Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis

Actelion Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: ACT-128800 Dose 3; Drug: ACT-128800 Dose 2; Drug: Placebo; Drug: ACT-128800 Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01006265

AC-058B201

Details and patient eligibility

About

This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.

Enrollment: 464 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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464 participants in 4 patient groups, including a placebo group

ACT-128800 Dose 1

Experimental group

Description:

ACT-128800 Dose 1

Treatment:

Drug: ACT-128800 Dose 1

ACT-128800 Dose 2

Experimental group

Description:

ACT-128800 Dose 2

Treatment:

Drug: ACT-128800 Dose 2

ACT-128800 Dose 3

Experimental group

Description:

ACT-128800 Dose 3

Treatment:

Drug: ACT-128800 Dose 3

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo