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

Migraine Clinical Trial

Official title:

A Phase III, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Oral MK0974 in the Acute Treatment of Migraine With or Without Aura

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432237
• Other study ID #: 0974-016
• Secondary ID: 2006_526
• Status: Completed
• Phase: Phase 3
• First received: February 5, 2007
• Last updated: June 8, 2015
• Start date: March 2007
• Est. completion date: December 2007

Study information

• Verified date: June 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 MK0974 compared to a placebo for acute migraine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1703
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Exclusion Criteria:

• 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

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:
• MK0974 50 mg

• MK0974 150 mg

• MK0974 300 mg

• Comparator: Placebo
MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose	Pain Freedom at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 24 hours after dosing with study medication.	2 to 24 hours postdose	No
Secondary	Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose	Pain Freedom and no migraine-associated symptoms at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache or migraine-associated symptom during the 24 hours after dosing with study medication.	2 to 24 hours postdose	No
Secondary	Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose	Pain Freedom and no migraine-associated symptoms at 2 hours postdose.	2 hours postdose	No