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

This study has been completed.
Information provided by (Responsible Party):
Actelion Identifier:
First received: October 30, 2009
Last updated: March 31, 2017
Last verified: March 2017
This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.

Condition Intervention Phase
Multiple Sclerosis Drug: ACT-128800 Dose 1 Drug: Placebo Drug: ACT-128800 Dose 2 Drug: ACT-128800 Dose 3 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Actelion:

Primary Outcome Measures:
  • Cumulative number of new gadolinium-enhancing lesions per patient recorded on four-weekly T1-weighted magnetic resonance imaging (MRI) scans [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Annualized confirmed relapse rate [ Time Frame: 24 weeks ]
  • Time to first confirmed relapse [ Time Frame: 24 weeks ]

Enrollment: 464
Study Start Date: October 1, 2009
Study Completion Date: July 1, 2011
Primary Completion Date: June 1, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACT-128800 Dose 1
ACT-128800 Dose 1
Drug: ACT-128800 Dose 1
ACT-128800 (Dose 1) administered orally once daily
Experimental: ACT-128800 Dose 2
ACT-128800 Dose 2
Drug: ACT-128800 Dose 2
ACT-128800 (Dose 2) administered orally once daily
Experimental: ACT-128800 Dose 3
ACT-128800 Dose 3
Drug: ACT-128800 Dose 3
ACT-128800 (Dose 3) administered orally once daily
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Matching placebo administered orally once daily


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01006265

  Show 115 Study Locations
Sponsors and Collaborators
Study Director: Actelion Pharmaceuticals Actelion
  More Information

Responsible Party: Actelion Identifier: NCT01006265     History of Changes
Other Study ID Numbers: AC-058B201
Study First Received: October 30, 2009
Last Updated: March 31, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases processed this record on August 18, 2017