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

NCT01613248 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 834

Last updated 2019-01-08

Study results available
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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

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 & Collaborators

  • Allergan

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-01
Primary Completion
2012-12-01
Completion
2012-12-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01613248 on ClinicalTrials.gov