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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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12 December 2020 |
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Main ID: |
NCT02797015 |
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Date of registration:
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26/05/2016 |
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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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Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS
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Scientific title:
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A Phase I, Multicenter, Randomized, 12-Week, Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics and Pharmacodynamics of RPC 1063 in Patients With Relapsing Multiple Sclerosis |
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Date of first enrolment:
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June 23, 2016 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02797015 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- MS, as diagnosed by the revised 2010 McDonald criteria
- Exhibits a relapsing clinical course consistent with RMS and history of brain MRI
lesions consistent with MS
- Expanded disability status scale (EDSS) score between 0 and 6.0
Key Exclusion Criteria:
- Primary progressive MS
- Clinically relevant cardiovascular conditions or other relevant diseases that could
impact the implementation or interpretation of the trial, or put the patient at risk
Age minimum:
18 Years
Age maximum:
55 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: RPC1063
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Primary Outcome(s)
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Area under the plasma concentration-time curve (AUC)
[Time Frame: Approximately 3 months]
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Maximum plasma concentration (Cmax)
[Time Frame: 24 hours after the last RPC1063 dose on Day 85]
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Secondary Outcome(s)
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EDSS (Expanded Disability Status Scale)
[Time Frame: Up to the last RPC1036 dose on Day 85]
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Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count
[Time Frame: Up to 28 days after the last RPC1063 dose]
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Adverse Events
[Time Frame: Up to 28 days after the last RPC1063 dose]
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Secondary ID(s)
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RPC01-1001
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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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