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

Terminated

• Conditions: Migraine
• Interventions: Drug: Statin Therapy

• Registration Number: NCT01421277
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

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 Timeline

• Study Start: 2011-05-19
• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-08-19
• Study First Posted: 2011-08-22
• Primary Completion: 2012-03-23
• Study Completion: 2012-03-23
• Results First Submitted: 2014-09-08
• Results First Submitted QC: 2014-09-08
• Results First Posted: 2014-09-15
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-26
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants Enrolled in Protocol Version (V)1.1	Statin Therapy	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.
Participants Enrolled in Protocol V2	Statin Therapy	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Using a Triptan for Migraine Attacks	Up to 3 months	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.
Number of Participants Continuing Triptan Therapy	Up to 3 monoths	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.
Main Reason for Stopping Triptan Use	Up to 3 months