A Phase IIIb, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability of EK-12 in Patients With RRMS
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Multiple Sclerosis - Relapsing Remitting
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will be randomized to one of the two treatment arms and will be observed during the treatment period of 144 weeksMasking: Single (Outcomes Assessor)Masking Description: A blinded examining neurologist/assessor will conduct neurological examinations, relapse and EDSS evaluations at each site. Treating investigators will not be blinded to the study treatment. Additionally, blinded evaluation of MRI scans will be performed at a central reading facility in which, anonymized and standardized images of patient with RRMS will be read by a treatment blinded assessor and data will be implemented in a post-hoc analysis for selected time-points.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT03283397
- Collaborators
- MonitorCRO
- Investigators
- Principal Investigator: Husnu Efendi, Prof Kocaeli University
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