A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients
Abstract
The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.
Conditions: Multiple Sclerosis.
Primary outcome: Number of Participants Experiencing Adverse Events (AEs); Number of Participants Experiencing Serious Adverse Events (SAEs); Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation; Number of Participants Experiencing Adverse Events (AEs) Leading to Withdrawal; Number of Participants Experiencing Adverse Events (AEs) of Special Interest; Number of Participants With Abnormalities in Blood Absolute Lymphocyte Count (ALC); Number of Participants With Abnormalities in White Blood Cell Count (WBC); Number of Participants With Abnormalities in Blood Absolute Neutrophil Count (ANC); Number of Participants With Abnormalities in Specific Liver Function Tests; Number of Participants With Electrocardiogram (ECG) Result Abnormalities; Number of Participants With Clinically Relevant Abnormalities in Vital Signs; Number of Participants With Physical Examination Abnormalities; Number of Participants Self-Identifying Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS); Number of Participants With Changes in Suicidality From Last Day on Treatment Per the Columbia-Suicide Severity Rating Scale (C-SSRS); Change in Physician's Withdrawal Checklist (PWC-20) Total Score From Last Day on Treatment; Change in Hospital Anxiety and Depression Scale (HADS) Score From Last Day on Treatment;…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 2,494 participants or records.
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