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| ID | Type | Description | Link |
|---|---|---|---|
| NCT00159588 |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylaxis from the start | Active Comparator | Use of preventive drugs from the start without abrupt withdrawal |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betablockers or other preventive drugs based on primary headache type | Drug | Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin) |
| Measure | Description | Time Frame |
|---|---|---|
| Headache Days | Change in Headache days per month | 5 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Knut Hagen, MD; PhD, | Dept. of Neurology, St. Olavs University Hospital, Trondheim, Norway | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knut Hagen | Trondheim | 7006 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18823363 | Result | 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. | |
| 21711255 | Result | Hagen 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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64 randomized, 3 excluded not fulfilling the inclusion criteria after the baseline period
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| ID | Title | Description |
|---|---|---|
| FG000 | Preventive Drugs From the Start | Use of preventive drugs from the start without abrupt withdrawal. This group was not explicitly advised to withdraw overused medication. Preventive medication was started on day 1, based on a priority list of medicines (Betablockers, candesartan, topiramate, amitriptyline or other preventive relevant drugs. For each patient preventive agent was chosen on the basis of a list of specifications considering the primary headache, side-effects of the drug and what they have tried before. |
| FG001 | Abrupt Withdrawal | Device: Abrupt withdrawal |
| FG002 | Controls | Active control: No instruction for abrupt withdrawal or prophylactic treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5 Month Follow-up |
|
| ||||||||||||||||||
| 1-year Follow-up for Group 1 and 2 |
|
Three out of 64 randomized patients were excluded because they had <15 headache days/months at baseline. Baseline data was available in 61 who meet the inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Preventive Drugs From the Start | Preventive medication started day 1 without explicit advice of withdrawal of overused medication |
| BG001 | Abrupt Withdrawal | Standard out-patient detoxication program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Headache Days | Change in Headache days per month | Headache diary information available | Posted | Median | 95% Confidence Interval | days/month | 5 month |
|
5 months for controls, 1 year for the other two groups
Adverse events collected in the case report form (CRF) during consultation at 1, 3 and 5 months and during the 12-month follow up visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preventive Drugs From the Start | Use of preventive drugs from the start without abrupt withdrawal Betablockers or other preventive drugs: Several preventive drugs based on each individual |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | Ear and labyrinth disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Knut Hagen | St. Olavs Hospital | +47 95401579 | knut.hagen@stolav.no |
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| ID | Term |
|---|---|
| D006261 | Headache |
| D051271 | Headache Disorders, Secondary |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D057911 | Angiotensin Receptor Antagonists |
| D014635 | Valproic Acid |
| D000929 | Antidepressive Agents, Tricyclic |
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D010421 | Pentanoic Acids |
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|
| NOT COMPLETED |
|
| BG002 | Controls | Did not get a new preventive medication or direct advice to stop use of analgesics |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Controls | 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 Betablockers or other preventive drugs based on primary headache type: Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin) |
|
|
|
| Secondary | 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 | Headache diary information available | Posted | Mean | 95% Confidence Interval | headache index per month | 5-month follow-up |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 1 |
| 17 |
| EG001 | Abrupt Withdrawal | Device: Abrupt withdrawal | 0 | 20 | 0 | 20 | 3 | 20 |
| EG002 | Controls | Active control: No instruction for abrupt withdrawal or prophylactic treatment | 0 | 19 | 0 | 19 | 1 | 19 |
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| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000928 | Antidepressive Agents |
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000588 | Amines |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |