Overview
Migraine Medical Research Study:
The primary objective is to evaluate the safety and tolerability of intermittent use of an investigational medicine in the acute treatment of migraine. This is a safety study with no efficacy assessments.
Approximately up to 1,000 patients will be enrolled in this migraine medical research study. All patients will receive the investigational medicine, but the study will be double-blind with respect to dose, with participants randomized to receive either 10 mg or 20 mg of the product. Randomization will be stratified by use of preventative medications (yes/no).
About the Study
This migraine medical research study is a Phase 3 trial to evaluate the long-term safety of intermittent chronic dosing with an investigational medicine in patients with migraine attacks. Patients will be enrolled for up to 12 months and encouraged to treat all qualifying migraine attacks with the medicine.
All patients will be instructed to treat each migraine attack of any severity with the study drug as the first anti-migraine therapy. Patients will be instructed not to take more than 1 dose within a 24-hour period. Patients still experiencing pain or migraine-associated symptoms 2 hours after taking it may take any non-prohibited anti-migraine medication as rescue medication.
Who Can Join
Inclusion Criteria of this Migraine Medical Research Study:
- Patient is completing an acute treatment trial of a previous related study
- treated a qualifying migraine in that study
- was at least 80% compliant with the daily eDiary “check ins” in the base study
- and completed the 2-hour and 4-hour post dose assessments in the eDiary
- For females of reproductive potential (as determined in the base study), continues to agree to remain abstinent from heterosexual activity or agrees to use (or have their partner use) an acceptable birth control method.
Exclusion Criteria:
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Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study.
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Has, at the time of the base study had any change in medical history or a laboratory finding since screening in the acute treatment study
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Patient is at imminent risk of self-harm or of harm to others
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Patients report suicidal ideation with intent, with or without a plan
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Is currently in violation of study requirements for prohibited and permissible concomitant medications.
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Has any major surgery scheduled for the duration of the trial.
*Other conditions may apply
Note:
If you are still interested in this migraine medical research study but was not part of the previous base study, feel free to sign up below. A member of our study team will review your medical history and medications with you to determine if you may be a good fit for other migraine studies.
What to Expect
Here’s what to expect when you participate in this migraine medical research study:
Study Duration
The treatment period will be up to approximately 12 months for a patient.
Number of Visits
Study Visit Schedule:
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Visit 1 (Randomization)
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Visit 2 (Phone Call): Occurs 1 week after randomization
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Clinic Visits: Patients will return for clinic visits at Months 1, 3, 6, 9, and 12 (end of study).
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Phone Contacts: Scheduled phone contacts for collection will occur at weeks 4, 8, 17, 22, 32, and 45.
- Follow-Up: A follow-up phone call will occur at Week 52 (Day 365)
Procedures
An eDiary will be used for patients to record occurrence of migraines treated. Patients will also record occurrence of all migraine attacks and use of rescue medication.
Patients not treating at least 3 migraines by the 3-month visit will be discontinued as they are not likely to contribute meaningfully to the long-term safety profile.
Compensation
Participants should discuss any available reimbursement for study-related time and travel with the study site staff.
Need More Details?
The study team will explain all procedures, site visits, and other requirements in detail before you decide to participate in this migraine medical research study.
