Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT01006265 |
Recruitment Status :
Completed
First Posted : November 1, 2009
Last Update Posted : April 4, 2017
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 464 participants |
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 |
Study Start Date : | October 1, 2009 |
Actual Primary Completion Date : | June 1, 2011 |
Actual Study Completion Date : | July 1, 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: ACT-128800 Dose 1
ACT-128800 Dose 1
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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 |
- Cumulative number of new gadolinium-enhancing lesions per patient recorded on four-weekly T1-weighted magnetic resonance imaging (MRI) scans [ Time Frame: 24 weeks ]
- Annualized confirmed relapse rate [ Time Frame: 24 weeks ]
- Time to first confirmed relapse [ Time Frame: 24 weeks ]

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, Learn About Clinical Studies.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006265

Study Director: | Actelion Pharmaceuticals | Actelion |
Responsible Party: | Actelion |
ClinicalTrials.gov Identifier: | NCT01006265 |
Other Study ID Numbers: |
AC-058B201 |
First Posted: | November 1, 2009 Key Record Dates |
Last Update Posted: | April 4, 2017 |
Last Verified: | March 2017 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS |
Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |