Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01006265
Recruitment Status : Completed
First Posted : November 1, 2009
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. Annualized confirmed relapse rate [ Time Frame: 24 weeks ]
  2. Time to first confirmed relapse [ Time Frame: 24 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Show Show 115 study locations
Sponsors and Collaborators
Actelion
Investigators
Layout table for investigator information
Study Director: Actelion Pharmaceuticals Actelion
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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