This Migraine clinical trial is testing the safety, tolerability and effectiveness of an investigational medication in comparison with a placebo in preventing migraines.
A placebo looks like the study treatment, but does not contain the active drug ingredient.
The investigational medication is a novel and natural nasal spray for preventative treatment of episodic migraine. Participants will be trained on the use of the nasal spray for in-home use following the first dose, which will be administered under the supervision of the study personnel. Daily self-assessments will be made in an e-diary during the 12 week treatment period and participants will be required to visit the site every 4 weeks during the treatment period and follow-up.
Eligible participants in the Breeze Study will receive study-related care and the investigational drug or placebo at no cost.
The study drug is an investigational product and you may or may not develop a benefit from the study drug. By participating in the Breeze Study, you may:
- Gain access to study-related care and medication at no cost to you
- Take an active role in your own healthcare
- Contribute to medical research and helping to shape the future of medicine
Migraine is a chronic, recurrent disorder that affects approximately 37 million Americans. Episodic migraine is characterized by up to 14 migraine days per month, while chronic migraine is 15 or more migraine headache days per month.
Symptoms may include:
- Pain on one side or both sides of your head
- Throbbing or pulsing pain
- Sensitivity to light, sounds, smells or touch
- Nausea and vomiting
- Blurred vision
Clinical Trial Frequently Asked Questions
What is a clinical trial?
A clinical trial is a research study that tests the safety and effectiveness of a new medicine or treatment in volunteers.
Every medical breakthrough goes through the clinical trial process.
Therefore, participants like you play a very important role in advancing medicine for present and future generations.
What is an investigational medication?
An investigational medication has been tested in the laboratory and the U.S. Food and Drug Administration (FDA) is allowing it to be tested in people.
It is not approved for sale by the FDA or other government agencies.
A clinical trial tests how well an investigational medication works and whether it is safe to use for a specific disease or disorder.
How does a clinical trial evaluating an investigational medication work?
A clinical trial has a structured set of clinic visits, tests, and drug dosing schedule the patient must follow.
Information about how you feel and how you are reacting to the study treatment is collected.
How are my rights and safety protected as a patient during a clinical trial?
Protecting the health and safety of people who take part in clinical trials is the highest priority for clinical researchers throughout the entire study process.
All clinical trials follow strict federal guidelines on how volunteers must be treated.
Can I leave the clinical trial before it ends?
You have the right to leave a clinical trial at any time, for any reason.
If you decide to leave a trial, talk to your doctor first.
You will want to know how leaving the trial might affect your health and what other treatment options may be available.
How can I learn more about the investigational medication and this study?
More information on this clinical trial can be found on clinicaltrials.gov.
Am I eligible for the Breeze Study?
To be eligible you must:
- Be between 18-65 years old
- Have at least a 1-year history of migraine
- Experience between 4-14 migraine days per month and 3-14 migraine attacks per month
- Able and willing to complete a daily migraine-history diary
- Additional study requirements will be discussed with a study representative.
If you are eligible and enroll in the Breeze Study, study-related care and treatment will be provided at no cost to you.