHAINED Study will involve, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
How far is the study center?
We match you to a study center within a close travel distance from your home. If we are not running the study in your area currently, with your permission, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decided you no longer want your information stored, you can opt out and we will delete your information.
About the UNCHAINED Study
The UNCHAINED Study will enroll about 75 patients who are currently receiving onabotulinumtoxinA (BOTOX®) injections as preventive medication for chronic migraine.
The overall participation will be approximately 32–40 weeks, which includes a 4- to 12-week screening period, a 24-week treatment period, and a 4-week follow up period. Patients will be attending approximately 9 visits to the study center during the study.
Patients will receive all study-related care from a dedicated medical team at no cost.
Patients may be compensated for their time and efforts.
Who can take part in the UNCHAINED Study?
You may be eligible to participate if you:
- Are between the ages of 18-75 years old, inclusive
- Have a history of chronic migraine attacks for at least 1 year
- Currently receiving onabotulinumtoxinA (BOTOX®) injections as preventive medication for chronic migraine
- Experience 8 or more migraine days a month
The UNCHAINED Study is researching the effectiveness of an oral (taken by mouth) study drug that is being investigated to help improve or prevent migraine symptoms when combined with onabotulinumtoxinA (BOTOX®) injections. If you qualify and choose to participate you receive the oral investigational study drug and all study-related care at no cost.
