Phase 2
Completed N=464
Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis
Source: ClinicalTrials.gov NCT01006265 ↗Enrolled (actual)
464
Serious AEs
4.8%
Results posted
Jun 2021
Primary outcomePrimary: Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24 — 1.4; 1.1; 3.5; 6.2 Lesions — p=<0.0001
Summary
This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24 |
1.4; 1.1; 3.5; 6.2 | <0.0001 sig |
| SECONDARY Annualized Confirmed Relapse Rate |
0.224; 0.396; 0.297; 0.601 | — |
| SECONDARY Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24 |
10; 17; 14; 25 | — |
Eligibility Criteria
Inclusion Criteria
- Adult males and females
- Diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for Multiple Sclerosis (MS).
- Signed inform consent prior to initiation of any study-mandated procedure.
Exclusion Criteria
- A diagnosis of MS categorized as primary progressive or secondary progressive or progressive relapsing.
- Patients currently treated for an autoimmune disorder other than MS.
- Contraindications for MRI.
- Ongoing bacterial, viral, or fungal infection.
- History or presence of malignancy.
Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.
Data sourced from ClinicalTrials.gov (NCT01006265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.