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Medication-overuse Headache: 4 Years Follow up

NCT ID: NCT00918671

Last Updated: 2020-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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The participants will be interviewed by telephone or consult the study doctor completing a headache diary for at least 1 month before attending the visit.

Conditions

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Medication Overuse Headache

Keywords

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Headache Medication overuse chronic relapse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Medication-overuse headache

Chronic daily headache combined with medication overuse

No new specific intervention

Intervention Type OTHER

No new specific intervention

Interventions

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No new specific intervention

No new specific intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Randomized during the initial trial during 2004-2006.
Minimum Eligible Age

22 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Knut Hagen, MD, PhD

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Locations

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Norwegian National headache Centre, NTNU

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 18823363 (View on PubMed)

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.

Reference Type RESULT
PMID: 21207237 (View on PubMed)

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.

Reference Type RESULT
PMID: 21711255 (View on PubMed)

Other Identifiers

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4.2007.2192

Identifier Type: -

Identifier Source: secondary_id

07/4471

Identifier Type: -

Identifier Source: secondary_id

17429

Identifier Type: -

Identifier Source: secondary_id

4.2007.2192

Identifier Type: -

Identifier Source: org_study_id