An interventional study of Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min) in Migraine Disorders, Migraine Without Aura and Headache Disorders, Primary, sponsored by Leiden University Medical Center. Completed. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-07.
Sponsored by Leiden University Medical Center · Not applicable, Interventional, and Basic science
To investigate the glutaminergic system in the onset of migraine-like attacks.
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.
109 studies on the registry are indexed under Migraine without Aura; 18 are open to participants now.
This study's enrollment of 39 is below the median of 87 across 87 interventional studies indexed under Migraine without Aura.
Browse Migraine without Aura studies →Leiden University Medical Center is the lead sponsor of 334 studies on the registry; 110 are open to participants now.
Compared within Migraine without Aura, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Migraine Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Glyceryl trinitrate (GTN)
Drug: Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)
Drug: Glyceryl trinitrate (GTN)
Drug: Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)
Drug page: Nitroglycerin
Glutamate
Changes in glutamate level
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
Glutamine
Changes in glutamine level
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
Changes in GABA level
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
Changes in N-acetylaspartate level
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
Changes in phosphoethanolamine level
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
Changes in myo-inositol level
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
Changes in glutathione level
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
Changes in aspartate level
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
Changes in creatine level
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
Changes in choline level
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2015 to primary completion in Apr 2016, 12 months.
Of 29 non-industry interventional studies with no phase under Migraine without Aura, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 34. This study's 12 months is below that.
Counting every sponsor, half of 33 studies reached it within 19 months; a quarter within 12 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nitroglycerin
Leiden University Medical Center →