Study of Treatment Used for Migraine Headaches (MK-0974-076) (MASTER)

Migraine Attack Study of Treatment, Efficacy and Resource Use (MASTER) - McKesson Substudy (MK-0974-076)

This study will describe the reasons for triptan utilization patterns (continuation and discontinuation) in triptan-naïve participants and assess the stability of treatment utilization patterns over time according to standard medical guidelines or clinical practice standards of the investigating physician.

Study Overview

• Status: Terminated
• Conditions: Migraine
• Intervention / Treatment: Drug: Statin Therapy

Detailed Description

After study start, the Protocol was amended to clarifiy that the first triptan prescription must have been received by the participant within a time window of 3 months (± 2 weeks) prior to the participant being identified by the Investigator, and could be enrolled into the study within 6 months of taking the prescribed triptan medication for the first time and that use of a sample triptan would not disqualify a participant as long as the sample was of the same triptan that was eventually prescribed.

• Study Type: Observational
• Enrollment (Actual): 216

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with physician-diagnosed migraine (with or without aura) who have had at least two, but not more than 8 moderate to severe migraines during the 30 days prior to screening. Participants must have received a triptan prescription 3 months (± 2 weeks) prior to being identified by the physician, must have been triptan-naïve prior to that initial prescription, and must have taken triptan medication at least once within 6 months prior to the date of informed consent for screening.

Description

Inclusion criteria:

• At least 18 years of age in the United States at the time of consent
• Physician-diagnosed migraine with or without aura
• At least two and up to a maximum of 8 moderate to severe migraine attacks during the 30 days prior to screening
• Initial triptan prescription 3 months (± 2 weeks) prior to being identified as eligible for this study, and triptan-naïve before that initial prescription
• Used triptan medication at least once within 6 months prior to the date of informed consent for screening
• Internet access and able to complete online surveys via electronic data entry

Exclusion criteria:

• Treated with triptans prior to this study
• In active litigation and compensation issues including disability dispute cases with a Government agency
• Participation in a clinical trial within the last 90 days

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants Enrolled in Protocol Version (V)1.1; Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.	Drug: Statin Therapy; Investigator's choice of any statin.
Participants Enrolled in Protocol V2; Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.	Drug: Statin Therapy; Investigator's choice of any statin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Using a Triptan for Migraine Attacks	Participants reported information online. For this measure, the number of participants who used at least one dose of any newly prescribed triptan for the first time in response to a migraine attack were counted.	Up to 3 months
Number of Participants Continuing Triptan Therapy	Participants reported information online. For this measure, the number of participants who continued to use a triptan after the first migraine attack were counted; switching from one triptan to another was considered continued use.	Up to 3 monoths
Main Reason for Stopping Triptan Use		Up to 3 months

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 19, 2011
• Primary Completion (ACTUAL): March 23, 2012
• Study Completion (ACTUAL): March 23, 2012

Study Registration Dates

• First Submitted: July 28, 2011
• First Submitted That Met QC Criteria: August 19, 2011
• First Posted (ESTIMATE): August 22, 2011

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2017
• Last Update Submitted That Met QC Criteria: May 26, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 0974-076

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis