MigraineTeIINCT05278325
Improved Treatment Course for Patients With Migraine and Tension-type Headache
A study testing Telephone intervention in people with Migraine and Tension-Type Headache, run by Danish Headache Center at 1 site in Denmark.
Trial summary
The purpose of the study is to improve treatment for newly referred patients with migraine and tension-type headache to the Danish Headache Center. All patients will recieve an electronic questionnaire just before the first visit concerning their current and previous history of headache and headache treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Tension-Type Headache
- What is being tested?
- Telephone intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2020to 5 Oct 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Migraine and/or tension-type headache
Who cannot join
- Other headache diagnoses, including cluster headache, medication overuse-headache, other secondary headaches, trigeminal neuralgia.
- Included in clinical trials at the DHC.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to improve treatment for newly referred patients with migraine and tension-type headache to the Danish Headache Center.
All patients will recieve an electronic questionnaire just before the first visit concerning their current and previous history of headache and headache treatment.
Half of them will enter a special telephone-intervention (TeII) program with two planned phone-calls after 8 and 16 weeks from first visit. The other half of patients will follow the normal follow-up program.
All patients will be seen by a headache specialist after 6 months and will be asked to fill in a follow-up electronic questionnaire.
- Conditions
- Migraine, Tension-Type Headache
- Being tested
- Telephone intervention
- Medical subject headings
- Migraine Disorders, Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone interventionOther
Two planned phone call between clinical controls
| Study group | Role | What they receive |
|---|---|---|
| Telephone Intervention | Experimental | Two planned phone call by health care professionals after 8 and 16 weeks adjusting acute and preventive treatment Receives: Other: Telephone intervention |
| Business as usual | No intervention | No planned phone calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in preventive headache medication
Difference in number of patients with change in preventive headache medication in the two groups
Measured: From baseline to six months
Change in acute headache medication
Difference in number of patients with change in acute headache medication in the two groups
Measured: From baseline to six months
Secondary outcomes (6)
Change in headache frequency
Difference in change of headache days per month between the two groups
Measured: From baseline to six months
Change in migraine frequency
Difference in change of migraine days per month between the two groups
Measured: From baseline to six months
Change in Headache Under response to Treatment (HURT-8) score
Difference in change in HURT-8 scale between the two groups
Measured: From baseline to six months
Change in Insomnia Severity Index (ISI) score
Difference in change in ISI score between the two groups
Measured: From baseline to six months
Change in Hospitality Anxiety Depression Scale (HADS) score
Difference in change in HADS between the two groups
Measured: From baseline to six months
Change in patient satisfaction score
Difference in change in patient satisfaction score (five questions focusing on treatment course) between the two groups
Measured: At six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 May 2020
- Primary completion1 Apr 2021
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Carlsen, Danish Headache Center
- Investigators
- Henrik W Schytz, Ass Prof, Study chair, Rigshospitalet-Glostrup, Afdeling for Hjerne- og Nervesygdomme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278325
- Sponsor's protocol ID
- H18008942
- Acronym
- TeII
- Status last verified
- Mar 2022
- First submitted
- 23 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Treatment Course for Patients With Migraine and Tension-type Headache
- ClinicalTrials.gov ID
- NCT05278325
- Acronym / sponsor ID
- TeII / H18008942
- Conditions
- Migraine, Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 14 Mar 2022 (actual)
- 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 the study is to improve treatment for newly referred patients with migraine and tension-type headache to the Danish Headache Center.
All patients will recieve an electronic questionnaire just before the first visit concerning their current and previous history of headache and headache treatment.
Half of them will enter a special telephone-intervention (TeII) program with two planned phone-calls after 8 and 16 weeks from first visit. The other half of patients will follow the normal follow-up program.
All patients will be seen by a headache specialist after 6 months and will be asked to fill in a follow-up electronic questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone Intervention | Experimental | Other: Telephone interventionTwo planned phone call by health care professionals after 8 and 16 weeks adjusting acute and preventive treatment |
| Business as usual | No intervention | –No planned phone calls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Migraine and/or tension-type headache
Key exclusion criteria (2 listed)
- Other headache diagnoses, including cluster headache, medication overuse-headache, other secondary headaches, trigeminal neuralgia.
- Included in clinical trials at the DHC.
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 |
|---|---|---|
| Telephone interventionTwo planned phone call between clinical controls | Other | Telephone Intervention |
Primary outcome
Change in preventive headache medication
Time frame: From baseline to six months
Difference in number of patients with change in preventive headache medication in the two groups
Change in acute headache medication
Time frame: From baseline to six months
Difference in number of patients with change in acute headache medication in the two groups
6 secondary outcomes
Change in headache frequency
Time frame: From baseline to six months
Change in migraine frequency
Time frame: From baseline to six months
Change in Headache Under response to Treatment (HURT-8) score
Time frame: From baseline to six months
Change in Insomnia Severity Index (ISI) score
Time frame: From baseline to six months
Change in Hospitality Anxiety Depression Scale (HADS) score
Time frame: From baseline to six months
Change in patient satisfaction score
Time frame: At six months
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 14 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Henrik W Schytz, Ass Prof study chair
Rigshospitalet-Glostrup, Afdeling for Hjerne- og Nervesygdomme
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone intervention in people with Migraine and 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 1 inclusion and 2 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 14 Mar 2022. 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.
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?
Change in preventive headache medication (time frame: From baseline to six months). 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 14 Mar 2022.