Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date July 28, 2011
First Posted Date August 22, 2011
Results First Submitted Date September 8, 2014
Results First Posted Date September 15, 2014
Last Update Posted Date June 20, 2017
Actual Study Start Date May 19, 2011
Actual Primary Completion Date March 23, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2014)
  • 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.
  • 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.
  • Main Reason for Stopping Triptan Use [ Time Frame: Up to 3 months ]
Original Primary Outcome Measures
 (submitted: August 19, 2011)
  • Number of participants on triptan therapy study entry [ Time Frame: At entry on study ]
  • Number of participants on triptan therapy at Month 3 [ Time Frame: Month 3 ]
Change History Complete list of historical versions of study NCT01421277 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Treatment Used for Migraine Headaches (MK-0974-076)
Official Title Migraine Attack Study of Treatment, Efficacy and Resource Use (MASTER) - McKesson Substudy (MK-0974-076)
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Migraine
Intervention Drug: Statin Therapy
Investigator's choice of any statin.
Study Groups/Cohorts
  • 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.
    Intervention: Drug: Statin Therapy
  • 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.
    Intervention: Drug: Statin Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: September 8, 2014)
216
Original Estimated Enrollment
 (submitted: August 19, 2011)
1000
Actual Study Completion Date March 23, 2012
Actual Primary Completion Date March 23, 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT01421277
Other Study ID Numbers 0974-076
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor Merck Sharp & Dohme Corp.
Collaborators Not Provided
Investigators Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2017