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Functional MRI (fMRI) in CGRP Induced Migraine
Plain-language guide to NCT00363532: not phased non-randomized trial of CGRP (Calcitonin Gene-Related Peptide), migraine, 12 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00363532
- Phase
- not phased
- Status
- completed
- Start
- 2006-09
- Completion (planned or actual)
- 2007-07
- Participants
- 12 (estimated)
- Design
- non-randomized, single-blind, treatment
- Conditions studied
- Migraine Without Aura
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested CGRP (Calcitonin Gene-Related Peptide) for migraine.
The patients will then be stimulated with noxious heat via a thermode placed at the forehead.
At the same time the Blood-oxygenation-level-dependent (BOLD) response will be measured via functional magnetic resonance imaging (fMRI), to estimate the central-nervous pain response.
The registry classes the interventions as drug.
Who Took Part
12 planned participants were the target.
It was open to people of any sex aged from 18 years up to 55 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients know with migraine without aura. No less then 1 migraine attach pr month and no more then 6 attaches per month. Weight 50-100 kg.
The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: daily use of medication other then birthcontrol pills; pregnant and lactation women; contraindications to mri-scans.
How the Study Was Run
It was run as a non-randomized, single-group and single-blind study.
In this single-blind CGRP (Calcitonin Gene-Related Peptide) study one party knew the assignments and the other did not.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2006-09 with completion listed for 2007-07.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Changes in BOLD response before and after CGRP infusion. Changes in BOLD response before and after injection of sumatriptan.
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of CGRP (Calcitonin Gene-Related Peptide) in 12 people with migraine.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the CGRP (Calcitonin Gene-Related Peptide) compound page, Migraine research.
Our Notes on the Compound
CGRP (Calcitonin Gene-Related Peptide): A 37-amino-acid neuropeptide that widens blood vessels and is involved in migraine; given in research provocation studies.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.