Tension-Type HeadachePhase 3NCT00315666
Prophylactic Effect of Memantine in Chronic Tension-Type Headache
A Phase 3 study testing memantine in people with Tension-Type Headache, run by Danish Headache Center at 1 site in Denmark.
Trial summary
The purpose of this study is to test whether memantine has a prophylactic effect on chronic tension-type headaches. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- memantine
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- May 2006to Jun 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic tension-type headache
- Normal urine pH
Who cannot join
- More than 1 migraine attack/month
- Other major illnesses
- Overuse of medicine/alcohol
- Women not using AC
- Pregnant/breast-feeding women
- Allergy to memantine
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test whether memantine has a prophylactic effect on chronic tension-type headaches.
- Conditions
- Tension-Type Headache
- Being tested
- memantine
- Keywords
- Chronic tension-type headache
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
memantineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache duration
Headache intensity
Secondary outcomes (3)
Headache frequency
The use of simple analgesics
Side effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Investigators
- Lars Bendtsen, MD, PhD, Principal investigator, Danish Headaches Center, Dept. of Neurology, KAS Glostrup, DK-2600 Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315666
- Sponsor's protocol ID
- 2006-000060-82
- Other IDs
- KA-20060021
- Status last verified
- Feb 2009
- First submitted
- 18 Apr 2006
- Last updated
- 20 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Effect of Memantine in Chronic Tension-Type Headache
- ClinicalTrials.gov ID
- NCT00315666
- Acronym / sponsor ID
- 2006-000060-82
- Conditions
- Tension-Type Headache
- Keywords
- Chronic tension-type headache
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 19 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether memantine has a prophylactic effect on chronic tension-type headaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic tension-type headache
- Normal urine pH
Key exclusion criteria (6 listed)
- More than 1 migraine attack/month
- Other major illnesses
- Overuse of medicine/alcohol
- Women not using AC
- Pregnant/breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| memantine | Drug | – |
Primary outcome
Headache duration
Headache intensity
3 secondary outcomes
Headache frequency
The use of simple analgesics
Side effects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Bendtsen, MD, PhD principal investigator
Danish Headaches Center, Dept. of Neurology, KAS Glostrup, DK-2600 Glostrup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing memantine in people with Tension-Type Headache, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache duration. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2009.