Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis
NCT ID: NCT01006265
Last Updated: 2025-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
464 participants
INTERVENTIONAL
2009-10-01
2011-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ACT-128800 Dose 1
ACT-128800 Dose 1
ACT-128800 Dose 1
ACT-128800 (Dose 1) administered orally once daily
ACT-128800 Dose 2
ACT-128800 Dose 2
ACT-128800 Dose 2
ACT-128800 (Dose 2) administered orally once daily
ACT-128800 Dose 3
ACT-128800 Dose 3
ACT-128800 Dose 3
ACT-128800 (Dose 3) administered orally once daily
Placebo
Matching placebo
Placebo
Matching placebo administered orally once daily
Interventions
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ACT-128800 Dose 1
ACT-128800 (Dose 1) administered orally once daily
Placebo
Matching placebo administered orally once daily
ACT-128800 Dose 2
ACT-128800 (Dose 2) administered orally once daily
ACT-128800 Dose 3
ACT-128800 (Dose 3) administered orally once daily
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients currently treated for an autoimmune disorder other than MS.
* Contraindications for MRI.
* Ongoing bacterial, viral, or fungal infection.
* History or presence of malignancy.
18 Years
55 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Principal Investigators
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Actelion Pharmaceuticals
Role: STUDY_DIRECTOR
Actelion
Locations
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Clinical Investigative Site 3132
Scottsdale, Arizona, United States
Clinical Investigative Site 3100
Tucson, Arizona, United States
Clinical Investigative Site 3115
Sacramento, California, United States
Clinical Investigative Site 3117
Stanford, California, United States
Clinical Invesigative Site 3116
Sarasota, Florida, United States
Clinical Investigative Site 3101
Indianapolis, Indiana, United States
Clinical Investigative Site 3105
Kansas City, Kansas, United States
Clinical Investigative Site 3107
Lenexa, Kansas, United States
Clinical Investigative Site 3118
Baltimore, Maryland, United States
Clinical Investigative Site 3133
Worcester, Massachusetts, United States
Clinical Investigator 3136
St Louis, Missouri, United States
Clinical Investigative Site # 3135
Newark, New Jersey, United States
Clinical Investigative Site 3129
Latham, New York, United States
Clinical Investigative Site # 3128
New York, New York, United States
Clinical Investigative Site 3127
Schenectady, New York, United States
Clinical Investigative Site 3120
Stony Brook, New York, United States
Clinical Investigative Site 3119
Raleigh, North Carolina, United States
Clinical Investigator 3126
Akron, Ohio, United States
Clinical Investigative Site 3113
Cincinnati, Ohio, United States
Clinical Investigative Site 3130
Columbus, Ohio, United States
Clinical Investigator 3104
Portland, Oregon, United States
Clinical Investigative Site 3125
Philadelphia, Pennsylvania, United States
Clinical Investigative Site 3112
Burlington, Vermont, United States
Clinical Investigative Site 3111
Richmond, Virginia, United States
Clinical Investigative Site 3102
Kirkland, Washington, United States
Clinical Investigative Site # 1001
Fitzroy, , Australia
Clinical Investigative Site 1000
Westmead, , Australia
Clinical Investigative Site 1102
Amstetten, , Austria
Clinical Investigative Site 1100
Sankt Pölten, , Austria
Clinical Investigative Site 1101
Vienna, , Austria
Clinical Investigative Site 1201
La Louvière, , Belgium
Clinical Investigative Site # 1205
Liège, , Belgium
Clinical Investigative Site 1204
Ottignies, , Belgium
Clinical Investigative Site 1203
Sijsele-Damme, , Belgium
Clinical Investigative Site 1302
Sofia, , Bulgaria
Clinical Investigative Site 1301
Sofia, , Bulgaria
Clinical Investigative Site 1303
Varna, , Bulgaria
Clinical Investigative Site 1304
Varna, , Bulgaria
Clinical Investigative Site 1401
Burbaby, British Columbia, Canada
Clinical Investigative Site # 1401
Burnaby, , Canada
Clinical Investigative Site 1400
Ottawa, , Canada
Clinical Investigative Site 1502
Brno, , Czechia
Clinical Investigative Site 1506
Jihlava, , Czechia
Clinical Investigative Site 1504
Olomouc, , Czechia
Clinical Investigative Site 1501
Ostrava-Poruba, , Czechia
Clinical Investigative Site 1500
Prague, , Czechia
Clinical Investigative Site 1503
Teplice, , Czechia
Clinical Investigative Site 1600
Helsinki, , Finland
Clinical Investigative Site 1601
Hyvinkää, , Finland
Clinical Investigative Site 1603
Tampere, , Finland
Clinical Investigative Site 1602
Turku, , Finland
Clinical Investigative Site 1701
Montpellier, , France
Clinical Investigative Site # 1806
Bayreuth, , Germany
Clinical Investigative 1807
Berlin, , Germany
Clinical Investigative Site 1803
Berlin, , Germany
Clinical Investigative site 1800
Düsseldorf, , Germany
Clinical Investigative Site 1802
Essen, , Germany
Clinical Investigative Site 1805
Homburg/Saar, , Germany
Clinical Investigative Site 1804
Ulm, , Germany
Clinical Investigative Site 1905
Budapest, , Hungary
Clinical Investigative Site # 1904
Budapest, , Hungary
Clinical Investigative Site 1908
Budapest, , Hungary
Clinical Investigative Site 1902
Győr, , Hungary
Clinical Investigative Site 1900
Petofi, , Hungary
Clinical Investigative Site 1901
Szentpeteri-Kapu, , Hungary
Clinical Investigative Site 2000
Ashkelon, , Israel
Clinical Investigative Site 2003
Tel Aviv, , Israel
Clinical Investigative Site 2001
Tel Litwinsky, , Israel
Clinical Investigative Site 2002
Ẕerifin, , Israel
Clinical Investigative Site 2101
Gallarte, , Italy
Clinical Investigative Site 2104
Genova, , Italy
Clinical Investigative Site # 2106
Milan, , Italy
Clinical Investigative Site 2102
Padua, , Italy
Clinical Investigative Site 2103
Roma, , Italy
Clinical Investigative Site 2105
Siena, , Italy
Clinical Investigative Site 2203
Breda, , Netherlands
Clinical Investigative Site 2202
Nijmegen, , Netherlands
Clinical Investigative Site 2201
Sittard-Geleen, , Netherlands
Clinical Investigative Site 2305
Katowice, , Poland
Clinical Investigative Site 2303
Poznan, , Poland
Clinical Investigative Site 2304
Warsaw, , Poland
Clinical Investigative Site 2302
Wroclaw, , Poland
Clinical Investigative Site 2400
Bucharest, , Romania
Clinical Investigative Site 2401
Cluj-Napoca, , Romania
Clinical Investigative Site 2402
Timișoara, , Romania
Clinical Investigative Site # 3202
Moscow, , Russia
Clinical Investigative Site # 3203
Nizhny Novgorod, , Russia
Clinical Investigative Site # 3206
Pyatigorsk, , Russia
Clinical Investigative Site # 3204
Saint Petersburg, , Russia
Clinical Investigative Site 3201
Saint Petersburg, , Russia
Clinical Investigative Site 3200
Saint Petersburg, , Russia
Clinical Investigative Site # 3201
Samara, , Russia
Clinical Investigative Site 3209
Saratov, , Russia
Clinical Investigative Site 3208
Ufa, , Russia
Clinical Investigative Site 2501
Belgrade, , Serbia
Clinical Investigative Site 2503
Kragujevac, , Serbia
Clinical Investigative Site 2502
Niš, , Serbia
Clinical Investigative Site 2706
Barcelona, , Spain
Clinical Investigative Site 2702
Madrid, , Spain
Clinical Investigative Site 2705
Madrid, , Spain
Clinical Investigative Site 2701
Málaga, , Spain
Clinical Investigative Site 2700
Seville, , Spain
Clinical Investigative Site 2704
Valencia, , Spain
Clinical Investigative Site 2802
Gothenburg, , Sweden
Clinical Investigative Site 2800
Stockholm, , Sweden
Clinical Investigative Site 2801
Umed, , Sweden
Clinical Investigative Site 2901
Lugano, , Switzerland
Clinical Investigative Site 2900
Sankt Gallen, , Switzerland
Clinical Investigative Site 3302
Chernihiv, , Ukraine
Clinical Investigative Site 3303
Dnipropetrovsk, , Ukraine
Clinical Investigative Site 3300
Kyiv, , Ukraine
Clinical Investigative Site 3304
Odesa, , Ukraine
Clinical Investigative Site 3003
Bristol, , United Kingdom
Clinical Investigative Site 3004
Devon, , United Kingdom
Clinical Investigative Site 3002
London, , United Kingdom
Countries
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References
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Olsson T, Boster A, Fernandez O, Freedman MS, Pozzilli C, Bach D, Berkani O, Mueller MS, Sidorenko T, Radue EW, Melanson M. Oral ponesimod in relapsing-remitting multiple sclerosis: a randomised phase II trial. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1198-208. doi: 10.1136/jnnp-2013-307282. Epub 2014 Mar 21.
Gisleskog PO, Valenzuela B, Scherz T, Burcklen M, Perez-Ruixo JJ, Poggesi I. An Exposure-Response Analysis of the Clinical Efficacy of Ponesimod in a Randomized Phase II Study in Patients with Multiple Sclerosis. Clin Pharmacokinet. 2021 Sep;60(9):1227-1237. doi: 10.1007/s40262-021-01020-2. Epub 2021 Apr 29.
Related Links
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A 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
Other Identifiers
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AC-058B201
Identifier Type: -
Identifier Source: org_study_id
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