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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 August 2021 |
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Main ID: |
NCT04144257 |
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Date of registration:
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28/10/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Role of Microglial Activation and Norepinephrine Transporter Abnormalities in Pathogenesis of MS-related Fatigue
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Scientific title:
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Role of Microglial Activation and Norepinephrine Transporter Abnormalities in Pathogenesis of MS-related Fatigue |
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Date of first enrolment:
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March 12, 2020 |
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Target sample size:
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12 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04144257 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Tarun Singhal, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Brigham and Women's Hospital |
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Name:
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Steven Vaquerano |
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Address:
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Telephone:
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617-264-3044 |
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Email:
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svaquerano2@bwh.harvard.edu |
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Affiliation:
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Name:
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Tarun Singhal, MD |
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Address:
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Telephone:
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617-264-3043 |
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Email:
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tsinghal@bwh.harvard.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects meeting the definition for RRMS or SPMS by International Panel (2017
McDonald) Criteria.
- We will recruit patients with RRMS, recently diagnosed in the last 2 years. There will
be no disease modifying therapy restrictions for RRMS or SPMS patients.
- Male and female subjects age 18 to 60 years.
- Patients able to withhold medication that may interfere with C-11[MRB] radiotracer
uptake for 24 hours before the scan.
Exclusion Criteria:
- Relapse/Corticosteroid treatment in the past 4 weeks to avoid transient effects on
imaging
- Individuals with a known alternate neurologic disorder, previous head injury, or
substance abuse.
- Individuals with bipolar disease and schizophrenia
- Concurrent medical conditions that contraindicate study procedures.
- Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant
or suspects she is pregnant will be excluded from enrollment.
- Claustrophobia
- Non-MRI compatible implanted devices
- Low affinity binders
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: [F-18]PBR06
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Drug: [C-11]Methylreboxetine
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Primary Outcome(s)
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Standardized Uptake Value (SUV)/Standardized Uptake Value Ratio (SUVR)
[Time Frame: Baseline]
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Secondary Outcome(s)
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MRI global/regional volumetrics
[Time Frame: Baseline]
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Modified Fatigue Impact Scale (MFIS)
[Time Frame: Baseline]
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Binding Potential (BPnd)
[Time Frame: Baseline]
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Tissue Volume of distribution (Vt)/Distribution Volume Ratios (DVR)
[Time Frame: Baseline]
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MRI grey matter lesional load/brain atrophy
[Time Frame: Baseline]
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Secondary ID(s)
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2019P002356
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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