A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)

Migraine Clinical Trial

Official title:

A Multicenter, Double-Blind, Placebo and Active-Controlled, Dose-Finding Study of MK0974 in the Treatment of Acute Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246337
• Other study ID #: 0974-004
• Secondary ID: 2005_082
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2005
• Last updated: October 30, 2015
• Start date: November 2005
• Est. completion date: May 2006

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy and safety of an MK 0974 for migraine headache and to identify an appropriate dose range for further study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient has at least 1 year history of migraine (with or without aura)

• Females of childbearing years must use acceptable contraception throughout trial

• Patient is in general good health based on screening assessment

Exclusion Criteria:

• Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)

• Patient has heart disease, uncontrolled hypertension (high blood pressure), uncontrolled diabetes or other significant disease

• Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other then migraine)

• Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption

• Patient has a history of cancer within the last 5 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Comparator: Placebo
Placebo to match assigned treatment arm; one orally-administered dose
• MK0974
MK0974 25 mg; one orally-administered dose
• MK0974
MK0974 50 mg; one orally-administered dose
• MK0974
MK0974 100 mg; one orally-administered dose
• MK0974
MK0974 200 mg; one orally-administered dose
• MK0974
MK0974 300 mg; one orally-administered dose
• MK0974
MK0974 400 mg; one orally-administered dose
• MK0974
MK0974 600 mg; one orally-administered dose
• Rizatriptan
Rizatriptan 10 mg; one orally-administered dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Ho TW, Mannix LK, Fan X, Assaid C, Furtek C, Jones CJ, Lines CR, Rapoport AM; MK-0974 Protocol 004 study group. Randomized controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine. Neurology. 2008 Apr 15;70(16):1304-12. Epub 2007 Oct 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Relief at 2 Hours	Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.	2 hours post dose	No
Secondary	Pain Freedom at 2 Hours	Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose.	2 hours post dose	No
Secondary	Sustained Pain Relief	Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.	2-24 hours post dose	No
Secondary	Sustained Pain Freedom	Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.	2-24 hours post dose	No