NCT04220606

Brief Summary

To investigate the glutaminergic system in the onset of migraine-like attacks.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

December 30, 2019

Last Update Submit

January 5, 2020

Conditions

Migraine DisordersMigraine Without AuraHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Outcome Measures

Primary Outcomes (1)

  • Glutamate

    Changes in glutamate level

    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

    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

    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

    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

    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

    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

  • +4 more secondary outcomes

Study Arms (2)

Migraine without aura subjects

OTHER

Drug: Glyceryl trinitrate (GTN)

Drug: Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)

Healthy subjects

OTHER

Drug: Glyceryl trinitrate (GTN)

Drug: Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)

Interventions

Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)DRUG
Healthy subjectsMigraine without aura subjects

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Migraine DisordersMigraine without AuraHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Interventions

Nitroglycerin

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 30, 2019

First Posted

January 7, 2020

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share