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

NCT ID: NCT01421277

Last Updated: 2017-06-20

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 216 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-19
• Study Completion Date: 2012-03-23

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.

Conditions

Migraine

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Statin Therapy

Intervention Type: DRUG

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.

Statin Therapy

Intervention Type: DRUG

Investigator's choice of any statin.

Interventions

Statin Therapy

Investigator's choice of any statin.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

0974-076

Identifier Type: -

Identifier Source: org_study_id