Medication-overuse HeadacheMUMNCT02903329
Comparison of Two Detoxification Protocols for Treatment of Medication-overuse Headache
A study testing Detoxification in people with Medication-overuse Headache, run by Danish Headache Center at 1 site in Denmark.
Trial summary
Medication-overuse headache (MOH) is a common, costly and disabling disorder affecting approximately 63 million people worldwide. MOH is a potentially treatable condition, and there are different opinions among headache specialists concerning the correct treatment strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication-overuse Headache
- What is being tested?
- Detoxification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MOH-diagnosis according to ICHD-3beta
- Eligible for out-patient care
- Previously diagnosed with primary headache forms.
Who cannot join
- Previously diagnosed with secondary headache forms
- Significant physical or psychiatric illness
- Pregnancy or breastfeeding
- Inadequate language skills to follow the patient education and filling out questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Restricted Acute Medication Intake Compared to no Acute Medication Intake During a Two Months Detoxification Period in Medication-overuse Headache
Medication-overuse headache (MOH) is a common, costly and disabling disorder affecting approximately 63 million people worldwide. MOH is a potentially treatable condition, and there are different opinions among headache specialists concerning the correct treatment strategy.
The study is a prospective longitudinal open-label randomized controlled study comparing two detoxification programs conducted in a tertiary headache care center. Patients with MOH are either randomized to treatment in program A or program B. In program A, patients undergo detoxification without any acute medication during a two months period (complete stop of acute medication intake). In program B, patients was allowed to take up to 2 days a week with analgesics or migraine medication during the two months detoxification period (restricted acute medication intake). Both A and B are out-patient programs, and patients in both groups receive patient education, consisting of six lessons, managed by specialized headache nurses in collaboration with specialized psychologists and physiotherapists (Figure 1). All patients are also offered rescue medication (levomepromazine or promethazine) and antiemetics, if necessary.
The need for prophylactic treatment is evaluated individually after 2-month detoxification. Patients are followed-up at 2, 6 and 12 months after detoxification. All patients are asked to continuously register headache calendar and to fulfill questionnaires at all the follow-up visits. In addition they are asked to fill out questionnaires (Headache Under-Response to Treatment (HURT), Hospital Anxiety and Depression Score (HADS), Severity of Dependence Score (SDS), World Health Organization Quality of Life Score(WHO QoL) and Dolo-score) at baseline, 2, 6 and 12 months
Read the detailed description
Patients with contact to Danish headache center are recruited consecutively. The MOH-diagnosis is based on least 3 months previous detailed history and at least 1 month fulfilled headache diary or headache calendar prior to the visit.
Patients were allocated to either program A or B by a concealed randomization process. The patients were randomized in blocks of 10 by use of opaque, sealed envelopes.
Statistics Statistical Package for Social Sciences (SPSS) version 22 is used for statistical calculations. Continuous variables are presented as mean (SD) and median (25-75 percentiles). For normal distributed continuous variables the investigators use paired and unpaired student's T-test, while for skewed distribution the investigators used Mann-Whitney test. Categorical variables is presented as percentage (N), and analyzed by chi-square test. All results are shown as intention-to-treat (ITT). The p-value is two-sided and p ≤ 0.05 is considered as significant.
The primary outcome is reduction in headache days per month. Clinical relevant difference is estimated to 20% between the two groups. The standard deviation based on previous published literature was estimated to 35%. Accepting an alfa-error on 5% and 80% power, 80 patients are needed. Based on previous studies, it is assumed that the drop-out rate will be approximately 15-20%. Therefore the investigators aim to include 100 patients corresponding to 50 in each group.
- Conditions
- Medication-overuse Headache
- Being tested
- Detoxification
- Medical subject headings
- Headache Disorders, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DetoxificationOther
Also called Treatment for MOH
Two ways of composing the detoxification protocol
| Study group | Role | What they receive |
|---|---|---|
| Protocol A | Active comparator | In program A, patients underwent detoxification without any acute medication during a two months period (complete stop of acute medication intake). Receives: Other: Detoxification |
| Protocol B | Active comparator | In program B, patients were allowed to take up to 2 days a week with analgesics or migraine medication during the two months detoxification period (restricted acute medication intake). Receives: Other: Detoxification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache frequency
Measured: 6 months
Secondary outcomes (8)
Days with acute medication/ month
Measured: 6 and 12 month
Headache frequency
Measured: 12 months
Headache intensity (Total intensity per month meassured by headache calendars).
Patients daily register headache intensity by 0,1, 2 or 3 corresponding to the intensity. The headache intensity is summed up for 30 days.
Measured: 6 and 12 months
Scores from questionnaires Headache Under-Response to Treatment (HURT)
Measured: 6 and 12 months
Scores from questionnaires Hospital Anxiety and Depression Score (HADS)
Measured: 6 and 12 months
Scores from questionnaires World Health Organization Quality of Life score
Measured: 6 and 12 months
Scores from questionnaires Severity of Dependence Score (SDS)
Measured: 6 and 12 months
Scores from questionnaires Dolo-score
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2013
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Carlsen, Danish Headache Center
- Investigators
- Louise Ninett Carlsen, MD, Study chair, Danich Headache Center, Neurological department, Rigshospitalet-Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903329
- Sponsor's protocol ID
- H-1-2012-116
- Acronym
- MUM
- Status last verified
- Jul 2018
- First submitted
- 1 Sep 2016
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nielsen M, Carlsen LN, Munksgaard SB, Engelstoft IMS, Jensen RH, Bendtsen L. Complete withdrawal is the most effective approach to reduce disability in patients with medication-overuse headache: A randomized controlled open-label trial. Cephalalgia. 2019 Jun;39(7):863-872. doi: 10.1177/0333102419828994. Epub 2019 Feb 7.
PubMed 30732459Carlsen LN, Munksgaard SB, Jensen RH, Bendtsen L. Complete detoxification is the most effective treatment of medication-overuse headache: A randomized controlled open-label trial. Cephalalgia. 2018 Feb;38(2):225-236. doi: 10.1177/0333102417737779. Epub 2017 Oct 19.
PubMed 29050498
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Restricted Acute Medication Intake Compared to no Acute Medication Intake During a Two Months Detoxification Period in Medication-overuse Headache
- ClinicalTrials.gov ID
- NCT02903329
- Acronym / sponsor ID
- MUM / H-1-2012-116
- Conditions
- Medication-overuse Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medication-overuse headache (MOH) is a common, costly and disabling disorder affecting approximately 63 million people worldwide. MOH is a potentially treatable condition, and there are different opinions among headache specialists concerning the correct treatment strategy.
The study is a prospective longitudinal open-label randomized controlled study comparing two detoxification programs conducted in a tertiary headache care center. Patients with MOH are either randomized to treatment in program A or program B. In program A, patients undergo detoxification without any acute medication during a two months period (complete stop of acute medication intake). In program B, patients was allowed to take up to 2 days a week with analgesics or migraine medication during the two months detoxification period (restricted acute medication intake). Both A and B are out-patient programs, and patients in both groups receive patient education, consisting of six lessons, managed by specialized headache nurses in collaboration with specialized psychologists and physiotherapists (Figure 1). All patients are also offered rescue medication (levomepromazine or promethazine) and antiemetics, if necessary.
The need for prophylactic treatment is evaluated individually after 2-month detoxification. Patients are followed-up at 2, 6 and 12 months after detoxification. All patients are asked to continuously register headache calendar and to fulfill questionnaires at all the follow-up visits. In addition they are asked to fill out questionnaires (Headache Under-Response to Treatment (HURT), Hospital Anxiety and Depression Score (HADS), Severity of Dependence Score (SDS), World Health Organization Quality of Life Score(WHO QoL) and Dolo-score) at baseline, 2, 6 and 12 months
Detailed description
Patients with contact to Danish headache center are recruited consecutively. The MOH-diagnosis is based on least 3 months previous detailed history and at least 1 month fulfilled headache diary or headache calendar prior to the visit.
Patients were allocated to either program A or B by a concealed randomization process. The patients were randomized in blocks of 10 by use of opaque, sealed envelopes.
Statistics Statistical Package for Social Sciences (SPSS) version 22 is used for statistical calculations. Continuous variables are presented as mean (SD) and median (25-75 percentiles). For normal distributed continuous variables the investigators use paired and unpaired student's T-test, while for skewed distribution the investigators used Mann-Whitney test. Categorical variables is presented as percentage (N), and analyzed by chi-square test. All results are shown as intention-to-treat (ITT). The p-value is two-sided and p ≤ 0.05 is considered as significant.
The primary outcome is reduction in headache days per month. Clinical relevant difference is estimated to 20% between the two groups. The standard deviation based on previous published literature was estimated to 35%. Accepting an alfa-error on 5% and 80% power, 80 patients are needed. Based on previous studies, it is assumed that the drop-out rate will be approximately 15-20%. Therefore the investigators aim to include 100 patients corresponding to 50 in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protocol A | Active comparator | Other: DetoxificationIn program A, patients underwent detoxification without any acute medication during a two months period (complete stop of acute medication intake). |
| Protocol B | Active comparator | Other: DetoxificationIn program B, patients were allowed to take up to 2 days a week with analgesics or migraine medication during the two months detoxification period (restricted acute medication intake). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MOH-diagnosis according to ICHD-3beta
- Eligible for out-patient care
- Previously diagnosed with primary headache forms.
Key exclusion criteria (4 listed)
- Previously diagnosed with secondary headache forms
- Significant physical or psychiatric illness
- Pregnancy or breastfeeding
- Inadequate language skills to follow the patient education and filling out questionnaires.
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 |
|---|---|---|
| DetoxificationAlso: Treatment for MOHTwo ways of composing the detoxification protocol | Other | Protocol A, Protocol B |
Primary outcome
Headache frequency
Time frame: 6 months
8 secondary outcomes
Days with acute medication/ month
Time frame: 6 and 12 month
Headache frequency
Time frame: 12 months
Headache intensity (Total intensity per month meassured by headache calendars).
Time frame: 6 and 12 months
Scores from questionnaires Headache Under-Response to Treatment (HURT)
Time frame: 6 and 12 months
Scores from questionnaires Hospital Anxiety and Depression Score (HADS)
Time frame: 6 and 12 months
Scores from questionnaires World Health Organization Quality of Life score
Time frame: 6 and 12 months
Scores from questionnaires Severity of Dependence Score (SDS)
Time frame: 6 and 12 months
Scores from questionnaires Dolo-score
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Derived from this study: PubMed 30732459Nielsen M, Carlsen LN, Munksgaard SB, Engelstoft IMS, Jensen RH, Bendtsen L. Complete withdrawal is the most effective approach to reduce disability in patients with medication-overuse headache: A randomized controlled open-label trial. Cephalalgia. 2019 Jun;39(7):863-872. doi: 10.1177/0333102419828994. Epub 2019 Feb 7.
- Derived from this study: PubMed 29050498Carlsen LN, Munksgaard SB, Jensen RH, Bendtsen L. Complete detoxification is the most effective treatment of medication-overuse headache: A randomized controlled open-label trial. Cephalalgia. 2018 Feb;38(2):225-236. doi: 10.1177/0333102417737779. Epub 2017 Oct 19.
- Individual participant dataSharing planned: No
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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.
Louise Ninett Carlsen, MD study chair
Danich Headache Center, Neurological department, Rigshospitalet-Glostrup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detoxification in people with Medication-overuse Headache, run by Danish Headache Center at 1 site in Denmark.
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 3 inclusion and 4 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 24 Jul 2018. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 frequency (time frame: 6 months). 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 NCT02903329, 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 24 Jul 2018.