MOHfollowup: Medication-overuse Headache: 4 Years Follow up

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00918671
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 28
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medication Overuse Headache	Other: No new specific intervention

Detailed Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Treatment of Medication-overuse Headache: 4 Years Follow up
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Medication-overuse headache Chronic daily headache combined with medication overuse	Other: No new specific intervention; No new specific intervention

Outcome Measures

Primary Outcome Measures

1. Change in Headache Days/Month After 4 Years Compared to Baseline [Baseline and after 4 years]

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

Secondary Outcome Measures

1. Change of Medication Days/Month Compared to Baseline [Baseline and after 4 years' of follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Randomized during the initial trial during 2004-2006.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Norwegian National headache Centre, NTNU	Trondheim		Norway	7489

Sponsors and Collaborators

• Norwegian University of Science and Technology

Investigators

• Study Chair: Knut Hagen, MD, PhD, Norwegian University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hagen K, Albretsen C, Vilming ST, Salvesen R, Grønning 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.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT00918671
• Other Study ID Numbers: 4.2007.2192; 4.2007.2192; 07/4471; 17429
• First Posted: Jun 11, 2009
• Last Update Posted: Dec 2, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by Norwegian University of Science and Technology: Headache; Medication overuse; chronic; relapse
• Additional relevant MeSH terms: Headache Disorders, Secondary; Headache

Study Results

Participant Flow

Recruitment Details	Inclusion during the period between January 2008 and May 2010
Pre-assignment Detail	Invited to visit a neurologist, interviewed by telephone, give response by letter, or had headache data available in their hospital records

Arm/Group Title	Medication-overuse Headache
Arm/Group Description	Chronic daily headache combined with medication overuse
Period Title: Overall Study
STARTED	60
COMPLETED	60
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Medication-overuse Headache
Arm/Group Description	Chronic daily headache combined with medication overuse
Overall Participants	60
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	60 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.6 (10.96)
Sex: Female, Male (Count of Participants)
Female	37 61.7%
Male	23 38.3%

Outcome Measures

1. Primary Outcome

Title	Change in Headache Days/Month After 4 Years Compared to Baseline
Description	Change in headache days/month after 4 years compared to baseline
Time Frame	Baseline and after 4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medication-overuse Headache
Arm/Group Description	Chronic daily headache combined with medication overuse
Measure Participants	60
Mean (Standard Deviation) [headache days/month]	6.6 (9.87)

2. Secondary Outcome

Title	Change of Medication Days/Month Compared to Baseline
Time Frame	Baseline and after 4 years' of follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medication-overuse Headache
Arm/Group Description	Chronic daily headache combined with medication overuse
Measure Participants	60
Mean (Standard Deviation) [medication days/month]	9.53 (9.99)

Adverse Events

Arm/Group Title	Medication-overuse Headache
Arm/Group Description	Chronic daily headache combined with medication overuse
All Cause Mortality
	Medication-overuse Headache
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Medication-overuse Headache
	Affected / at Risk (%)	# Events
Total	0/60 (0%)
Other (Not Including Serious) Adverse Events
	Medication-overuse Headache
	Affected / at Risk (%)	# Events
Total	0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.