Medication Overuse HeadacheMOHfollowupNCT00918671
Medication-overuse Headache: 4 Years Follow up
An observational study of Medication Overuse Headache, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 74 years
- Conditions the study is for
- Medication Overuse Headache
- What is being tested?
- No new specific intervention
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2008to May 2010
- Phase
- Observational
- 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 22 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-70 years remitted to the out-patient clinics of the neuroloical departments of five University Hospitals in Norway with probable medication overuse headache included in a 1-year open-labeled trial during 2004-2006.
Who may be able to join
- Randomized during the initial trial during 2004-2006.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Medication-overuse Headache: 4 Years Follow up
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.
Read the 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.
- Conditions
- Medication Overuse Headache
- Being tested
- No new specific intervention
- Keywords
- Headache, Medication overuse, chronic, relapse
- Medical subject headings
- Headache Disorders, Secondary, Headache, Prescription Drug Overuse, Bronchiolitis Obliterans Syndrome, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No new specific interventionOther
No new specific intervention
| Study group | Role | What they receive |
|---|---|---|
| Medication-overuse headache | Chronic daily headache combined with medication overuse Receives: Other: No new specific intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Headache Days/Month After 4 Years Compared to Baseline
Change in headache days/month after 4 years compared to baseline
Measured: Baseline and after 4 years
Secondary outcomes (1)
Change of Medication Days/Month Compared to Baseline
Measured: Baseline and after 4 years' of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJan 2008
- Primary completionMay 2010
- Study completionMay 2010
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 (3)Papers the sponsor has linked to this study.
- Other trials for Medication Overuse HeadacheStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 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, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918671
- Sponsor's protocol ID
- 4.2007.2192
- Other IDs
- 4.2007.2192, 07/4471, 17429
- Acronym
- MOHfollowup
- Status last verified
- Nov 2020
- First submitted
- 9 Jun 2009
- Last updated
- 2 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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, Albretsen C, Vilming ST, Salvesen R, Gronning M, Helde G, Gravdahl G, Zwart JA, Stovner LJ. A 4-year follow-up of patients with medication-overuse headache previously included in a randomized multicentre study. J Headache Pain. 2011 Jun;12(3):315-22. doi: 10.1007/s10194-010-0285-1. Epub 2011 Jan 5.
PubMed 21207237Hagen 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 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Medication-overuse Headache: 4 Years Follow up
- ClinicalTrials.gov ID
- NCT00918671
- Acronym / sponsor ID
- MOHfollowup / 4.2007.2192
- Conditions
- Medication Overuse Headache
- Keywords
- Headache, Medication overuse, chronic, relapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Posted 30 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medication-overuse headache | – | Other: No new specific interventionChronic daily headache combined with medication overuse |
Who may qualify
- Ages
- 22 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-70 years remitted to the out-patient clinics of the neuroloical departments of five University Hospitals in Norway with probable medication overuse headache included in a 1-year open-labeled trial during 2004-2006.
Key inclusion criteria (1 listed)
- Randomized during the initial trial during 2004-2006.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| No new specific interventionNo new specific intervention | Other | Medication-overuse headache |
Primary outcome
Change in Headache Days/Month After 4 Years Compared to Baseline
Time frame: Baseline and after 4 years
Change in headache days/month after 4 years compared to baseline
1 secondary outcome
Change of Medication Days/Month Compared to Baseline
Time frame: Baseline and after 4 years' of follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: 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 21207237Hagen K, Albretsen C, Vilming ST, Salvesen R, Gronning M, Helde G, Gravdahl G, Zwart JA, Stovner LJ. A 4-year follow-up of patients with medication-overuse headache previously included in a randomized multicentre study. J Headache Pain. 2011 Jun;12(3):315-22. doi: 10.1007/s10194-010-0285-1. Epub 2011 Jan 5.
- 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
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Overuse 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 0 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 2 Dec 2020. 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 30 Dec 2010). 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?
Change in Headache Days/Month After 4 Years Compared to Baseline (time frame: Baseline and after 4 years). 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 NCT00918671, which also lists 3 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 2 Dec 2020; AzTrials last refreshed its copy on 30 Oct 2026.