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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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22 April 2024 |
Main ID: |
NCT02893111 |
Date of registration:
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27/08/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Efficacy and Safety of Bortezomib as add-on Treatment in Relapsing Neuromyelitis Optica Spectrum Disorder
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Scientific title:
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Single-center, Open Label Trial of Bortezomib as add-on Treatment in Relapsing Neuromyelitis Optica Spectrum Disorder |
Date of first enrolment:
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December 2015 |
Target sample size:
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5 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/ct2/show/NCT02893111 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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China
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age =18 years
- Diagnosis of NMOSD, as defined by 2015 criteria OR NMOSD seropositive spectrum
disorder (Recurrent ON or longitudinally extensive transverse myelitis (LETM)). All
patients must be NMO-IgG seropositive.
- Clinical evidence of at least 2 relapses in last 6 months or 3 relapses in the last 12
months (with at least 1 relapse occurring in the preceding 6 months)
- The B cell count must be normal (5-20% of total lymphocytes) in subjects before
administration of bortezomib
- Provision of written informed consent to participate in the study
- Corrected visual acuity 20/100 or better in at least one eye; otherwise, last attack
was myelitis and only attacks of myelitis are outcomes
- Ambulatory (with or without walker); otherwise, last attack was optic neuritis and
only attacks of optic neuritis are outcomes
Exclusion Criteria:
- Current evidence or known history of clinically significant infection (HSV, VZV, CMV,
EBV, HIV, Hepatitis viruses, Syphilis, etc)
- Pregnant, breastfeeding, or child-bearing potential during the course of the study
- Patients will not participate in any other clinical therapeutic study or will not have
participated in any other experimental treatment study within 30 days of screening
- Patients with a history of splenectomy, because of a potential increased risk of
developing meningococcal infection
- Participation in another interventional trial within the last 3 months
- Pre-existent sensory or motor polyneuropathy = degree 2 (NCI CTC AE criteria), within
14 days before screening
- Heart or kidney insufficiency
- Tumor disease currently or within last 5 years
- Clinically relevant liver, kidney or bone marrow function disorder
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Neuromyelitis Optica Spectrum Disorder
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Intervention(s)
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Drug: Bortezomib
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Primary Outcome(s)
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Annual relapse rate (ARR) of NMOSD Attacks
[Time Frame: Baseline, after 12 months of initial treatment]
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Secondary Outcome(s)
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Number of Subjects With Change in Visual Acuity in at Least One Eye by at Least One Point
[Time Frame: Baseline, 12 months]
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Retinal nerve fiber layer (RNFL)
[Time Frame: Baseline, 12 months]
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Change in Expanded Disability Status Scale (EDDS) Score
[Time Frame: Baseline, 12 months]
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Number of Participants with Adverse Events
[Time Frame: Baseline, 12 months]
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Cognition
[Time Frame: Baseline, 12 months]
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Timed 25-foot Walk
[Time Frame: Baseline, 12 months]
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MRI brain and spine
[Time Frame: Baseline, 12 months]
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Immunological assessments
[Time Frame: Baseline, 12 months]
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Secondary ID(s)
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IRB2016-YX-021
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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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