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

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ClinicalTrials.gov Identifier: NCT01421277
Recruitment Status : Terminated
First Posted : August 22, 2011
Results First Posted : September 15, 2014
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Migraine 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 Design

Study Type : Observational
Actual Enrollment : 216 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Migraine Attack Study of Treatment, Efficacy and Resource Use (MASTER) - McKesson Substudy (MK-0974-076)
Actual Study Start Date : May 19, 2011
Primary Completion Date : March 23, 2012
Study Completion Date : March 23, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants Using a Triptan for Migraine Attacks [ Time Frame: 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.

  2. Number of Participants Continuing Triptan Therapy [ Time Frame: 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.

  3. Main Reason for Stopping Triptan Use [ Time Frame: Up to 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01421277     History of Changes
Other Study ID Numbers: 0974-076
First Posted: August 22, 2011    Key Record Dates
Results First Posted: September 15, 2014
Last Update Posted: June 20, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases