ACT-128800 in Relapsing-remitting Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01006265
First received: October 30, 2009
Last updated: September 27, 2012
Last verified: September 2012
  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 2

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:


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
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
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: September 27, 2012
Health Authority: Austria: Federal Office for Safety in Health Care
Austria: Ethikkommission
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ethics committee
Canada: Ethics Review Committee
Canada: Health Canada
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Finland: Ethics Committee
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Hungary: Research Ethics Medical Committee
Israel: Ministry of Health
Italy: Ethics Committee
Italy: The Italian Medicines Agency
Netherlands: Independent Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: The Central Register of Clinical Trials
Romania: Ethics Committee
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Serbia: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Switzerland: Ethikkommission
Switzerland: Swissmedic
Ukraine: Ethics Committee
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration
United States: Institutional Review Board

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 September 22, 2014