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fMRI with sensory stimulation

Phase 1

Functional Magnetic Resonance Imaging | Unknown | Other |Merck & Company, Inc.|Last Updated: Jun 10, 2016

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

fMRI with sensory stimulation · 1 trial · 1 indication

Phase 1 1
NCT01244282A Study of Two Methodologies for Measuring Blood Flow in the Brain in Response to Non-Drug Stimuli (P08085/MK-0000-180)Functional Magnetic Resonance Imaging
COMPLETED10 Analytics
PHASE1COMPLETED
A Study of Two Methodologies for Measuring Blood Flow in the Brain in Response to Non-Drug Stimuli (P08085/MK-0000-180)
Functional Magnetic Resonance ImagingUnlock trial analytics

Study Endpoints

Primary Endpoints

Magnitude of the MRI percent signal change in response to sensory stimulation without administration of ferumoxytol (BOLD fMRI)
45 minutes after initiation of imaging procedures
Magnitude of the MRI percent signal change in response to sensory stimulation following administration of the first dose of ferumoxytol (250 mg)
55 minutes after initiation of imaging procedures
Magnitude of the MRI percent signal change in response to sensory stimulation following administration of the second dose of ferumoxytol (100 mg, total cumulative dose of 350 mg)
70 minutes after initiation of imaging procedures
Magnitude of the MRI percent signal change in response to sensory stimulation following administration of the third dose of ferumoxytol (180 mg, total cumulative dose of 510 mg)
85 minutes after initiation of imaging procedures
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
All ParticipantsEXPERIMENTALfMRI studies with sensory stimulation in the presence of 0 mg, 250 mg, 350 mg, and 510 mg cumulative doses of ferumoxytol

Interventions

NameTypeDescription
fMRI with sensory stimulationPROCEDUREBOLD fMRI study with sensory stimulation followed by fMRI in the presence of increasing concentrations of ferumoxytol (Feraheme™)
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Eligibility Criteria

Age Range21 Years to 45 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Participant weighs approximately 55-75 kg and has a Body Mass Index (BMI) of 18-25 kg/m\^2 * Participant is in good health * Participant is a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 6 months Exclusion Criteria: * Participant has a ...

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Frequently asked questions about fMRI with sensory stimulation

What is fMRI with sensory stimulation used for?

fMRI with sensory stimulation is used for functional magnetic resonance imaging, a technique that measures blood flow in the brain in response to non-drug stimuli. It is an investigational methodology being studied for imaging applications, not a therapeutic treatment.

Who is developing fMRI with sensory stimulation?

fMRI with sensory stimulation is being developed by Merck & Company, Inc., traded on the New York Stock Exchange under the ticker MRK. The company conducted a Phase 1 study of this imaging methodology.

What phase is fMRI with sensory stimulation in?

fMRI with sensory stimulation is in Phase 1 clinical development. It is an investigational imaging methodology and has not been approved by the FDA. One Phase 1 trial has been completed.

What clinical trials is fMRI with sensory stimulation in?

fMRI with sensory stimulation was studied in one completed Phase 1 trial, NCT01244282, titled 'A Study of Two Methodologies for Measuring Blood Flow in the Brain in Response to Non-Drug Stimuli (P08085/MK-0000-180)'. The trial enrolled 10 healthy male volunteers aged 21 years and older.

Is fMRI with sensory stimulation the same as MK-0000-180?

Yes, fMRI with sensory stimulation is the same as MK-0000-180, as indicated by the trial title 'P08085/MK-0000-180'. The study evaluated two methodologies for measuring brain blood flow in response to non-drug stimuli.