About the Emerge Study:
This migraine study will test how a nasal powder works in people with acute migraine. You may be able to take part if you:
- Are 18-65 years of age
- Have at least a 1-year history of migraine
- Are willing to complete an e-diary (provided to you by study staff)
There are additional criteria that are reviewed by the study team at the study center at the first visit.
Please take a short survey here to see if you pre-qualify now!
If eligible, participation can last up to 3 months and require 3 visits to the study center. The study coordinator can answer any questions you have about this migraine study.
This migraine study will involve taking the study treatment (investigational treatment or placebo) after experiencing a moderate to severe migraine and completing the e-diary to document the effect of the study treatment on the migraine. The study will also involve visiting the study center 3 times, and completing study procedures, including documenting your experience in an e-diary (provided by the study staff).
This initial appointment is an opportunity for you to:
- Learn more about this migraine study. You’ll be speaking with a study coordinator at the study center to learn more regarding your participation in this migraine study.
- Ask any important questions you may have. These can be any questions you may have about this migraine study or clinical research in general.
- Determine if this migraine study may be right for you. After speaking with the study coordinator and learning details about this migraine study, the research staff will perform a series of screening tests to determine if you are eligible to participate. If you’re eligible, you will be given an opportunity to decide if participation is right for you. If you agree to take part, the center will ask you to review and sign a consent form.
The investigational treatment being studied is a powder, administered into the nose using a device that looks like the below image. If you are eligible and choose to participate in this study, you will be trained by study center staff on how to properly use the nasal device.
The study treatment is currently commercially available in other products as a subcutaneous (under the skin) injection, intramuscular (into the muscle) injection, intravenous (into the vein) injection, and as a nasal spray. This study is investigating how well this medication works as a nasal powder.
If you qualify for this migraine study, you will be randomly assigned to either the investigational treatment or a placebo (inactive substance). You have a 2-in-3 chance of receiving the investigational treatment, and a 1-in-3 chance of receiving a placebo. Neither you nor the study staff will know your assignment.
Do not discontinue any medication unless you are advised to do so by the study center staff or your primary care physician. The study center staff will discuss with you what you can do if your migraine persists after taking the study treatment.
The study centers are located in 29 states within the United States. This may change throughout the study, as study centers open and close.
There is no cost to you or your insurance provider for participating in the trial. If you qualify for this study, you may be reimbursed for your travel expenses.
No, health insurance is not needed in order to participate.
Research studies are designed in specific ways to test the investigational medication for safety and effectiveness. One or more of the answers that you provided were outside of the eligibility criteria for this trial. This does not mean you will not qualify for different research studies.
Migraine can cause severe pain, on one or both sides of the head. They can be accompanied by nausea, vomiting, and sensitivity to light/sound. Migraine can last for hours or days, and pain can be debilitating. For some people, migraine follows a specific pattern:
- Prodrome: Symptoms of prodrome usually begin a couple days prior to the migraine headache and can include constipation, mood changes, cravings, neck stiffness, increased thirst/urination, frequent yawning.
- Aura: Not all people who experience migraine have aura, in fact, most people don’t have these symptoms. Most commonly, aura presents as visual changes including flashes of light or wavy vision, but can also be sensation, movement, or verbal disturbances.
- Attack: Migraine typically lasts between 4 hours and 3 days. Pain is on one or both sides of the head and feels throbbing or pulsing. Having sensitivity to light and/or sound (sometimes smell and touch), as well as nausea/vomiting, blurred vision and feeling lightheaded are also symptoms of the attack phase of a migraine.
- Post-drome: This is the final phase of a migraine and occurs after the migraine attack for about 24 hours. Some people feel drained while others feel euphoric. Other symptoms of post-drome are confusion, moodiness, dizziness, weakness and sensitivity to light and sound.