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Prophylactic Effect of Memantine in Chronic Tension-Type Headache

Primary Purpose

Tension-Type Headache

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
memantine
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension-Type Headache focused on measuring Chronic tension-type headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Chronic tension-type headache Normal urine pH Exclusion Criteria: More than 1 migraine attack/month Other major illnesses Overuse of medicine/alcohol Women not using AC Pregnant/breast-feeding women Allergy to memantine

Sites / Locations

  • Danish Headaches Center

Outcomes

Primary Outcome Measures

Headache duration
Headache intensity

Secondary Outcome Measures

Headache frequency
The use of simple analgesics
Side effects

Full Information

First Posted
April 18, 2006
Last Updated
February 19, 2009
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT00315666
Brief Title
Prophylactic Effect of Memantine in Chronic Tension-Type Headache
Official Title
Prophylactic Effect of Memantine in Chronic Tension-Type Headache
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Danish Headache Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to test whether memantine has a prophylactic effect on chronic tension-type headaches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache
Keywords
Chronic tension-type headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
memantine
Primary Outcome Measure Information:
Title
Headache duration
Title
Headache intensity
Secondary Outcome Measure Information:
Title
Headache frequency
Title
The use of simple analgesics
Title
Side effects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic tension-type headache Normal urine pH Exclusion Criteria: More than 1 migraine attack/month Other major illnesses Overuse of medicine/alcohol Women not using AC Pregnant/breast-feeding women Allergy to memantine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Bendtsen, MD, PhD
Organizational Affiliation
Danish Headaches Center, Dept. of Neurology, KAS Glostrup, DK-2600 Glostrup
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headaches Center
City
Glostrup
ZIP/Postal Code
DK-2600
Country
Denmark

12. IPD Sharing Statement

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Prophylactic Effect of Memantine in Chronic Tension-Type Headache

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