Migraine Study

About Migraine

Migraine attacks are headaches of varying pain intensity often accompanied by nausea and sensitivity to light and sound. The SUMMIT Study is evaluating a new investigational medicine for the acute treatment of migraines.

Study Details

The SUMMIT study will last up to 3 months and will consist of 3 visits to the site. After establishing initial eligibility, the study participants will be able to use the investigational medicine (a powder administered into the nose) to potentially treat their next migraine attack.

Participants will also be asked to document the pain severity of their attacks, the presence of symptoms. And the impact on normal functioning over the 48-hour period after taking the investigational medicine.

The number of planned participants is approximately 1400 adult males and females aged 18 to 65 with acute migraine headaches.

Benefits of Participation

Taking part in a clinical study has numerous benefits such as:● Having access to investigate research treatments● Helping others by contributing to medical research

If you choose to participate you will receive all study-related medications and study-related care at no cost. Participants may be compensated up to $475 and health insurance is NOT needed.

Selected Inclusion Criteria

1. Has at least 1-year history of migraines (with or without aura).

2. Migraine headache frequency of 2 to 8 attacks of moderate or severe pain intensity per month in each of the 3 months prior to the Screening Visit

3. Fewer than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit.

4. Individual migraine attacks separated by at least 2 days of no headache pain.

5. Subject can distinguish migraines from other headache types, e.g., tension-type or cluster headache.

Selected Exclusion Criteria

1. Pregnant or breast-feeding women / women of child-bearing potential not using or not willing to use highly effective contraception.
2. Diagnosis of headache conditions other than migraine with or without aura, including diagnosis of basilar or hemiplegic migraines., medication overuse headache or cluster headache.
3. Abnormal physical findings of clinical significance which would interfere with the objectives of the study at the screening or randomization visit examination.
4. History of coronary artery disease & coronary artery vasospasm
5. History of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, and subarachnoid hemorrhage.