The purpose of this study is to assess the effectiveness, safety and tolerability of a range of doses of MK-1602 versus placebo in the treatment of acute migraine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
834
Single 1, 10, 25, 50 or 100 mg dose of MK-1602 taken at onset of migraine of moderate or severe intensity. Dosage form is film coated tablet for oral administration. Dose is provided to participants as a blinded bottle of tablets packaged to achieve the various MK-1602 dose levels to be studied. Participants will be instructed to take all study medication from the bottle when they treat their migraine headache.
Single administration of placebo-matching MK-1602 taken at onset of migraine of moderate or severe intensity. Dosage form is film coated tablet for oral administration. Dose is provided to participants as a blinded bottle of tablets packaged to achieve placebo study medication. Participants will be instructed to take all study medication from the bottle when they treat their migraine headache.
Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose
PF was defined as a reduction in headache severity from Grade 2 or 3 at Baseline to Grade 0. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.
Time frame: 2 hours post-dose
Percentage of Participants Reporting Pain Relief (PR) at 2 Hours Post-Dose
PR was defined as a reduction of a moderate or severe migraine headache (Grade 2 or 3) at Baseline to a mild headache or no headache (Grade 1 or 0) 2 hours post-dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.
Time frame: 2 hours post-dose
Number of Participants With One or More Adverse Events Within 48 Hours Post-Dose
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product.
Time frame: Up to 48 hours post-dose
Number of Participants With One or More Adverse Events Within 14 Days Post-Dose
An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product.
Time frame: Up to 14 days post-dose
Number of Participants Who Discontinued From Study Due to Adverse Events
Time frame: Up to 5 weeks post-dose
Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
If moderate or severe migraine headache pain continues 2 hours after dose of study medication or if migraine headache comes back within 48 hours, Participants will be allowed to take their own rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs \[NSAIDs\]), anti-emetics, triptans or other medication not explicitly excluded.
Phonophobia is sensitivity to loud sounds.
Time frame: 2 hours post-dose
Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose
Photophobia is sensitivity to bright light.
Time frame: 2 hours post-dose
Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose
Time frame: 2 hours post-dose
Percentage of Participants Reporting Sustained Pain Freedom (SPF) 2-24 Hours Post-Dose
SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 24 hour period after dosing with study medication.
Time frame: 2-24 hours post-dose
Percentage of Participants Reporting SPF 2-48 Hours Post-Dose
SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 48 hour period after dosing with study medication.
Time frame: 2-48 hours post-dose
Percentage of Participants Reporting Sustained Pain Relief (SPR) 2-24 Hours Post-Dose
SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 24 hour period after dosing with study medication.
Time frame: 2-24 hours post-dose
Percentage of Participants Reporting SPR 2-48 Hours Post-Dose
SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 48 hour period after dosing with study medication.
Time frame: 2-48 hours post-dose
Percentage of Participants Reporting Total Migraine Freedom (TMF) at 2 Hours Post-Dose
TMF at 2 hours post dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose.
Time frame: 2 hours post-dose
Percentage of Participants Reporting TMF at 2-24 Hours Post-Dose
TMF at 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hour period after dosing with study medication.
Time frame: 2-24 hours post-dose
Percentage of Participants Reporting TMF at 2-48 Hours Post-Dose
TMF at 2-48 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 48 hour period after dosing with study medication.
Time frame: 2-48 hours post-dose