Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly?

NCT00159588 | Completed Results

• 2 other identifiers: 2004/534NCT00159588
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Headache

Keywords

Medication-overuse headache; preventative medication; controls; follow-up; randomized; abrupt withdrawal

Outcome Measures

Primary Outcomes (1)

• Headache Days

  Change in Headache days per month

  5 month

Secondary Outcomes (1)

• Headache Index

  5-month follow-up

Study Arms (3)

Prophylaxis from the start

ACTIVE COMPARATOR

Use of preventive drugs from the start without abrupt withdrawal

Drug: Betablockers or other preventive drugs based on primary headache type

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

Drug: Betablockers or other preventive drugs based on primary headache type

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

Drug: Betablockers or other preventive drugs based on primary headache type

Interventions

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)

Also known as: angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin

Abrupt withdrawal; Controls; Prophylaxis from the start

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fulfill 8.2.7 probably medication-overuse headache according to the International Classification of Headache Disorders, 2th Edition (2004)

You may not qualify if:

• No benefit of all available preventative medications
• no benefit of abrupt withdrawal lasting more than 3 weeks of acute medication that has been overused
• cluster headache
• chronic paroxysmal hemicrania
• hemicrania continua, pregnancy
• use of pain killers for other reasons than headache
• other reasons for chronic daily headache than medication-overuse

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

Knut Hagen

Trondheim, 7006, Norway

Location

Related Publications (2)

• 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.

  PMID: 18823363 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.

  PMID: 21711255 RESULT

MeSH Terms

Conditions

Headache; Headache Disorders, Secondary

Interventions

Angiotensin Receptor Antagonists; Valproic Acid; Antidepressive Agents, Tricyclic; Gabapentin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Antidepressive Agents; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Professor Knut Hagen
• Organization: St. Olavs Hospital

knut.hagen@stolav.no

+47 95401579

Study Officials

• Knut Hagen, MD; PhD,

  Dept. of Neurology, St. Olavs University Hospital, Trondheim, Norway

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 2004
• Primary Completion: November 1, 2006
• Study Completion: December 1, 2007
• Last Updated: March 11, 2022
• Results First Posted: December 1, 2021

Record last verified: 2021-12

Locations

NO (1)