Migraine DisordersNCT04220606
1H Magnetic Resonance Spectroscopy in Migraine Patients
A study testing Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min) in people with Migraine Disorders and Migraine Without Aura, run by Leiden University Medical Center.
Trial summary
To investigate the glutaminergic system in the onset of migraine-like attacks. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders, Migraine Without Aura, Headache Disorders, Primary
- What is being tested?
- Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2016
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosed with migraine without aura according to the International Classification of Headache Disorders (ICHD)-3 beta criteria from 2013.
- At least one migraine attack per month in the preceding six months
Who cannot join
- Other neurological disorders apart from migraine
- Chronic medication apart from oral contraceptives
- Migraine with aura
- Chronic migraine with 15 or more headache days per month/with 8 or more migraine days per month
- Medication-overuse headache (ICHD-3 beta criteria)
- Women who are breastfeeding, pregnant, or planning to become pregnant
Show all 9Show fewer
- Contra-indications for 7 tesla MRI scanner
- Contra-indications for GTN administration (e.g. nitrate allergy, heart condition)
- Healthy controls (with no first degree relative with migraine or trigeminal autonomic cephalalgia)
About this study
Official title: Glutamate Concentrations in the Brain Over the Course of a Migraine-like Attack
To investigate the glutaminergic system in the onset of migraine-like attacks.
Read the detailed description
Glyceryl trinitrate infusion (GTN) is used to provoke migraine-like attacks in female migraine without aura patients. Apart from migraine without aura patients healthy female controls are also included as a control group. Over the course of a single day these females (migraineurs and healthy controls) were scanned three times on fixed time slots: before GTN infusion (baseline), 90 minutes and 270 minutes after start of GTN infusion. Scans are acquired on a 7 tesla scanner (Philips, Cleveland, USA) on software release 3 using a 32 channel receive array using single-volume proton magnetic resonance spectroscopy (1H MRS) with a volume of interest in the visual cortex glutamate, in which glutamate, GABA and other metabolites will be assessed. The primary endpoint; glutamate level changes towards the pre-ictal and ictal state with other metabolite (e.g. glutamine and GABA) changes as secondary endpoints.
- Conditions
- Migraine Disorders, Migraine Without Aura, Headache Disorders, Primary, Headache Disorders, Brain Diseases, Central Nervous System Diseases
- Being tested
- Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)
- Medical subject headings
- Migraine Disorders, Migraine without Aura, Headache Disorders, Primary, Headache Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)Drug
| Study group | Role | What they receive |
|---|---|---|
| Migraine without aura subjects | Other | Drug: Glyceryl trinitrate (GTN) Receives: Drug: Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min) |
| Healthy subjects | Other | Drug: Glyceryl trinitrate (GTN) Receives: Drug: Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glutamate
Changes in glutamate level
Measured: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Secondary outcomes (9)
Glutamine
Changes in glutamine level
Measured: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
GABA
Changes in GABA level
Measured: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
N-acetylaspartate
Changes in N-acetylaspartate level
Measured: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Phosphoethanolamine
Changes in phosphoethanolamine level
Measured: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Myo-inositol
Changes in myo-inositol level
Measured: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Glutathione
Changes in glutathione level
Measured: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Aspartate
Changes in aspartate level
Measured: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Creatine
Changes in creatine level
Measured: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Choline
Changes in choline level
Measured: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study startApr 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research, European Commission
- Responsible party
- Principal investigator, G.M. Terwindt, MD, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220606
- Sponsor's protocol ID
- P07079.6
- Status last verified
- Jan 2020
- First submitted
- 30 Dec 2019
- Last updated
- 7 Jan 2020
- 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 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutamate Concentrations in the Brain Over the Course of a Migraine-like Attack
- ClinicalTrials.gov ID
- NCT04220606
- Acronym / sponsor ID
- P07079.6
- Conditions
- Migraine Disorders, Migraine Without Aura, Headache Disorders, Primary, Headache Disorders, Brain Diseases, Central Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research, European Commission
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 7 Jan 2020 (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.
To investigate the glutaminergic system in the onset of migraine-like attacks.
Detailed description
Glyceryl trinitrate infusion (GTN) is used to provoke migraine-like attacks in female migraine without aura patients. Apart from migraine without aura patients healthy female controls are also included as a control group. Over the course of a single day these females (migraineurs and healthy controls) were scanned three times on fixed time slots: before GTN infusion (baseline), 90 minutes and 270 minutes after start of GTN infusion. Scans are acquired on a 7 tesla scanner (Philips, Cleveland, USA) on software release 3 using a 32 channel receive array using single-volume proton magnetic resonance spectroscopy (1H MRS) with a volume of interest in the visual cortex glutamate, in which glutamate, GABA and other metabolites will be assessed. The primary endpoint; glutamate level changes towards the pre-ictal and ictal state with other metabolite (e.g. glutamine and GABA) changes as secondary endpoints.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraine without aura subjects | Other | Drug: Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)Drug: Glyceryl trinitrate (GTN) |
| Healthy subjects | Other | Drug: Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)Drug: Glyceryl trinitrate (GTN) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with migraine without aura according to the International Classification of Headache Disorders (ICHD)-3 beta criteria from 2013.
- At least one migraine attack per month in the preceding six months
Key exclusion criteria (9 listed)
- Other neurological disorders apart from migraine
- Chronic medication apart from oral contraceptives
- Migraine with aura
- Chronic migraine with 15 or more headache days per month/with 8 or more migraine days per month
- Medication-overuse headache (ICHD-3 beta criteria)
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 |
|---|---|---|
| Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min) | Drug | Healthy subjects, Migraine without aura subjects |
Primary outcome
Glutamate
Time frame: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Changes in glutamate level
9 secondary outcomes
Glutamine
Time frame: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
GABA
Time frame: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
N-acetylaspartate
Time frame: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Phosphoethanolamine
Time frame: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Myo-inositol
Time frame: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Glutathione
Time frame: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Aspartate
Time frame: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Creatine
Time frame: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
Choline
Time frame: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state
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 7 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Migraine Disorders
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
Questions about this trial
What is this clinical trial studying?
A study testing Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min) in people with Migraine Disorders and Migraine Without Aura, run by Leiden University Medical Center.
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 9 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 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Glutamate (time frame: From baseline towards the pre-ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) and ictal (assessed at 90 and/or 270 minutes after GTN depending on clinical condition) state). 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 7 Jan 2020.