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

Migraine Clinical Trial

— MASTER  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01421277
• Other study ID #: 0974-076
• Status: Terminated
• Phase: N/A
• First received: July 28, 2011
• Last updated: October 1, 2015
• Start date: May 2011
• Est. completion date: March 2012

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 216
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Statin Therapy
Investigator's choice of any statin.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Main Reason for Stopping Triptan Use		Up to 3 months	No