Comparison of Two Detoxification Protocols for Treatment of Medication-overuse Headache

NCT02903329 | Completed

• 1 other identifier: H-1-2012-116
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Medication-overuse Headache

Outcome Measures

Primary Outcomes (1)

• Headache frequency

  6 months

Secondary Outcomes (8)

• Days with acute medication/ month

  6 and 12 month

• Headache frequency

  12 months

• Headache intensity (Total intensity per month meassured by headache calendars).

  6 and 12 months

• Scores from questionnaires Headache Under-Response to Treatment (HURT)

  6 and 12 months

• Scores from questionnaires Hospital Anxiety and Depression Score (HADS)

  6 and 12 months

Study Arms (2)

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).

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).

Other: Detoxification

Interventions

Detoxification OTHER

Two ways of composing the detoxification protocol

Also known as: Treatment for MOH

Protocol A; Protocol B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, Copenhagen, 2600, Denmark

Location

Related Publications (2)

• 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.

  PMID: 30732459 DERIVED

• Carlsen 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.

  PMID: 29050498 DERIVED

MeSH Terms

Conditions

Headache Disorders, Secondary

Interventions

Inactivation, Metabolic; Therapeutics

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biotransformation; Metabolism; Pharmacokinetics; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Officials

• Louise Ninett Carlsen, MD

  Danich Headache Center, Neurological department, Rigshospitalet-Glostrup

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; PhD-student

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 16, 2016
• Study Start: September 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)