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

NCT00246337 | Completed Phase 2 Results

• 2 other identifiers: 0974-0042005_082
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Pain Freedom at 2 Hours

  2 hours post dose

• Sustained Pain Relief

  2-24 hours post dose

• Sustained Pain Freedom

  2-24 hours post dose

Study Arms (9)

Placebo

PLACEBO COMPARATOR

Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.

Drug: Comparator: Placebo

MK0974 25 mg

EXPERIMENTAL

MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Drug: MK0974

MK0974 50 mg

EXPERIMENTAL

MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Drug: MK0974

MK0974 100 mg

EXPERIMENTAL

MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Drug: MK0974

MK0974 200 mg

EXPERIMENTAL

MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Drug: MK0974

MK0974 300 mg

EXPERIMENTAL

MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Drug: MK0974

MK0974 400 mg

EXPERIMENTAL

MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Drug: MK0974

MK0974 600 mg

EXPERIMENTAL

MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Drug: MK0974

Rizatriptan 10 mg

ACTIVE COMPARATOR

Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Drug: Rizatriptan

Interventions

Comparator: Placebo DRUG

Placebo to match assigned treatment arm; one orally-administered dose

Placebo

MK0974 DRUG

MK0974 25 mg; one orally-administered dose

MK0974 25 mg

Rizatriptan DRUG

Rizatriptan 10 mg; one orally-administered dose

Rizatriptan 10 mg

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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. doi: 10.1212/01.WNL.0000286940.29755.61. Epub 2007 Oct 3.

  PMID: 17914062 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

telcagepant; rizatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Vice President of Late Stage Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@spcorp.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2005
• First Posted: October 31, 2005
• Study Start: November 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: November 2, 2015
• Results First Posted: September 15, 2010

Record last verified: 2015-10