NCT00315666

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2006

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 20, 2009

Status Verified

February 1, 2009

Enrollment Period

1.1 years

First QC Date

April 18, 2006

Last Update Submit

February 19, 2009

Conditions

Tension-Type Headache

Keywords

Chronic tension-type headache

Outcome Measures

Primary Outcomes (2)

  • Headache duration

  • Headache intensity

Secondary Outcomes (3)

  • Headache frequency

  • The use of simple analgesics

  • Side effects

Interventions

memantineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic tension-type headache
  • Normal urine pH

You may not qualify if:

  • More than 1 migraine attack/month
  • Other major illnesses
  • Overuse of medicine/alcohol
  • Women not using AC
  • Pregnant/breast-feeding women
  • Allergy to memantine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headaches Center

Glostrup Municipality, DK-2600, Denmark

Location

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Memantine

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Lars Bendtsen, MD, PhD

    Danish Headaches Center, Dept. of Neurology, KAS Glostrup, DK-2600 Glostrup

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 19, 2006

Study Start

May 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 20, 2009

Record last verified: 2009-02

Locations

DK(1)