Chronic Migraine Epidemiology and Outcomes Study
This study is enrolling participants by invitation only.
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01648530
First received: July 20, 2012
Last updated: July 23, 2012
Last verified: July 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 20, 2012 | ||||
| Last Updated Date | July 23, 2012 | ||||
| Start Date ICMJE | July 2012 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Migraine Disability Assessment (MIDAS) [ Time Frame: 13 Months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01648530 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Subject Quality of Life Questionnaire [ Time Frame: 13 Months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Chronic Migraine Epidemiology and Outcomes Study | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | This is a population internet-based study to characterize migraine clinical course and impact on family. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Subjects with chronic migraine |
||||
| Condition ICMJE | Migraine Disorders | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Migraine
Subjects with migraine and household members |
||||
| 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 ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 15000 | ||||
| Estimated Completion Date | November 2013 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01648530 | ||||
| Other Study ID Numbers ICMJE | GMA-BTX-12-470 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Allergan | ||||
| Study Sponsor ICMJE | Allergan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Allergan | ||||
| Verification Date | July 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||