NCT01657370

A Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-007)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the pharmacokinetics of MK-1602 in the treatment of acute migraine, including the influence of demographic and other variables on MK-1602 pharmacokinetics, and to evaluate the relationship between MK-1602 concentrations and efficacy of the drug.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	MK-1602	Three administrations of the same dose of MK-1602 on separate days. All 3 doses are either 1, 10, 25, 50 or 100 mg of MK-1602. Dose 1: Taken at onset of migraine of moderate or severe intensity. Dose 2: Taken the evening before Visit 2. Dose 3: Taken at Visit 2, which is Day 4 post migraine treatment (Dose 1). Dosage form is film coated tablet for oral administration.
DRUG	Placebo	Three administrations of placebo for MK-1602 on separate days. Dose 1: Taken at onset of migraine of moderate or severe intensity. Dose 2: Taken the evening before Visit 2. Dose 3: Taken at Visit 2, which is Day 4 post migraine treatment (Dose 1). Dosage form is film coated tablet for oral administration.
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, opiates or other medication not explicitly excluded.

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-11-01
• Completion: 2012-12-01
• First posted: 2012-08-06
• Last updated: 2016-12-09
• Results posted: 2016-12-09