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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 2, 2009
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Actelion

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

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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


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




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 ]


Information from the National Library of Medicine

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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.


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


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Locations
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United States, Arizona
Clinical Investigative Site 3132
Scottsdale, Arizona, United States, 85259
Clinical Investigative Site 3100
Tuscon, Arizona, United States, 85741
United States, California
Clinical Investigative Site 3115
Sacremento, California, United States, 95817
Clinical Investigative Site 3117
Stanford, California, United States, 94305
United States, Florida
Clinical Invesigative 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, Maryland
Clinical Investigative Site 3118
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Clinical Investigative Site 3133
Worcester, Massachusetts, United States, 01605
United States, Missouri
Clinical Investigator 3136
St Louis, Missouri, United States, 63100
United States, New Jersey
Clinical Investigative Site # 3135
Newark, New Jersey, United States, 07103
United States, New York
Clinical Investigative Site 3129
Latham, New York, United States, 12110
Clinical Investigative Site # 3128
New York, New York, United States, 10032
Clinical Investigative Site 3127
Schenectady, New York, United States, 12308
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 Investigator 3126
Akron, Ohio, United States, 44320
Clinical Investigative Site 3113
Cincinnati, Ohio, United States, 45219
Clinical Investigative Site 3130
Columbus, Ohio, United States, 43221
United States, Oregon
Clinical Investigator 3104
Portland, Oregon, United States, 97225
United States, Pennsylvania
Clinical Investigative Site 3125
Philadelphia, Pennsylvania, United States, 19107
United States, Vermont
Clinical Investigative Site 3112
Burlington, Vermont, United States, 05401
United States, Virginia
Clinical Investigative Site 3111
Richmond, Virginia, United States, 23298
United States, Washington
Clinical Investigative Site 3102
Kirkland, Washington, United States, 98034
Australia
Clinical Investigative Site # 1001
Fitzroy, Australia, 3065
Clinical Investigative Site 1000
Westmead, Australia, 2145
Austria
Clinical Investigative Site 1102
Amstetten, Austria, 3300
Clinical Investigative Site 1100
St Polten, Austria, 3100
Clinical Investigative Site 1101
Vienna, Austria, 1090
Belgium
Clinical Investigative Site 1201
La Louviere, Belgium, 7100
Clinical Investigative Site # 1205
Liege, Belgium, 4000
Clinical Investigative Site 1204
Ottignies, Belgium, 1340
Clinical Investigative Site 1203
Sijsele-Damme, Belgium, 8340
Bulgaria
Clinical Investigative Site 1302
Sofia, Bulgaria, 1309
Clinical Investigative Site 1301
Sofia, Bulgaria, 1431
Clinical Investigative Site 1303
Varna, Bulgaria, 9010
Clinical Investigative Site 1304
Varna, Bulgaria, 9010
Canada, British Columbia
Clinical Investigative Site 1401
Burbaby, British Columbia, Canada, V5G 2X6
Canada
Clinical Investigative Site # 1401
Burnaby, Canada, V5G 2X6
Clinical Investigative Site 1400
Ottawa, Canada, K1H 8L6
Czech Republic
Clinical Investigative Site 1502
Brno, Czech Republic, 656 91
Clinical Investigative Site 1506
Jihlava, Czech Republic, 586 33
Clinical Investigative Site 1504
Olomouc, Czech Republic, 775 20
Clinical Investigative Site 1501
Ostrava-Poruba, Czech Republic, 70852
Clinical Investigative Site 1500
Praha, Czech Republic, 128 08
Clinical Investigative Site 1503
Teplice, Czech Republic
Finland
Clinical Investigative Site 1600
Helsinki, Finland, 00100
Clinical Investigative Site 1601
Hyvinkaa, Finland, 05800
Clinical Investigative Site 1603
Tampere, Finland, 33520
Clinical Investigative Site 1602
Turku, Finland, 20100
France
Clinical Investigative Site 1701
Montpellier Cedex, France, 34295
Germany
Clinical Investigative Site # 1806
Bayreuth, Germany, 95445
Clinical Investigative 1807
Berlin, Germany, 10117
Clinical Investigative Site 1803
Berlin, Germany, 13347
Clinical Investigative site 1800
Dusseldorf, Germany, 40225
Clinical Investigative Site 1802
Essen, Germany, 45147
Clinical Investigative Site 1805
Homburg/Saar, Germany, 66421
Clinical Investigative Site 1804
Ulm, Germany, 89081
Hungary
Clinical Investigative Site 1905
Budapest, Hungary, 1134
Clinical Investigative Site # 1904
Budapest, Hungary, H-1115
Clinical Investigative Site 1908
Budapest, Hungary, H-1145
Clinical Investigative Site 1902
Gyor, Hungary, 11-9024
Clinical Investigative Site 1900
Petofi, Hungary, 2500
Clinical Investigative Site 1901
Szentpeteri-Kapu, Hungary, 3526
Israel
Clinical Investigative Site 2000
Ashkelon, Israel, 78278
Clinical Investigative Site 2003
Tel-Aviv, Israel, 64239
Clinical Investigative Site 2001
Tel-Hashomer, Israel, 52621
Clinical Investigative Site 2002
Zerifin, Israel, 70300
Italy
Clinical Investigative Site 2101
Gallarte, Italy, 21013
Clinical Investigative Site 2104
Genova, Italy, 16132
Clinical Investigative Site # 2106
Milan, 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
Clinical Investigative Site 2202
Nijmegen, Netherlands, 6533
Clinical Investigative Site 2201
Sittard-Geleen, Netherlands, 6162
Poland
Clinical Investigative Site 2305
Katowice, Poland, 47-752
Clinical Investigative Site 2303
Poznan, Poland, 60-355
Clinical Investigative Site 2304
Warsaw, Poland, 02-957
Clinical Investigative Site 2302
Wroclaw, Poland, 50-044
Romania
Clinical Investigative Site 2400
Bucuresti, Romania, 022903
Clinical Investigative Site 2401
Cluj-Napoca, Romania, 428063
Clinical Investigative Site 2402
Timisoara, Romania, 300736
Russian Federation
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 # 3201
Samara, Russian Federation, 443095
Clinical Investigative Site 3209
Saratov, Russian Federation, 410030
Clinical Investigative Site # 3204
St. Petersburg, Russian Federation, 194354
Clinical Investigative Site 3201
St. Petersburg, Russian Federation, 197022
Clinical Investigative Site 3200
St. Petersburg, Russian Federation, 197376
Clinical Investigative Site 3208
Ufa, Russian Federation, 450005
Serbia
Clinical Investigative Site 2501
Belgrade, Serbia, 11000
Clinical Investigative Site 2503
Kragujevac, Serbia, 34000
Clinical Investigative Site 2502
Nis, Serbia, 18000
Spain
Clinical Investigative Site 2706
Barcelona, Spain, 08035
Clinical Investigative Site 2702
Madrid, Spain, 28040
Clinical Investigative Site 2705
Madrid, Spain, 28222
Clinical Investigative Site 2701
Malaga, Spain, 29010
Clinical Investigative Site 2700
Sevilla, Spain, 41009
Clinical Investigative Site 2704
Valencia, Spain, 46009
Sweden
Clinical Investigative Site 2802
Goteburg, Sweden, 41345
Clinical Investigative Site 2800
Stockholm, Sweden, 17176
Clinical Investigative Site 2801
Umed, Sweden, 90185
Switzerland
Clinical Investigative Site 2901
Lugano, Switzerland, CH-6900
Clinical Investigative Site 2900
St Gallen, Switzerland, CH-9007
Ukraine
Clinical Investigative Site 3302
Chernihiv, Ukraine, 14029
Clinical Investigative Site 3303
Dnipropetrovsk, Ukraine, 49044
Clinical Investigative Site 3300
Kyiv, Ukraine, 03110
Clinical Investigative Site 3304
Odesa, Ukraine, 65000
United Kingdom
Clinical Investigative Site 3003
Bristol, United Kingdom, BS16 1LE
Clinical Investigative Site 3004
Devon, United Kingdom, PL6 SBX
Clinical Investigative Site 3002
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Actelion
Investigators
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Study Director: Actelion Pharmaceuticals Actelion

Publications of Results:
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01006265     History of Changes
Other Study ID Numbers: AC-058B201
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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