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NCT01006265 Clinical Trial

Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01006265
Other study ID # AC-058B201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 1, 2009
Est. completion date July 1, 2011

Study information
Verified date February 2022
Source Actelion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 464
Est. completion date July 1, 2011
Est. primary completion date June 1, 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
Australia Clinical Investigative Site # 1001 Fitzroy
Australia Clinical Investigative Site 1000 Westmead
Austria Clinical Investigative Site 1102 Amstetten
Austria Clinical Investigative Site 1100 St Polten
Austria Clinical Investigative Site 1101 Vienna
Belgium Clinical Investigative Site 1201 La Louviere
Belgium Clinical Investigative Site # 1205 Liege
Belgium Clinical Investigative Site 1204 Ottignies
Belgium Clinical Investigative Site 1203 Sijsele-Damme
Bulgaria Clinical Investigative Site 1301 Sofia
Bulgaria Clinical Investigative Site 1302 Sofia
Bulgaria Clinical Investigative Site 1303 Varna
Bulgaria Clinical Investigative Site 1304 Varna
Canada Clinical Investigative Site 1401 Burbaby British Columbia
Canada Clinical Investigative Site # 1401 Burnaby
Canada Clinical Investigative Site 1400 Ottawa
Czechia 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 Praha
Czechia Clinical Investigative Site 1503 Teplice
Finland Clinical Investigative Site 1600 Helsinki
Finland Clinical Investigative Site 1601 Hyvinkaa
Finland Clinical Investigative Site 1603 Tampere
Finland Clinical Investigative Site 1602 Turku
France Clinical Investigative Site 1701 Montpellier Cedex
Germany Clinical Investigative Site # 1806 Bayreuth
Germany Clinical Investigative 1807 Berlin
Germany Clinical Investigative Site 1803 Berlin
Germany Clinical Investigative site 1800 Dusseldorf
Germany Clinical Investigative Site 1802 Essen
Germany Clinical Investigative Site 1805 Homburg/Saar
Germany Clinical Investigative Site 1804 Ulm
Hungary Clinical Investigative Site # 1904 Budapest
Hungary Clinical Investigative Site 1905 Budapest
Hungary Clinical Investigative Site 1908 Budapest
Hungary Clinical Investigative Site 1902 Gyor
Hungary Clinical Investigative Site 1900 Petofi
Hungary Clinical Investigative Site 1901 Szentpeteri-Kapu
Israel Clinical Investigative Site 2000 Ashkelon
Israel Clinical Investigative Site 2003 Tel-Aviv
Israel Clinical Investigative Site 2001 Tel-Hashomer
Israel Clinical Investigative Site 2002 Zerifin
Italy Clinical Investigative Site 2101 Gallarte
Italy Clinical Investigative Site 2104 Genova
Italy Clinical Investigative Site # 2106 Milan
Italy Clinical Investigative Site 2102 Padova
Italy Clinical Investigative Site 2103 Roma
Italy Clinical Investigative Site 2105 Siena
Netherlands Clinical Investigative Site 2203 Breda
Netherlands Clinical Investigative Site 2202 Nijmegen
Netherlands Clinical Investigative Site 2201 Sittard-Geleen
Poland Clinical Investigative Site 2305 Katowice
Poland Clinical Investigative Site 2303 Poznan
Poland Clinical Investigative Site 2304 Warsaw
Poland Clinical Investigative Site 2302 Wroclaw
Romania Clinical Investigative Site 2400 Bucuresti
Romania Clinical Investigative Site 2401 Cluj-Napoca
Romania Clinical Investigative Site 2402 Timisoara
Russian Federation Clinical Investigative Site # 3202 Moscow
Russian Federation Clinical Investigative Site # 3203 Nizhniy Novgorod
Russian Federation Clinical Investigative Site # 3206 Pyatigorsk
Russian Federation Clinical Investigative Site # 3201 Samara
Russian Federation Clinical Investigative Site 3209 Saratov
Russian Federation Clinical Investigative Site # 3204 St. Petersburg
Russian Federation Clinical Investigative Site 3200 St. Petersburg
Russian Federation Clinical Investigative Site 3201 St. Petersburg
Russian Federation Clinical Investigative Site 3208 Ufa
Serbia Clinical Investigative Site 2501 Belgrade
Serbia Clinical Investigative Site 2503 Kragujevac
Serbia Clinical Investigative Site 2502 Nis
Spain Clinical Investigative Site 2706 Barcelona
Spain Clinical Investigative Site 2702 Madrid
Spain Clinical Investigative Site 2705 Madrid
Spain Clinical Investigative Site 2701 Malaga
Spain Clinical Investigative Site 2700 Sevilla
Spain Clinical Investigative Site 2704 Valencia
Sweden Clinical Investigative Site 2802 Goteburg
Sweden Clinical Investigative Site 2800 Stockholm
Sweden Clinical Investigative Site 2801 Umed
Switzerland Clinical Investigative Site 2901 Lugano
Switzerland Clinical Investigative Site 2900 St Gallen
Ukraine Clinical Investigative Site 3302 Chernihiv
Ukraine Clinical Investigative Site 3303 Dnipropetrovsk
Ukraine Clinical Investigative Site 3300 Kyiv
Ukraine Clinical Investigative Site 3304 Odesa
United Kingdom Clinical Investigative Site 3003 Bristol
United Kingdom Clinical Investigative Site 3004 Devon
United Kingdom Clinical Investigative Site 3002 London
United States Clinical Investigator 3126 Akron Ohio
United States Clinical Investigative Site 3118 Baltimore Maryland
United States Clinical Investigative Site 3112 Burlington Vermont
United States Clinical Investigative Site 3113 Cincinnati Ohio
United States Clinical Investigative Site 3130 Columbus Ohio
United States Clinical Investigative Site 3101 Indianapolis Indiana
United States Clinical Investigative Site 3105 Kansas City Kansas
United States Clinical Investigative Site 3102 Kirkland Washington
United States Clinical Investigative Site 3129 Latham New York
United States Clinical Investigative Site 3107 Lenexa Kansas
United States Clinical Investigative Site # 3128 New York New York
United States Clinical Investigative Site # 3135 Newark New Jersey
United States Clinical Investigative Site 3125 Philadelphia Pennsylvania
United States Clinical Investigator 3104 Portland Oregon
United States Clinical Investigative Site 3119 Raleigh North Carolina
United States Clinical Investigative Site 3111 Richmond Virginia
United States Clinical Investigative Site 3115 Sacramento California
United States Clinical Investigator 3136 Saint Louis Missouri
United States Clinical Invesigative Site 3116 Sarasota Florida
United States Clinical Investigative Site 3127 Schenectady New York
United States Clinical Investigative Site 3132 Scottsdale Arizona
United States Clinical Investigative Site 3117 Stanford California
United States Clinical Investigative Site 3120 Stony Brook New York
United States Clinical Investigative Site 3100 Tucson Arizona
United States Clinical Investigative Site 3133 Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Actelion

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  Sweden,  Switzerland,  Ukraine,  United Kingdom, 

References & Publications (1)

Olsson T, Boster A, Fernández Ó, 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(1 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24 Cumulative Number of new T1 gadolinium-enhancing (Gd+) lesions per year on magnetic resonance imaging (MRI) scan from Week 12 to Week 24 were reported. Negative binomial (NB) regression analysis on Per protocol analysis set and imputation was applied for the missing data. Here, MS signifies multiple sclerosis. From Week 12 to 24
Secondary Annualized Confirmed Relapse Rate Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of Multiple Sclerosis (MS), not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicating overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS with information concerning gait and use of assistance. EDSS is ordinal clinical scale ranges 0 (normal neurological examination) to 10(death due to MS) Up to 24 weeks
Secondary Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24 Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of MS, not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicating overall functional impairment assessing Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS with information concerning gait and use of assistance. EDSS is ordinal clinical scale ranges 0 (normal neurological examination) to 10(death due to MS). Kaplan-Meier estimate used for Outcome Measure analysis. Baseline to Week 24
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