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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02425644
Other study ID # AC-058B301
Secondary ID 2012-000540-10
Status Completed
Phase Phase 3
First received
Last updated
Start date June 4, 2015
Est. completion date May 16, 2019

Study information

Verified date January 2023
Source Actelion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis


Recruitment information / eligibility

Status Completed
Enrollment 1133
Est. completion date May 16, 2019
Est. primary completion date May 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: Male and female subjects aged 18 to 55 years with established diagnosis of MS McDonald 2010 with relapsing course from onset (i.e., RRMS and SPMS with superimposed relapses). Subjects must have active disease evidenced by one or more MS attacks with onset within the period of 12 to 1 months prior to randomization, or by two or more MS attacks with onset within the 24 to 1 months prior to randomization, or with one or more gadolinium-enhancing (Gd+) lesion(s) of the brain on an MRI performed within 6 months prior to randomization. Enrolled subjects must be ambulatory (EDSS score of up to 5.5 inclusive) and may be treatment-naïve or previously treated with MS disease modifying therapy. Exclusion Criteria: Subjects with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic,ophthalmological conditions) or lactating or pregnant women are not eligible to enter the study. Subjects with contraindications to MRI or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study are not eligible to enter the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ponesimod
film-coated tablet with 20 mg ponesimod, administered orally once daily in the morning
teriflunomide
film-coated tablet with 14 mg teriflunomide, administered orally once daily in the morning

Locations

Country Name City State
Belarus Investigator Site 3605 Grodno
Belarus Investigator Site 3602 Minsk
Belarus Investigator Site 3603 Minsk
Belarus Investigator Site 3604 Vitebsk
Belarus Investigator Site 3606 Vitebsk
Bosnia and Herzegovina Investigator Site 9104 Sarajevo
Bulgaria Investigator Site 2709 Plovdiv
Bulgaria Investigator Site 2701 Sofia
Bulgaria Investigator Site 2702 Sofia
Bulgaria Investigator Site 2703 Sofia
Bulgaria Investigator Site 2707 Sofia
Bulgaria Investigator Site 2708 Sofia
Bulgaria Investigator Site 2711 Sofia
Canada Investigator Site 8102 Edmonton Alberta
Canada Investigator Site 8113 Greenfield Park Quebec
Canada Investigator Site 8101 Ottawa Ontario
Canada Investigator Site 8120 Victoria British Columbia
Croatia Investigator Site 2506 Osijek
Croatia Investigator Site 2502 Zagreb
Croatia Investigator Site 2508 Zagreb
Croatia Investigator Site 2509 Zagreb
Czechia Investigator Site 3003 Brno
Czechia Investigator Site 3009 Brno
Czechia Investigator Site 3010 Hradec Králové
Czechia Investigator Site 3006 Jihlava
Czechia Investigator Site 3002 Ostrava-Poruba
Czechia Investigator Site 3007 Pardubice
Czechia Investigator Site 3001 Praha 2
Czechia Investigator Site 3008 Praha 5
Czechia Investigator Site 3004 Teplice
Finland Investigator Site 2212 Tampere
Finland Investigator Site 2202 Turku
France Investigator Site 1713 Bordeaux Cedex
France Investigator Site 1703 Clermont Ferrand Cedex 1
France Investigator Site 1715 Nantes Cedex 1
France Investigator Site 1706 Nice Cedex 1
France Investigator Site 1705 Strasbourg Cedex
Georgia Investigator Site 3902 Tbilisi
Georgia Investigator Site 3903 Tbilisi
Georgia Investigator Site 3904 Tbilisi
Georgia Investigator Site 3905 Tbilisi
Georgia Investigator Site 3906 Tbilisi
Germany Investigator Site 1113 Dresden
Germany Investigator Site 1107 Erfurt
Germany Investigator Site 1109 Leipzig
Germany Investigator Site 1104 Mainz
Germany Investigator Site 1102 Ulm
Greece Investigator Site 1301 Athens
Greece Investigator Site 1303 Athens
Greece Investigator Site 1307 Athens
Hungary Investigator Site 2903 Budapest
Hungary Investigator Site 2905 Budapest
Hungary Investigator Site 2910 Esztergom
Hungary Investigator Site 2902 Gyor
Hungary Investigator Site 2909 Kistarcsa
Israel Investigator Site 4005 Ashkelon
Israel Investigator Site 4004 Haifa
Israel Investigator Site 4006 Jerusalem
Israel Investigator Site 4010 Zfat
Italy Investigator Site 1403 Cefalu
Italy Investigator Site 1409 Genova
Italy Investigator Site 1413 L'Aquila
Italy Investigator Site 1405 Roma
Latvia Investigator Site 3401 Riga
Latvia Investigator Site 3402 Riga
Latvia Investigator Site 3403 Riga
Lithuania Investigator Site 3502 Kaunas
Lithuania Investigator Site 3503 Klaipeda
Lithuania Investigator Site 3504 Siauliai
Mexico Investigator Site 7410 Chihuahua
Mexico Investigator Site 7409 Monterrey
Poland Investigator Site 3219 Bialystok
Poland Investigator Site 3215 Bydgoszcz
Poland Investigator Site 3208 Gdansk
Poland Investigator Site 3203 Katowice
Poland Investigator Site 3217 Katowice
Poland Investigator Site 3205 Konstancin-Jeziorna
Poland Investigator Site 3216 Ksawerow
Poland Investigator Site 3220 Lublin
Poland Investigator Site 3202 Poznan
Poland Investigator Site 3207 Poznan
Poland Investigator Site 3214 Poznan
Poland Investigator Site 3213 Wroclaw
Portugal Investigator Site 1602 Amadora
Portugal Investigator Site 1605 Braga
Portugal Investigator Site 1603 Coimbra
Portugal Investigator Site 1604 Porto
Romania Investigator Site 2804 Bucuresti
Romania Investigator Site 2807 Bucuresti
Romania Investigator Site 2811 Bucuresti
Romania Investigator Site 2802 Timisoara
Russian Federation Investigator Site 3821 Barnaul Altai Krai
Russian Federation Investigator Site 3818 Belgorod
Russian Federation Investigator Site 3837 Bryansk
Russian Federation Investigator Site 3836 Ekaterinburg
Russian Federation Investigator Site 3811 Kazan
Russian Federation Investigator Site 3822 Kemerovo
Russian Federation Investigator Site 3814 Krasnoyarsk
Russian Federation Investigator Site 3823 Kursk
Russian Federation Investigator Site 3803 Moscow
Russian Federation Investigator Site 3810 Moscow
Russian Federation Investigator Site 3831 Moscow
Russian Federation Investigator Site 3840 Moscow
Russian Federation Investigator Site 3802 Nizhniy Novgorod
Russian Federation Investigator Site 3834 Nizhny Novgorod
Russian Federation Investigator Site 3835 Novgorod
Russian Federation Investigator Site 3829 Novosibirsk
Russian Federation Investigator Site 3839 Perm
Russian Federation Investigator Site 3812 Pyatigorsk
Russian Federation Investigator Site 3813 Saint Petersburg
Russian Federation Investigator Site 3805 Samara
Russian Federation Investigator Site 3825 Smolensk
Russian Federation Investigator Site 3807 St. Petersburg
Russian Federation Investigator Site 3808 St. Petersburg
Russian Federation Investigator Site 3815 St. Petersburg
Russian Federation Investigator Site 3833 St. Petersburg
Russian Federation Investigator Site 3801 Tomsk
Russian Federation Investigator Site 3819 Tver
Russian Federation Investigator Site 3842 Yaroslavl
Serbia Investigator Site 2601 Belgrade
Serbia Investigator Site 2606 Belgrade
Serbia Investigator Site 2607 Belgrade
Serbia Investigator Site 2603 Kragujevac
Serbia Investigator Site 2602 Nis
Spain Investigator Site 1504 Barcelona
Spain Investigator Site 1505 Barcelona
Spain Investigator Site 1509 Barcelona
Spain Investigator Site 1502 Madrid
Spain Investigator Site 1501 Malaga
Spain Investigator Site 1506 Sevilla
Sweden Investigator Site 2103 Goteborg
Sweden Investigator Site 2101 Stockholm
Sweden Investigator Site 2110 Stockholm
Turkey Investigator Site 9004 Trabzon
Ukraine Investigator Site 3701 Chernihiv
Ukraine Investigator Site 3714 Chernihiv
Ukraine Investigator Site 3711 Ivano-Frankivsk
Ukraine Investigator Site 3713 Ivano-Frankivsk
Ukraine Investigator Site 3723 Kharkiv
Ukraine Investigator Site 3724 Kharkiv
Ukraine Investigator Site 3716 Kyiv
Ukraine Investigator Site 3715 Lviv
Ukraine Investigator Site 3721 Lviv
Ukraine Investigator Site 3703 Odessa
Ukraine Investigator Site 3717 Poltava
Ukraine Investigator Site 3730 Ternopil
Ukraine Investigator Site 3718 Vinnytsia
Ukraine Investigator Site 3722 Zaporizhia
Ukraine Investigator Site 3725 Zhytomyr
United Kingdom Investigator Site 2015 Glasgow
United Kingdom Investigator Site 2021 Lancashire
United Kingdom Investigator Site 2003 Salford
United States Investigator Site 8045 Carlsbad California
United States Investigator Site 8006 Columbus Ohio
United States Investigator Site 8036 Denver Colorado
United States Investigator Site 8015 Franklin Tennessee
United States Investigator Site 8013 Indianapolis Indiana
United States Investigator Site 8042 Orem Utah
United States Investigator Site 8065 Ormond Beach Florida
United States Investigator Site 8311 Pomona California
United States Investigator Site 8040 Raleigh North Carolina
United States Investigator Site 8018 Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Actelion

Countries where clinical trial is conducted

United States,  Belarus,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Croatia,  Czechia,  Finland,  France,  Georgia,  Germany,  Greece,  Hungary,  Israel,  Italy,  Latvia,  Lithuania,  Mexico,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Spain,  Sweden,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 indicates overall functional impairment assessing Visual,Brain Stem,Pyramidal,Cerebellar,Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS in conjunction with observations and information concerning gait and use of assistance. EDSS is ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10(death due to MS). From randomization to end of study (Week 108)
Secondary Change From Baseline in Fatigue-related Symptoms as Measured by the Symptoms Domain of the Fatigue Symptom and Impact Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS) Score to Week 108 The FSIQ-RMS is a 20-item Patient Reported Outcomes (PRO) measure to evaluate fatigue-related symptoms and the impacts of those symptoms on the lives of people. The FSIQ-RMS symptom domain (FSIQ-RMS-S) consists of seven items assessing fatigue-related symptoms daily with a recall period of 24 hours measured on an 11-point numeric rating scale; the (normalized) symptom domain score ranges from 0 to 100 with a higher score indicating greater fatigue. This domain was completed on 7 consecutive days. A negative change from baseline indicates an improvement in fatigue symptoms. Baseline to Week 108
Secondary Cumulative Number of Combined Unique Active Lesions (CUAL) Per Year From Baseline to Week 108 CUALs was calculated as sum of new Gadolinium-enhanced (Gd+) T1 lesions plus new or enlarging T2 lesions (without double-counting of lesions) from baseline based on the Magnetic resonance imaging (MRI) scans up to Week 108. Average number of lesions per year were reported. Baseline to Week 108
Secondary 12-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS A 12-week CDA was defined as an increase of at least 1.5 in Expanded Disability Status Scale (EDSS) for participants with a baseline EDSS score of 0.0 or an increase of at least 1.0 in EDSS for participants with a baseline EDSS score of 1.0 to 5.0, or an increase of at least 0.5 in EDSS for participants with a baseline EDSS score greater than or equal to (>=) 5.5, which was confirmed after 12 weeks. Baseline EDSS was defined as the last EDSS score recorded prior to randomization. EDSS is an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to MS). Baseline to Week 60 and 108 Weeks
Secondary 24-Week Confirmed Disability Accumulation (CDA) Assessed From Baseline to EOS A 24-week CDA was defined as an increase of at least 1.5 in EDSS for participants with a baseline EDSS score of 0.0 or an increase of at least 1.0 in EDSS for participants with a baseline EDSS score of 1.0 to 5.0, or an increase of at least 0.5 in EDSS for participants with a baseline EDSS score >= 5.5, which was confirmed after 24 weeks. Baseline EDSS was defined as the last EDSS score recorded prior to randomization. The EDSS is an ordinal scale ranging from 0 (normal neurological exam) to 10 (death to MS). Baseline to 60 Weeks and 108 Weeks
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