Identifying Factors Underlying the Discontinuation of Tri... | NCT00890357

Studies
Identifying Factors Underlying the Discontinuation of Triptans

NCT00890357

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Mar 29, 2013Estimated

Enrollment

292Actual

Phase

Not provided

Conditions

Migraine
Medication Adherence

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Apr 27, 2009

First Submission Date that Met QC Criteria

Apr 27, 2009

First Posted Date

Apr 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2013

Last Update Posted Date

Mar 29, 2013Estimated

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to identify reasons migraine patients stop using triptan medications for abortive headache treatment. It is hypothesized that inadequate education of the patient at the time of prescribing the triptan is positively associated with triptan discontinuation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

292Actual

Eligibility Module

Eligibility Criteria

Triptan User Inclusion Criteria:

Episodic Migraine or Chronic Migraine
Have used a triptan medication in the prior 3 months
Have used triptan medications for at least 1 year

Triptan Discontinuation Inclusion Criteria:

Episodic Migraine or Chronic Migraine
Used any triptan medication in the last 2 years
Have not used a triptan medication in the last 6 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult Specialty Headache Clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Todd Schwedt, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of South Florida College of Medicine		Tampa	Florida	33612	United States
Washington University School of Medicine

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24001117	Derived	Wells RE, Markowitz SY, Baron EP, Hentz JG, Kalidas K, Mathew PG, Halker R, Dodick DW, Schwedt TJ. Identifying the factors underlying discontinuation of triptans. Headache. 2014 Feb;54(2):278-89. doi: 10.1111/head.12198. Epub 2013 Sep 3.

ID	Term
D008881	Migraine Disorders
D055118	Medication Adherence

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases