Medication-overuse Headache: 4 Years Follow up

NCT00918671 | Completed Results DMC

• 3 other identifiers: 4.2007.219207/447117429
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

From 1 January 2004 to 31 December 2006 64 individuals with probable medication overuse headache were included in a randomized, 1-year open-labeled, multicentre study to evaluate the effect of early introduction of prophylactic treatment compared to abrupt withdrawal and with a control group (ClinicalTrials.gov number NCT00159588). In this follow-up, randomized patients still alive 4 years after primary inclusion time will be invited to a follow up interview, evaluating the headache complaints and the proportion of recurrent medication overuse.

Conditions

Medication Overuse Headache

Keywords

Headache; Medication overuse; chronic; relapse

Outcome Measures

Primary Outcomes (1)

• Change in Headache Days/Month After 4 Years Compared to Baseline

  Change in headache days/month after 4 years compared to baseline

  Baseline and after 4 years

Secondary Outcomes (1)

• Change of Medication Days/Month Compared to Baseline

  Baseline and after 4 years' of follow-up

Study Arms (1)

Medication-overuse headache

Chronic daily headache combined with medication overuse

Other: No new specific intervention

Interventions

No new specific intervention OTHER

No new specific intervention

Medication-overuse headache

Eligibility Criteria

• Age: 22 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-70 years remitted to the out-patient clinics of the neuroloical departments of five University Hospitals in Norway with probable medication overuse headache included in a 1-year open-labeled trial during 2004-2006.

You may qualify if:

• Randomized during the initial trial during 2004-2006.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

Norwegian National headache Centre, NTNU

Trondheim, 7489, Norway

Location

Related Publications (3)

• 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 BACKGROUND

• Hagen K, Albretsen C, Vilming ST, Salvesen R, Gronning M, Helde G, Gravdahl G, Zwart JA, Stovner LJ. A 4-year follow-up of patients with medication-overuse headache previously included in a randomized multicentre study. J Headache Pain. 2011 Jun;12(3):315-22. doi: 10.1007/s10194-010-0285-1. Epub 2011 Jan 5.

  PMID: 21207237 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 Disorders, Secondary; Headache; Prescription Drug Overuse; Bronchiolitis Obliterans Syndrome; Recurrence

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Professor Knut Hagen
• Organization: NTNU

knut.hagen@ntnu.no

+4772575080

Study Officials

• Knut Hagen, MD, PhD

  Norwegian University of Science and Technology

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 11, 2009
• Study Start: January 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 2, 2020
• Results First Posted: December 30, 2010

Record last verified: 2020-11

Locations

NO (1)