NCT01613248

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

A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 834 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Migraine

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-06-07
• Last updated: 2019-01-08
• Results posted: 2016-09-30