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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.
Sponsor:
Actelion
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01006265
First received: October 30, 2009
Last updated: March 31, 2017
Last verified: March 2017
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Purpose
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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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 ClinicalTrials.gov identifier: NCT01006265
Show 115 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006265
Show 115 Study Locations
Sponsors and Collaborators
Actelion
Investigators
| Study Director: | Actelion Pharmaceuticals | Actelion |
More Information
Publications:
| Responsible Party: | Actelion |
| ClinicalTrials.gov 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:
|
Sclerosis 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 |
ClinicalTrials.gov processed this record on August 18, 2017