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

NCT01421277 | Terminated Results

• 1 other identifier: 0974-076
• Study Type: observational
• Target: 216
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Main Reason for Stopping Triptan Use

  Up to 3 months

Study Arms (2)

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

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

Interventions

Statin Therapy DRUG

Investigator's choice of any statin.

Participants Enrolled in Protocol V2; Participants Enrolled in Protocol Version (V)1.1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6327

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: August 22, 2011
• Study Start: May 19, 2011
• Primary Completion: March 23, 2012
• Study Completion: March 23, 2012
• Last Updated: June 20, 2017
• Results First Posted: September 15, 2014

Record last verified: 2017-05