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

Merck Sharp & Dohme (MSD)

Status: Terminated

Conditions: Migraine

Treatments: Drug: Statin Therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT01421277

0974-076

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

216 participants in 2 patient groups

Participants Enrolled in Protocol Version (V)1.1

Description:

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.

Treatment:

Drug: Statin Therapy

Participants Enrolled in Protocol V2

Description:

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.

Treatment:

Drug: Statin Therapy