Medication Overuse Headache
Conditions
Keywords
Headache, Medication overuse, chronic, relapse
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.
Interventions
OTHERNo new specific intervention
No new specific intervention
Sponsors
Norwegian University of Science and Technology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Randomized during the initial trial during 2004-2006.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Headache Days/Month After 4 Years Compared to Baseline | Baseline and after 4 years | Change in headache days/month after 4 years compared to baseline |
Secondary
| Measure | Time frame |
|---|---|
| Change of Medication Days/Month Compared to Baseline | Baseline and after 4 years' of follow-up |
Countries
Norway
Participant flow
Recruitment details
Inclusion during the period between January 2008 and May 2010
Pre-assignment details
Invited to visit a neurologist, interviewed by telephone, give response by letter, or had headache data available in their hospital records
Participants by arm
| Arm | Count |
|---|---|
| Medication-overuse Headache Chronic daily headache combined with medication overuse | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Medication-overuse Headache |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Age, Continuous | 40.6 years STANDARD_DEVIATION 10.96 |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Change in Headache Days/Month After 4 Years Compared to Baseline
Change in headache days/month after 4 years compared to baseline
Time frame: Baseline and after 4 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication-overuse Headache | Change in Headache Days/Month After 4 Years Compared to Baseline | 6.6 headache days/month | Standard Deviation 9.87 |
Secondary
Change of Medication Days/Month Compared to Baseline
Time frame: Baseline and after 4 years' of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication-overuse Headache | Change of Medication Days/Month Compared to Baseline | 9.53 medication days/month | Standard Deviation 9.99 |