Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)

NCT00432237 | Completed Phase 3 Results

• 2 other identifiers: 0974-0162006_526
• Study Type: interventional
• Target: 1,703
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a placebo for acute migraine.

Conditions

Migraine

Outcome Measures

Primary Outcomes (5)

• Number of Patients Reporting Pain Freedom at 2 Hours Postdose

  Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.

  2 hours post dose

• Number of Patients Reporting Pain Relief at 2 Hours Post Dose

  Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain.

  2 hours post dose

• Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose

  Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary.

  2 hours post dose

• Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose

  Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary.

  2 hours post dose

• Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose

  Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.

  2 hours post dose

Secondary Outcomes (3)

• Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose

  2 to 24 hours postdose

• Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose

  2 to 24 hours postdose

• Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose

  2 hours postdose

Study Arms (4)

MK0974 50 mg

EXPERIMENTAL

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

Drug: MK0974 50 mg

MK0974 150 mg

EXPERIMENTAL

MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack

Drug: MK0974 150 mg

MK0974 300 mg

EXPERIMENTAL

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

Drug: MK0974 300 mg

Placebo

PLACEBO COMPARATOR

Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack

Drug: Comparator: Placebo

Interventions

MK0974 50 mg DRUG

Also known as: MK0974

MK0974 50 mg

MK0974 150 mg DRUG

Also known as: MK0974

MK0974 150 mg

MK0974 300 mg DRUG

Also known as: MK0974

MK0974 300 mg

Comparator: Placebo DRUG

MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.

Placebo

Eligibility Criteria

• Age: 18 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

You may not qualify if:

• Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
• Patient has history or evidence of uncontrolled diabetes, or Human Immunodeficiency Virus (HIV) disease. Patient has uncontrolled cardiovascular disease
• Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than 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)

• Connor KM, Shapiro RE, Diener HC, Lucas S, Kost J, Fan X, Fei K, Assaid C, Lines C, Ho TW. Randomized, controlled trial of telcagepant for the acute treatment of migraine. Neurology. 2009 Sep 22;73(12):970-7. doi: 10.1212/WNL.0b013e3181b87942.

  PMID: 19770473 RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

telcagepant

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialDisclosure@merck.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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2007
• First Posted: February 7, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 3, 2015
• Results First Posted: December 6, 2010

Record last verified: 2015-06