Clinical trial NCT01093326: Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2010-03-25
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Annualized Relapse Rate (ARR) of Confirmed Relapses
timeFrame: From ponesimod start date up to the end of Analysis Period (AP) 3. The actual time varied for each participant and could be up to 13.3 years
measure: Time to First Confirmed Relapse
timeFrame: From ponesimod start date up to the end of Analysis Period (AP) 3. The actual time varied for each participant and could be up to 13.3 years
measure: Time to 24 Weeks Confirmed Disability Progression
timeFrame: From ponesimod baseline up to the end of Analysis Period (AP) 3. The actual time varied for each participant and could be up to 13.3 years
Secondary outcomes:
Other outcomes:
measure: Number of Participants With at Least One Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: From ponesimod start date up to the end of study treatment + 15 Days. The actual time of observation varied for each participant and could be up to 12.97 years + 15 days
Locations:
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Palo Alto
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Venice
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Kansas City
country: United States
state: Kansas
city: Lenexa
country: United States
state: Kansas
city: Latham
country: United States
state: New York
city: Schenectady
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Burlington
country: United States
state: Vermont
city: Kirkland
country: United States
state: Washington
city: Vienna
country: Austria
city: Sofia
country: Bulgaria
city: Ottawa
country: Canada
state: Ontario
city: Brno
country: Czechia
city: Jihlava
country: Czechia
city: Olomouc
country: Czechia
city: Ostrava-Poruba
country: Czechia
city: Praha 2
country: Czechia
city: Teplice
country: Czechia
city: Helsinki
country: Finland
city: Hyvinkää
country: Finland
city: Tampere
country: Finland
city: Turku
country: Finland
city: Montpellier Cedex 5
country: France
city: Berlin
country: Germany
city: Essen
country: Germany
city: Ulm
country: Germany
city: Budapest
country: Hungary
city: Esztergom
country: Hungary
city: Győr
country: Hungary
city: Miskolc
country: Hungary
city: Tel-Hashomer
country: Israel
city: Zerifin
country: Israel
city: Breda
country: Netherlands
city: Katowice
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Cluj-Napoca
country: Romania
city: Timisoara
country: Romania
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhniy Novgorod
country: Russian Federation
city: Pyatigorsk
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Saratov
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: UFA
country: Russian Federation
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Nis
country: Serbia
city: Majadahonda
country: Spain
city: Malaga
country: Spain
city: Sevilla
country: Spain
city: Göteborg
country: Sweden
city: Stockholm
country: Sweden
city: Umeå
country: Sweden
city: Lugano
country: Switzerland
city: Chernihiv
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Kyiv
country: Ukraine
city: Odesa
country: Ukraine
city: Bristol
country: United Kingdom
city: London
country: United Kingdom
city: Plymouth
country: United Kingdom
Study officials:
References: