MigraineNCT04019496
Neurophysiology of Prophylactic Treatment in Migraine
An observational study of Migraine, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
This study aims to improve the pathophysiological understanding of migraine in in a longitudinal observational study investigating changes of established neurophysiological and imaging parameters in line with changes of the clinical phenotype. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- antibodies against calcitonin-gene related peptide or its receptor
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 29 Jan 2019to 2 May 2021
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients seen in the local headache clinic are screened for eligibility to participate the study. Clinical routine is not influenced by participation in this observational study, importantly choice of prophylactic treatment solely depends on the physician's and patient's decision based on national guidelines.
Who may be able to join
- episodic migraine according to ICHD (international classification of headache disorders)-3 criteria
- headache documented over at least 3 months through a headache calender
- scheduled for prophylactic therapy of their migraine
- not more than 3 years younger or older than matched control
- gender similar to matched control
- menstrual cycle equal to matched control (if female)
Who cannot join
- history of chronic migraine
- current medication-overuse headache
- neurological or psychiatric diagnosis other than headaches
- chronic intake of central nervous system active drugs (antidepressants, antipsychotics etc.)
- contraindications for magnetic resonance imaging
- contraindications for transcranial magnetic stimulation
- more than 1 headache day/month
- history of migraine
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology
Greifswald, Mecklenburg-Vorpommern, 17475
About this study
Official title: Neurophysiological Characterization of Treatment Response Following the Initiation of Prophylactic Therapy in Episodic Migraine
This study aims to improve the pathophysiological understanding of migraine in in a longitudinal observational study investigating changes of established neurophysiological and imaging parameters in line with changes of the clinical phenotype.
The study's focus is the investigation of mechanisms that are directly related to the cyclic character of migraine and its core structures. In this context, the primary endpoint is a change in the nociceptive blink reflex, an established brain stem reflex to study the trigemino-spinal system, associated with changes in migraine frequency and severity. In order to reliably detect changes in the trigeminal pain system, investigations are performed in patients before starting a prophylactic therapy and 3 months afterwards. Several secondary endpoints are used to evaluate changes of multimodal sensory and cortical information processing. Cerebral imaging will include examinations of structural and network effects of altered migraine disease activity.
- Conditions
- Migraine
- Being tested
- antibodies against calcitonin-gene related peptide or its receptor
- Keywords
- blink reflex, electroencephalography, functional magnetic resonance imaging, evoked potentials
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibodies against calcitonin-gene related peptide or its receptorDrug
the study is observational and does not interfere with clinical routine. In lin with this notion, the intervention is chosen by the treating physician in a shared decision making process involving the patient
| Study group | Role | What they receive |
|---|---|---|
| Episodic Migraine | Not described Receives: Drug: antibodies against calcitonin-gene related peptide or its receptor | |
| Healthy controls | equal to or less than 1 headache day/month |
What is being measured
The primary outcome is the main question the study is designed to answer.
nociceptive blink reflex habituation
habituation of the area under of the curve of the R2 blink reflex component on the side primarily affected by migraine headaches
Measured: baseline and after 3 months
Secondary outcomes (7)
nociceptive blink reflex area
area under of the curve of the R2 blink reflex component on the side primarily affected by migraine headaches
Measured: baseline and after 3 months
somatosensory evoked potentials (SSEP)
habituation of the N20 SSEP component following bilateral median nerve stimulation
Measured: baseline and after 3 months
pattern-reversal visual evoked potentials (VEP)
habituation of the P100 VEP component following bilateral optic nerve stimulation
Measured: baseline and after 3 months
migraine headache frequency
days with migraine headaches during the last month
Measured: baseline and after 3 months
headache impact test (HIT-6)
impact of migraine severity on daily routine
Measured: baseline and after 3 months
migraine disability assessment (MIDAS)
impact of migraine frequency on daily routine
Measured: baseline and after 3 months
Patient-Reported Outcomes Measurement Information System Profile 29 (PROMIS-29)
multi domain patient reported quality of life
Measured: baseline and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start29 Jan 2019
- Primary completion2 May 2021
- Study completion2 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019496
- Sponsor's protocol ID
- BB168/18
- Status last verified
- May 2021
- First submitted
- 10 Jul 2019
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thiele A, Klehr L, Strauss S, Angermaier A, Schminke U, Kronenbuerger M, Naegel S, Fleischmann R. Preventive treatment with CGRP monoclonal antibodies restores brain stem habituation deficits and excitability to painful stimuli in migraine: results from a prospective case-control study. J Headache Pain. 2021 Dec 11;22(1):149. doi: 10.1186/s10194-021-01364-x.
PubMed 34895133
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Characterization of Treatment Response Following the Initiation of Prophylactic Therapy in Episodic Migraine
- ClinicalTrials.gov ID
- NCT04019496
- Acronym / sponsor ID
- BB168/18
- Conditions
- Migraine
- Keywords
- blink reflex, electroencephalography, functional magnetic resonance imaging, evoked potentials
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 2 May 2021 (actual)
- Study completion
- 2 May 2021 (actual)
- First posted
- 15 Jul 2019 (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.
This study aims to improve the pathophysiological understanding of migraine in in a longitudinal observational study investigating changes of established neurophysiological and imaging parameters in line with changes of the clinical phenotype.
The study's focus is the investigation of mechanisms that are directly related to the cyclic character of migraine and its core structures. In this context, the primary endpoint is a change in the nociceptive blink reflex, an established brain stem reflex to study the trigemino-spinal system, associated with changes in migraine frequency and severity. In order to reliably detect changes in the trigeminal pain system, investigations are performed in patients before starting a prophylactic therapy and 3 months afterwards. Several secondary endpoints are used to evaluate changes of multimodal sensory and cortical information processing. Cerebral imaging will include examinations of structural and network effects of altered migraine disease activity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Episodic Migraine | – | Drug: antibodies against calcitonin-gene related peptide or its receptor |
| Healthy controls | – | –equal to or less than 1 headache day/month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients seen in the local headache clinic are screened for eligibility to participate the study. Clinical routine is not influenced by participation in this observational study, importantly choice of prophylactic treatment solely depends on the physician's and patient's decision based on national guidelines.
Key inclusion criteria (6 listed)
- episodic migraine according to ICHD (international classification of headache disorders)-3 criteria
- headache documented over at least 3 months through a headache calender
- scheduled for prophylactic therapy of their migraine
- not more than 3 years younger or older than matched control
- gender similar to matched control
Key exclusion criteria (8 listed)
- history of chronic migraine
- current medication-overuse headache
- neurological or psychiatric diagnosis other than headaches
- chronic intake of central nervous system active drugs (antidepressants, antipsychotics etc.)
- contraindications for magnetic resonance imaging
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 |
|---|---|---|
| antibodies against calcitonin-gene related peptide or its receptorthe study is observational and does not interfere with clinical routine. In lin with this notion, the intervention is chosen by the treating physician in a shared decision making process involving the patient | Drug | Episodic Migraine |
Primary outcome
nociceptive blink reflex habituation
Time frame: baseline and after 3 months
habituation of the area under of the curve of the R2 blink reflex component on the side primarily affected by migraine headaches
7 secondary outcomes
nociceptive blink reflex area
Time frame: baseline and after 3 months
somatosensory evoked potentials (SSEP)
Time frame: baseline and after 3 months
pattern-reversal visual evoked potentials (VEP)
Time frame: baseline and after 3 months
migraine headache frequency
Time frame: baseline and after 3 months
headache impact test (HIT-6)
Time frame: baseline and after 3 months
migraine disability assessment (MIDAS)
Time frame: baseline and after 3 months
Patient-Reported Outcomes Measurement Information System Profile 29 (PROMIS-29)
Time frame: baseline and after 3 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 27 May 2021.
- Derived from this study: PubMed 34895133Thiele A, Klehr L, Strauss S, Angermaier A, Schminke U, Kronenbuerger M, Naegel S, Fleischmann R. Preventive treatment with CGRP monoclonal antibodies restores brain stem habituation deficits and excitability to painful stimuli in migraine: results from a prospective case-control study. J Headache Pain. 2021 Dec 11;22(1):149. doi: 10.1186/s10194-021-01364-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by University Medicine Greifswald at 1 site in Germany.
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 6 inclusion and 8 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 27 May 2021. 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 Germany. 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?
nociceptive blink reflex habituation (time frame: baseline and after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04019496, which also lists 1 linked publication.
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 27 May 2021.