ACT-128800 in Relapsing-remitting Multiple Sclerosis - Full Text View

Sponsor:	Actelion
Information provided by (Responsible Party):	Actelion
ClinicalTrials.gov Identifier:	NCT01006265

Purpose

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

Condition	Intervention	Phase
Relapsing-remitting Multiple Sclerosis	Drug: ACT-128800 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Annualized confirmed relapse rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Time to first confirmed relapse [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	464
Study Start Date:	October 2009
Study Completion Date:	July 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Investigational drug - Dose 1	Drug: ACT-128800 ACT-128800 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally once daily
Experimental: Investigational drug - Dose 2	Drug: ACT-128800 ACT-128800 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally once daily
Experimental: Investigational drug - Dose 3	Drug: ACT-128800 ACT-128800 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally once daily
Placebo Comparator: Matching placebo	Drug: Placebo ACT-128800 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally once daily

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006265

Show 109 Study Locations

Sponsors and Collaborators

Actelion

Investigators

Study Director:

Actelion Pharmaceuticals

Actelion

More Information

No publications provided

Responsible Party:	Actelion
ClinicalTrials.gov Identifier:	NCT01006265 History of Changes
Other Study ID Numbers:	AC-058B201
Study First Received:	October 30, 2009
Last Updated:	August 19, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012