Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis

Phase 1

• Conditions: relapsing-remitting multiple sclerosis; MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis

• Registration Number: EUCTR2008-006786-92-FR
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-06
• Study Completion: 2011-06-17
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Adult males and females.
• Diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for Multiple Sclerosis (MS).
• Signed informed consent prior to initiation of any study mandated procedure.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients´ risk from participating in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To demonstrate the efficacy of at least one of three doses of ACT-128800 as compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS) on the cumulative number of new gadolinium-enhancing lesions per patient, recorded on four weekly T1 weighted MRI scans.;Secondary Objective: • To evaluate the effects of ACT-128800 on the annualized confirmed relapse rate.<br>• To evaluate the effects of ACT-128800 on time to first confirmed relapse.<br>• To evaluate the safety and tolerability of ACT-128800.<br>;Primary end point(s): • Cumulative number of new gadolinium-enhancing lesions per patient recorded on four weekly T1-weighted MRI scans.<br><br>