Overview
Join this Migraine Clinical Research Study
This migraine clinical research study is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of an investigational treatment of patients with a acute migraine attack. Up to approximately 1,800 patients will be randomized in a 1:1:1 ratio to placebo or 10 or 20 mg of the treatment.
Randomization will be stratified according to use of background prophylactic medications for migraine (yes/no). Patients who meet all of the study entry criteria will be randomized and provided with study medication (placebo) to be taken on an outpatient basis as soon as they experience a moderate or severe (Grade 2 or 3) migraine headache.
About the Study
The investigational medication is a novel oral, potent, and highly selective blocker of transient receptor potential melastatin 8 (TRPM8) being developed for the acute treatment of migraine with or without aura in adults.
The migraine clinical research study is designed to evaluate the efficacy of the medication compared with placebo as measured by pain freedom at 2 hours post dose and as measured by freedom from the most bothersome migraine-associated symptom (MBS) at 2 hours post dose.
Specific objective of this migraine clinical research study:
To evaluate the efficacy of the investigational medication compared to placebo:
- on pain relief at 60 minutes post dose and 2 hours post-dose
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on sustained pain freedom from 2 to 48 hours post-dose
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on freedom from functional disability at 2 hours post dose
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on freedom from photophobia at 2 hours post dose
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on freedom from phonophobia at 2 hours post dose
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on freedom from nausea at 2 hours post dose
Who Can Join
Inclusion Criteria of this Migraine Clinical Research Study:
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Be a male or female, age 18 to 75 years
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Has greater than a one-year history of migraine with or without aura
“With aura” = you get a weird sensory warning before the migraine hits.
“Without aura” = the migraine comes on without those noticeable warning signals.
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Migraines typically last between 4 to 72 hours, if untreated.
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Has had >2 and ≤10 moderate or severe migraine attacks per month in each of the two months prior to screening.
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Females of reproductive potential must agree to remain abstinent or use an acceptable birth control method.
Exclusion Criteria:
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Has difficulty distinguishing his/her migraine attacks from tension-type headaches.
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Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than two hours.
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Has more than 15 headache-days per month.
- Is a female who is pregnant, breast-feeding or intends to become pregnant during the course of the study.
*Other conditions may apply
Not sure if you qualify?
A member of our study team will review your medical history and medications with you to determine if this migraine clinical research study may be a good fit.
You may also qualify for other studies.
What to Expect
Here’s what to expect when you participate in this migraine clinical research study:
Study Duration
The studied period for each participant is a single dose, with participation lasting up to 45 days. Patients will return to the study site within 5 to 8 days after treatment to allow review of the eDiary, assessment of medication compliance, and safety monitoring.
Number of Visits
Study Visit Schedule:
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Visit 1 (Screening): Conducted within -28 days to Visit 2 to determine eligibility.
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Visit 2 (Randomization): Occurs on Day 0 where patients are provided with study medication to be taken on an outpatient basis.
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Visit 3 (End of Study): Conducted 5 to 8 days after treating a qualifying migraine attack.
Procedures
Patients will use an electronic diary (eDiary) to record migraine-related information. Upon experiencing a potentially qualifying headache, subjects will log in and answer questions to ascertain whether the migraine headache is qualifying for treatment. During the 48 hours following the dose of study medication, patients will record various measures in the eDiary at specified time intervals, including pain severity and presence of migraine-associated symptoms.
If a patient has not experienced a qualifying migraine headache within 45 days after randomization, he or she will be withdrawn from the trial and instructed to return the unused study medication to the study center.
Compensation
Details regarding reimbursement for study-related expenses will be discussed with the clinical site staff during the screening process.
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 clinical research study.
