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Comparison of Two Detoxification Protocols for Treatment of Medication-overuse Headache (MUM)

This study is currently recruiting participants.
Verified February 2017 by Louise Carlsen, Danish Headache Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02903329
First Posted: September 16, 2016
Last Update Posted: February 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Louise Carlsen, Danish Headache Center
  Purpose

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


Condition Intervention
Medication-overuse Headache Other: Detoxification

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Restricted Acute Medication Intake Compared to no Acute Medication Intake During a Two Months Detoxification Period in Medication-overuse Headache

Resource links provided by NLM:


Further study details as provided by Louise Carlsen, Danish Headache Center:

Primary Outcome Measures:
  • Headache frequency [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]
    Patients daily register headache intensity by 0,1, 2 or 3 corresponding to the intensity. The headache intensity is summed up for 30 days.

  • 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 ]

Estimated Enrollment: 100
Study Start Date: September 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Protocol A
In program A, patients underwent detoxification without any acute medication during a two months period (complete stop of acute medication intake).
Other: Detoxification
Two ways of composing the detoxification protocol
Other Name: Treatment for MOH
Active Comparator: Protocol B
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).
Other: Detoxification
Two ways of composing the detoxification protocol
Other Name: Treatment for MOH

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MOH-diagnosis according to ICHD-3beta
  • Eligible for out-patient care
  • Previously diagnosed with primary headache forms.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02903329


Contacts
Contact: Louise Ninett Carlsen, MD +45 38633553 louise.ninett.carlsen@regionh.dk

Locations
Denmark
Danish Headache Center Recruiting
Glostrup, Copenhagen, Denmark, 2600
Contact: Louise Ninett Carlsen, Phd-student    +4538633553    louise.ninett.carlsen@regionh.dk   
Sponsors and Collaborators
Danish Headache Center
Investigators
Study Chair: Louise Ninett Carlsen, MD Danich Headache Center, Neurological department, Rigshospitalet-Glostrup
  More Information

Responsible Party: Louise Carlsen, MD; PhD-student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02903329     History of Changes
Other Study ID Numbers: H-1-2012-116
First Submitted: September 1, 2016
First Posted: September 16, 2016
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Headache
Headache Disorders, Secondary
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders
Brain Diseases
Central Nervous System Diseases