N/A
N=60
Medication-overuse Headache: 4 Years Follow up
Medication Overuse Headache
Bottom Line
View on ClinicalTrials.gov: NCT00918671 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcome: Primary: Change in Headache Days/Month After 4 Years Compared to Baseline — 6.6 headache days/month
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No new specific intervention (Other)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Norwegian University of Science and Technology
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Headache Days/Month After 4 Years Compared to Baseline |
6.6 | — |
| SECONDARY Change of Medication Days/Month Compared to Baseline |
9.53 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Randomized during the initial trial during 2004-2006.
Data sourced from ClinicalTrials.gov (NCT00918671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.