Trial Outcomes & Findings for Medication-overuse Headache: 4 Years Follow up (NCT NCT00918671)
NCT ID: NCT00918671
Last Updated: 2020-12-02
Results Overview
Change in headache days/month after 4 years compared to baseline
Recruitment status
COMPLETED
Target enrollment
60 participants
Primary outcome timeframe
Baseline and after 4 years
Results posted on
2020-12-02
Participant Flow
Inclusion during the period between January 2008 and May 2010
Invited to visit a neurologist, interviewed by telephone, give response by letter, or had headache data available in their hospital records
Participant milestones
| Measure |
Medication-overuse Headache
Chronic daily headache combined with medication overuse
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Medication-overuse Headache: 4 Years Follow up
Baseline characteristics by cohort
| Measure |
Medication-overuse Headache
n=60 Participants
Chronic daily headache combined with medication overuse
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 10.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and after 4 yearsChange in headache days/month after 4 years compared to baseline
Outcome measures
| Measure |
Medication-overuse Headache
n=60 Participants
Chronic daily headache combined with medication overuse
|
|---|---|
|
Change in Headache Days/Month After 4 Years Compared to Baseline
|
6.6 headache days/month
Standard Deviation 9.87
|
SECONDARY outcome
Timeframe: Baseline and after 4 years' of follow-upOutcome measures
| Measure |
Medication-overuse Headache
n=60 Participants
Chronic daily headache combined with medication overuse
|
|---|---|
|
Change of Medication Days/Month Compared to Baseline
|
9.53 medication days/month
Standard Deviation 9.99
|
Adverse Events
Medication-overuse Headache
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place