A Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-006)

PHASE2CompletedINTERVENTIONAL
Enrollment

834

Participants

Timeline

Start Date

July 1, 2012

Primary Completion Date

December 1, 2012

Study Completion Date

December 1, 2012

Conditions
Migraine
Interventions
DRUG

MK-1602

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.

DRUG

Placebo-matching MK-1602

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.

DRUG

Rescue medication

"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."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Allergan

INDUSTRY