Trial Outcomes & Findings for Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly? (NCT NCT00159588)
NCT ID: NCT00159588
Last Updated: 2022-03-11
Results Overview
Change in Headache days per month
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
5 month
Results posted on
2022-03-11
Participant Flow
64 randomized, 3 excluded not fulfilling the inclusion criteria after the baseline period
Participant milestones
| Measure |
Preventive Drugs From the Start
Use of preventive drugs from the start without abrupt withdrawal. This group was not explicitly advised to withdraw overused medication. Preventive medication was started on day 1, based on a priority list of medicines (Betablockers, candesartan, topiramate, amitriptyline or other preventive relevant drugs. For each patient preventive agent was chosen on the basis of a list of specifications considering the primary headache, side-effects of the drug and what they have tried before.
|
Abrupt Withdrawal
Device: Abrupt withdrawal
|
Controls
Active control: No instruction for abrupt withdrawal or prophylactic treatment
|
|---|---|---|---|
|
5 Month Follow-up
STARTED
|
19
|
22
|
20
|
|
5 Month Follow-up
COMPLETED
|
17
|
18
|
18
|
|
5 Month Follow-up
NOT COMPLETED
|
2
|
4
|
2
|
|
1-year Follow-up for Group 1 and 2
STARTED
|
17
|
18
|
18
|
|
1-year Follow-up for Group 1 and 2
COMPLETED
|
16
|
14
|
18
|
|
1-year Follow-up for Group 1 and 2
NOT COMPLETED
|
1
|
4
|
0
|
Reasons for withdrawal
| Measure |
Preventive Drugs From the Start
Use of preventive drugs from the start without abrupt withdrawal. This group was not explicitly advised to withdraw overused medication. Preventive medication was started on day 1, based on a priority list of medicines (Betablockers, candesartan, topiramate, amitriptyline or other preventive relevant drugs. For each patient preventive agent was chosen on the basis of a list of specifications considering the primary headache, side-effects of the drug and what they have tried before.
|
Abrupt Withdrawal
Device: Abrupt withdrawal
|
Controls
Active control: No instruction for abrupt withdrawal or prophylactic treatment
|
|---|---|---|---|
|
5 Month Follow-up
Withdrawal by Subject
|
2
|
4
|
2
|
Baseline Characteristics
Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly?
Baseline characteristics by cohort
| Measure |
Preventive Drugs From the Start
n=19 Participants
Preventive medication started day 1 without explicit advice of withdrawal of overused medication
|
Abrupt Withdrawal
n=22 Participants
Standard out-patient detoxication program
|
Controls
n=20 Participants
Did not get a new preventive medication or direct advice to stop use of analgesics
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 10 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 9 • n=7 Participants
|
38.7 years
STANDARD_DEVIATION 11 • n=5 Participants
|
40.9 years
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 5 monthPopulation: Headache diary information available
Change in Headache days per month
Outcome measures
| Measure |
Prophylaxis From the Start
n=17 Participants
Use of preventive drugs from the start without abrupt withdrawal
Betablockers or other preventive drugs based on primary headache type: Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)
|
Abrupt Withdrawal
n=18 Participants
Device: Abrupt withdrawal. Standard out-patients detoxication program including telephone call after 2 weeks and rescue medicine up to 2 days/week
Betablockers or other preventive drugs based on primary headache type: Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)
|
Controls
n=18 Participants
Active control: No instruction for abrupt withdrawal or prophylactic treatment. The controls finished the study period after 5 months observation, and were then offered the optimal type of treatment
Betablockers or other preventive drugs based on primary headache type: Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)
|
|---|---|---|---|
|
Headache Days
|
7.2 days/month
Interval 2.7 to 11.8
|
4.2 days/month
Interval 3.3 to 7.4
|
1.6 days/month
Interval 0.1 to 1.8
|
SECONDARY outcome
Timeframe: 5-month follow-upPopulation: Headache diary information available
Headache index (HI) per month calculated by the sum of products of headache days /month combined with mean daily hours with headache and mean daily headache severity on days with headache. High HI reflect high headache burden
Outcome measures
| Measure |
Prophylaxis From the Start
n=17 Participants
Use of preventive drugs from the start without abrupt withdrawal
Betablockers or other preventive drugs based on primary headache type: Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)
|
Abrupt Withdrawal
n=18 Participants
Device: Abrupt withdrawal. Standard out-patients detoxication program including telephone call after 2 weeks and rescue medicine up to 2 days/week
Betablockers or other preventive drugs based on primary headache type: Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)
|
Controls
n=18 Participants
Active control: No instruction for abrupt withdrawal or prophylactic treatment. The controls finished the study period after 5 months observation, and were then offered the optimal type of treatment
Betablockers or other preventive drugs based on primary headache type: Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)
|
|---|---|---|---|
|
Headache Index
|
169 headache index per month
Interval 89.0 to 248.0
|
371 headache index per month
Interval 296.0 to 513.0
|
302 headache index per month
Interval 252.0 to 424.0
|
Adverse Events
Preventive Drugs From the Start
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Abrupt Withdrawal
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Controls
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Preventive Drugs From the Start
n=17 participants at risk
Use of preventive drugs from the start without abrupt withdrawal
Betablockers or other preventive drugs: Several preventive drugs based on each individual
|
Abrupt Withdrawal
n=20 participants at risk
Device: Abrupt withdrawal
|
Controls
n=19 participants at risk
Active control: No instruction for abrupt withdrawal or prophylactic treatment
|
|---|---|---|---|
|
Ear and labyrinth disorders
dizziness
|
5.9%
1/17 • Number of events 1 • 5 months for controls, 1 year for the other two groups
Adverse events collected in the case report form (CRF) during consultation at 1, 3 and 5 months and during the 12-month follow up visit
|
15.0%
3/20 • Number of events 3 • 5 months for controls, 1 year for the other two groups
Adverse events collected in the case report form (CRF) during consultation at 1, 3 and 5 months and during the 12-month follow up visit
|
5.3%
1/19 • Number of events 1 • 5 months for controls, 1 year for the other two groups
Adverse events collected in the case report form (CRF) during consultation at 1, 3 and 5 months and during the 12-month follow up visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place