Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01093326
First received: March 24, 2010
Last updated: April 14, 2016
Last verified: April 2016
  Purpose
This study is an extension to the study AC-058B201 and will investigate the long-term safety, tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple sclerosis.

Condition Intervention Phase
Multiple Sclerosis
Drug: Ponesimod 10 mg
Drug: Ponesimod 20 mg
Drug: Ponesimod 40 mg
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, Parallel-group Extension to Study AC-058B201 to Investigate the Long-term Safety, Tolerability, and Efficacy of Three Doses of Ponesimod, an Oral S1P1 Receptor Agonist, in Patients With Relapsing-remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Annualized confirmed relapse rate [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]
    IMPORTANT NOTE: Only exploratory analyses will be performed.

  • Time to first confirmed relapse [ Time Frame: 240 weeks ] [ Designated as safety issue: No ]
    IMPORTANT NOTE: Only exploratory analyses will be performed.

  • Time to 3 month confirmed disability progression up to end of the study [ Time Frame: Estimated period of time over which the event is assessed: 3 months. The time to event is defined as the time from initiation of study treatment until the first EDSS assessment meeting the criteria for disability progression. ] [ Designated as safety issue: No ]
    IMPORTANT NOTE: Only exploratory analyses will be performed. Disability progression is defined as an increase of at least one full point in the Expanded Disability Status Scale (EDSS) score (or 1.5 points if the baseline EDSS was 0, or 0.5 points if the baseline EDSS was equal or greater than 5.5) with or without relapse, confirmed at the next scheduled EDSS assessment at least 12 weeks later (or if missing, at the next available scheduled EDSS assessment).

  • Time to 6 month confirmed disability progression up to end of the study [ Time Frame: Estimated period of time over which the event is assessed: 6 months. The time to event is defined as the time from initiation of study treatment until the first EDSS assessment meeting the criteria for disability progression. ] [ Designated as safety issue: No ]
    IMPORTANT NOTE: Only exploratory analyses will be performed. Disability progression is defined as an increase of at least one full point in the Expanded Disability Status Scale (EDSS) score (or 1.5 points if the baseline EDSS was 0, or 0.5 points if the baseline EDSS was equal or greater than 5.5) with or without relapse, confirmed at the next scheduled EDSS assessment at least 12 weeks later (or if missing, at the next available scheduled EDSS assessment).


Other Outcome Measures:
  • (Serious) Adverse Events [ Time Frame: Through study completion, for approx. 10 years: during Treatment Period (incl. Transition), i.e. study drug administration plus 7 days, and during the Follow up, i.e. from 8 until 30 days (Period 1) or until 90 days (Period 2) after study drug discontin. ] [ Designated as safety issue: Yes ]

Enrollment: 353
Study Start Date: May 2010
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ponesimod 10 mg
Ponesimod 10 mg oral use
Drug: Ponesimod 10 mg
Ponesimod 10 mg oral use
Experimental: Ponesimod 20 mg
Ponesimod 20 mg oral use
Drug: Ponesimod 20 mg
Ponesimod 20 mg oral use
Experimental: Ponesimod 40 mg
Ponesimod 40 mg oral use
Drug: Ponesimod 40 mg
Ponesimod 40 mg oral use

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who completed study treatment at their regular Week 24 (End of treatment) visit within the core study AC-058B201.
  2. Signed informed consent for participating in the extension study.

Exclusion Criteria:

1. Any clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the patient at risk by participating in the extension 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: NCT01093326

  Hide Study Locations
Locations
United States, Arizona
Clinical Investigative Site 3100
Phoenix, Arizona, United States, 85018
Clinical Investigative Site 3132
Scottsdale, Arizona, United States, 85259
United States, California
Clinical Investigative Site 3115
Sacramento, California, United States, 95817
Clinical Investigative Site 3117
Stanford, California, United States, 94305
United States, Florida
Clinical Investigative Site 3116
Sarasota, Florida, United States, 34233
United States, Indiana
Clinical Investigative Site 3101
Indianapolis, Indiana, United States, 46202
United States, Kansas
Clinical Investigative Site 3105
Kansas City, Kansas, United States, 66160
Clinical Investigative Site 3107
Lenexa, Kansas, United States, 66214
United States, New York
Clinical Investigative Site #3129
Latham, New York, United States, 12110
Clinical Investigative Site 3127
Schenectady, New York, United States, 12309
Clinical Investigative Site 3120
Stony Brook, New York, United States, 11794
United States, North Carolina
Clinical Investigative Site 3119
Raleigh, North Carolina, United States, 27607
United States, Ohio
Clinical Investigative Site 3113
Cincinnati, Ohio, United States, 45219
Clinical Investigative Site 3130
Columbus, Ohio, United States, 43221
United States, Vermont
Clinical Investigative Site 3112
Burlington, Vermont, United States, 05401
United States, Washington
Clinical Investigative Site 3102
Kirkland, Washington, United States, 98034
Austria
Clinical Investigative Site 1101
Vienna, Austria, 1090
Bulgaria
Clinical Investigative Site 1302
Sofia, Bulgaria, 1309
Clinical Investigative Site # 1301
Sofia, Bulgaria, 1431
Canada, Ontario
Clinical Investigative Site 1400
Ottawa, Ontario, Canada, K1H 8L6
Czech Republic
Clinical Investigative Site # 1502
Brno, Czech Republic, 65691
Clinical Investigative Site 1506
Jihlava, Czech Republic, 58633
Clinical Investigative Site # 1504
Olomouc, Czech Republic, 77520
Clinical Investigative Site # 1501
Poruba, Czech Republic, 708 52
Clinical Investigative Site # 1500
Praha, Czech Republic, 128 08
Clinical Investigative Site # 1503
Teplice, Czech Republic, 41529
Finland
Clinical Investigative Site 1600
Helsinki, Finland, 00100
Clinical Investigative Site # 1601
Hyvinkaa, Finland, 05800
Clinical Investigative Site 1603
Tampere, Finland, 33520
Clinical Investigative 1602
Turku, Finland, 20100
France
Clinical Investigative Site 1701
Montpellier, France, 34295
Germany
Clinical Investigative Site 1807
Berlin, Germany, 10117
Clinical Investigative Site 1804
Ulm, Germany, 89081
Hungary
Clinical Investigative Site 1905
Budapest, Hungary, 1134
Clinical Investigative Site 1908
Budapest, Hungary, 1145
Clinical Investigative Site 1904
Budapest, Hungary, H-1115
Clinical Investigative Site 1900
Esztergom, Hungary, 2500
Clinical Investigative Site 1902
Gyor, Hungary, H-9024
Clinival Investigative Site # 1901
Miskolc, Hungary, 3256
Israel
Clinical Investigative Site # 2001
Ramat Gan, Israel, 52621
Clinical Investigative Site 2002
Zerifin, Israel, 70300
Italy
Clinical Investigative Site #2101
Gallarate, Italy, 21013
Clinical Investigative Site 2104
Genova, Italy, 16132
Clinical Investigative Site 2106
Milano, Italy, 20132
Clinical Investigative Site 2102
Padova, Italy, 35128
Clinical Investigative Site # 2103
Roma, Italy, 00189
Clinical Investigative Site 2105
Siena, Italy, 53100
Netherlands
Clinical Investigative Site 2203
Breda, Netherlands, 4818
Poland
Clinical Investigative Site # 2305
Katowice, Poland, 47752
Clinical Investigative Site #2303
Poznan, Poland, 60355
Clinical Investigative Site # 2304
Warszawa, Poland, 02957
Clinical Investigative Site # 2302
Wroclaw, Poland, 50044
Romania
Clinical Investigative Site 2401
Cluj-Napoca, Romania, 400347
Clinical Investigative Site 2402
Timisoara, Romania, 300736
Russian Federation
Clinical Investigative Site 3205
Kazan, Russian Federation, 420132
Clinical Investigative Site 3202
Moscow, Russian Federation, 127018
Clinical Investigative Site 3203
Nizhniy Novgorod, Russian Federation, 603155
Clinical Investigative Site 3206
Pyatigorsk, Russian Federation, 357538
Clinical Investigative Site 3207
Samara, Russian Federation, 443095
Clinical Investigative Site 3209
Saratov, Russian Federation, 410030
Clinical Investigative Site 3200
St. Petersburg, Russian Federation, 197376
Clinical Investigative Site 3201
St. Petersburg, Russian Federation, 197022
Clinical Investigative Site 3204
St. Petersburg, Russian Federation, 194354
Clinical Investigative Site 3208
Ufa, Russian Federation, 450005
Serbia
Clinical Investigative 2501
Belgrade, Serbia, 11000
Clinical Investigative Site # 2503
Kragujevae, Serbia, 34000
Clinical Investigative Site 2502
Nis, Serbia, 18000
Spain
Clinical Investigative Site 2705
Madrid, Spain, 28222
Clinical Investigative Site #2701
Malaga, Spain, 29010
Clinical Investigative Site 2700
Sevilla, Spain, 41009
Sweden
Clinical Investigative Site 2802
Goteborg, Sweden, 41345
Clinical Investigative Site # 2800
Stockholm, Sweden, 17176
Clinical Investigative Site # 2801
Umea, Sweden, 90185
Switzerland
Clinical Investigative Site 2901
Lugano, Switzerland, 6900
Ukraine
Clinical Investigative Site 3302
Chernihiv, Ukraine, 14029
Clinical Investigative Site 3303
Dnipropetrovsk, Ukraine, 49027
Clinical Investigative Site 3300
Kyiv, Ukraine, 03110
Clinical Investigative Site 3304
Odesa, Ukraine, 65000
United Kingdom
Clinical Investigative Site 3003
Bristol, United Kingdom
Clinical Investigative Site 3002
London, United Kingdom, SE5 9RS
Clinical Investigative Site 3004
Plymouth, United Kingdom, PL6 8DX
Sponsors and Collaborators
Actelion
  More Information

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01093326     History of Changes
Other Study ID Numbers: AC-058B202 
Study First Received: March 24, 2010
Last Updated: April 14, 2016
Health Authority: Finland: Ethics Committee
Spain: Comité Ético de Investigación Clínica
United Kingdom: Research Ethics Committee
Poland: Ethics Committee
Switzerland: Swissmedic
United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Germany: Ethics Commission
Austria: Ethikkommission
Romania: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Germany: Federal Institute for Drugs and Medical Devices
Russia: Ethics Committee
Canada: Ethics Review Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Poland: The Central Register of Clinical Trials
Italy: Ethics Committee
Serbia: Ethics Committee
Hungary: National Institute of Pharmacy
Netherlands: Independent Ethics Committee
Ukraine: Ethics Committee
Sweden: Regional Ethical Review Board
Ukraine: State Pharmacological Center - Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Hungary: Research Ethics Medical Committee
Israel: Ministry of Health
Netherlands: Medical Ethics Review Committee (METC)
Italy: The Italian Medicines Agency
Sweden: Medical Products Agency
Romania: National Medicines Agency
United States: Institutional Review Board
Bulgaria: Bulgarian Drug Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Austria: Federal Office for Safety in Health Care
Spain: Ethics Committee
Czech Republic: Ethics Committee
Switzerland: Ethikkommission
France: Committee for the Protection of Personnes
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Bulgaria: Ethics committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 27, 2016