Treatment of Medication-overuse Headache: 4 Years Follow up
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in Headache Days/Month After 4 Years Compared to Baseline
Study Overview
Brief Summary
From 1 January 2004 to 31 December 2006 64 individuals with probable medication overuse headache were included in a randomized, 1-year open-labeled, multicentre study to evaluate the effect of early introduction of prophylactic treatment compared to abrupt withdrawal and with a control group (ClinicalTrials.gov number NCT00159588). In this follow-up, randomized patients still alive 4 years after primary inclusion time will be invited to a follow up interview, evaluating the headache complaints and the proportion of recurrent medication overuse.
Detailed Description
The participants will be interviewed by telephone or consult the study doctor completing a headache diary for at least 1 month before attending the visit.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Randomized during the initial trial during 2004-2006.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Headache Days/Month After 4 Years Compared to Baseline
Time Frame: Baseline and after 4 years
Change in headache days/month after 4 years compared to baseline
Secondary Outcomes
- Change of Medication Days/Month Compared to Baseline(Baseline and after 4 years' of follow-up)