HeadacheNCT00159588
Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly?
A study testing Betablockers or other preventive drugs based on primary headache type in people with Headache, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
It is a common belief that patients with MOH rarely respond of preventative medications whilst overusing acute medications. However, no randomized trial has been done previously to prove such statement. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Headache
- What is being tested?
- Betablockers or other preventive drugs based on primary headache type
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2004to Dec 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fulfill 8.2.7 probably medication-overuse headache according to the International Classification of Headache Disorders, 2th Edition (2004)
Who cannot join
- No benefit of all available preventative medications
- no benefit of abrupt withdrawal lasting more than 3 weeks of acute medication that has been overused
- cluster headache
- chronic paroxysmal hemicrania
- hemicrania continua, pregnancy
- use of pain killers for other reasons than headache
- other reasons for chronic daily headache than medication-overuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly? A Randomized Multi-centre Follow-up.
It is a common belief that patients with MOH rarely respond of preventative medications whilst overusing acute medications. However, no randomized trial has been done previously to prove such statement. Based on some clinical experiences, our hypothesis are patients with probably MOH may benefit from use of preventive medications better than treatment with abrupt withdrawal or no specific treatment.
Read the detailed description
This randomized multi-centre study started January 2004, and patients with probably MOH have been included from five different University hospitals in Norway. The last patient was included November 9th 2006, final inclusion date was December 31th 2006. At this time a total of 64 patients with probable MOH according to the International Classification of Headache Disorders, 2nd Edition (2004) were included.
The included patients were randomized to one out of three possible options:
- Abrupt withdrawal of the acute medication(s) they have been overusing. After 3 month: use of preventative medication (best choice)in those who need such treatment, 12 month follow-up.
- Start with preventative medication (best choice) directly without abrupt withdrawal, 12 month follow-up.
- No specific treatment (controls), 5 month follow-up.
- Conditions
- Headache
- Being tested
- Betablockers or other preventive drugs based on primary headache type
- Keywords
- Medication-overuse headache, preventative medication, controls, follow-up, randomized, abrupt withdrawal
- Medical subject headings
- Headache, Headache Disorders, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betablockers or other preventive drugs based on primary headache typeDrug
Also called angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin
Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)
| Study group | Role | What they receive |
|---|---|---|
| Prophylaxis from the start | Active comparator | Use of preventive drugs from the start without abrupt withdrawal Receives: Drug: Betablockers or other preventive drugs based on primary headache type |
| Abrupt withdrawal | Other | Device: Abrupt withdrawal. Standard out-patients detoxication program including telephone call after 2 weeks and rescue medicine up to 2 days/week Receives: Drug: Betablockers or other preventive drugs based on primary headache type |
| Controls | Other | 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 Receives: Drug: Betablockers or other preventive drugs based on primary headache type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Days
Change in Headache days per month
Measured: 5 month
Secondary outcomes (1)
Headache Index
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
Measured: 5-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionNov 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Knut Hagen, MD; PhD,, Study chair, Dept. of Neurology, St. Olavs University Hospital, Trondheim, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159588
- Sponsor's protocol ID
- 2004/534
- Other IDs
- NCT00159588
- Status last verified
- Dec 2021
- First submitted
- 9 Sep 2005
- Last updated
- 11 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hagen K, Albretsen C, Vilming ST, Salvesen R, Gronning M, Helde G, Gravdahl G, Zwart JA, Stovner LJ. Management of medication overuse headache: 1-year randomized multicentre open-label trial. Cephalalgia. 2009 Feb;29(2):221-32. doi: 10.1111/j.1468-2982.2008.01711.x. Epub 2008 Sep 24.
PubMed 18823363Hagen K, Stovner LJ. A randomized controlled trial on medication-overuse headache: outcome after 1 and 4 years. Acta Neurol Scand Suppl. 2011;(191):38-43. doi: 10.1111/j.1600-0404.2011.01542.x.
PubMed 21711255
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly? A Randomized Multi-centre Follow-up.
- ClinicalTrials.gov ID
- NCT00159588
- Acronym / sponsor ID
- 2004/534
- Conditions
- Headache
- Keywords
- Medication-overuse headache, preventative medication, controls, follow-up, randomized, abrupt withdrawal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 1 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a common belief that patients with MOH rarely respond of preventative medications whilst overusing acute medications. However, no randomized trial has been done previously to prove such statement. Based on some clinical experiences, our hypothesis are patients with probably MOH may benefit from use of preventive medications better than treatment with abrupt withdrawal or no specific treatment.
Detailed description
This randomized multi-centre study started January 2004, and patients with probably MOH have been included from five different University hospitals in Norway. The last patient was included November 9th 2006, final inclusion date was December 31th 2006. At this time a total of 64 patients with probable MOH according to the International Classification of Headache Disorders, 2nd Edition (2004) were included.
The included patients were randomized to one out of three possible options:
- Abrupt withdrawal of the acute medication(s) they have been overusing. After 3 month: use of preventative medication (best choice)in those who need such treatment, 12 month follow-up.
- Start with preventative medication (best choice) directly without abrupt withdrawal, 12 month follow-up.
- No specific treatment (controls), 5 month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prophylaxis from the start | Active comparator | Drug: Betablockers or other preventive drugs based on primary headache typeUse of preventive drugs from the start without abrupt withdrawal |
| Abrupt withdrawal | Other | Drug: Betablockers or other preventive drugs based on primary headache typeDevice: Abrupt withdrawal. Standard out-patients detoxication program including telephone call after 2 weeks and rescue medicine up to 2 days/week |
| Controls | Other | Drug: Betablockers or other preventive drugs based on primary headache typeActive 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- fulfill 8.2.7 probably medication-overuse headache according to the International Classification of Headache Disorders, 2th Edition (2004)
Key exclusion criteria (7 listed)
- No benefit of all available preventative medications
- no benefit of abrupt withdrawal lasting more than 3 weeks of acute medication that has been overused
- cluster headache
- chronic paroxysmal hemicrania
- hemicrania continua, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betablockers or other preventive drugs based on primary headache typeAlso: angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentinSeveral preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin) | Drug | Abrupt withdrawal, Controls, Prophylaxis from the start |
Primary outcome
Headache Days
Time frame: 5 month
Change in Headache days per month
1 secondary outcome
Headache Index
Time frame: 5-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18823363Hagen K, Albretsen C, Vilming ST, Salvesen R, Gronning M, Helde G, Gravdahl G, Zwart JA, Stovner LJ. Management of medication overuse headache: 1-year randomized multicentre open-label trial. Cephalalgia. 2009 Feb;29(2):221-32. doi: 10.1111/j.1468-2982.2008.01711.x. Epub 2008 Sep 24.
- Results publication: PubMed 21711255Hagen K, Stovner LJ. A randomized controlled trial on medication-overuse headache: outcome after 1 and 4 years. Acta Neurol Scand Suppl. 2011;(191):38-43. doi: 10.1111/j.1600-0404.2011.01542.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knut Hagen, MD; PhD, study chair
Dept. of Neurology, St. Olavs University Hospital, Trondheim, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betablockers or other preventive drugs based on primary headache type in people with Headache, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Days (time frame: 5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00159588, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.