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EUCTR2012-003056-36
Alternativer Eintrag mit zusätzlichen lokalen Informationen: NCT01665144

Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312

Datenbasis: WHO (Import vom 29.11.2020)
Geändert: 29.11.2020
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Secondary progressive multiple sclerosis
MedDRA version: 21.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Interventions (Datenquelle: WHO)


Product Name: Siponimod 2 mg tablet
Product Code: BAF312A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: Siponimod 1 mg tablet
Product Code: BAF312A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: Siponimod 0.5 mg tablet
Product Code: BAF312A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: Siponimod 0.25 mg tablet
Product Code: BAF312A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Inclusion/Exclusion Criteria (Datenquelle: WHO)

Inclusion criteria:
Prior history of relapsing remitting MS

Secondary progressive multiple sclerosis (SPMS) defined as progressive increase of disability in at least 6 months

EDSS score of 3.0 to 6.5

No relapse or corticosteroid treatment within 3 months

Other protocol-defined inclusion criteria may apply

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1530
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Women of child bearing potential must use reliable forms of contraception.

Diagnosis of Macular edema during screening period

Any medically unstable condition determined by investigator

Unable to undergo MRI scans

Hypersensitivity to any study drugs or drugs of similar class

Other protocol-defined exclusion criteria may apply

Weitere Angaben zur Studie im WHO-Primärregister

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003056-36

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2012-003056-36-LT

Weitere Informationen zur Studie

Registrationsdatum der Studie

29.10.2012

Einschluss der ersten teilnehmenden Person

21.12.2012

Rekrutierungsstatus

Authorised-recruitment may be ongoing or finished

Wissenschaftlicher Titel (Datenquelle: WHO)

A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312 - EXPAND

Studientyp (Datenquelle: WHO)

Interventional clinical trial of medicinal product

Design der Studie (Datenquelle: WHO)

Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2

Phase (Datenquelle: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no

Primäre Endpunkte (Datenquelle: WHO)

Main Objective: Primary objective (Core part): To demonstrate the efficacy of Siponimod (BAF312) relative to placebo in delaying the time to 3-month confirmed disability progression in patients with secondary progressive multiple sclerosis (SPMS) as measured by expanded disability status scale (EDSS)

;Secondary Objective: First key secondary objective (Core part): To demonstrate the efficacy of Siponimod relative to placebo in delaying the time to 3-month confirmed worsening of at least 20% from Baseline in the timed 25-foot walk test (T25W)
Second key secondary objective (Core part): To demonstrate the efficacy of Siponimod relative to placebo in reducing the increase in T2 lesion volume from Baseline

For further secondary objectives please see protocol

Extension Part: To evaluate the long-term safety, tolerability and efficacy of BAF312
;Primary end point(s): Core part: The delay in time to 3-month confirmed disability progression by Siponimod (BAF312) relative to placebo as measured by expanded disability status scale (EDSS)

Confirmed disability is defined as an increase of score of 1 point in patients with baseline score of 3.0-5.0 and 0.5 point increase with baseline score of 5.5 to 6.5.;Timepoint(s) of evaluation of this end point: baseline, every three months up to the maximum of 3 years

Sekundäre Endpunkte (Datenquelle: WHO)

Secondary end point(s): Core part: The first key secondary endpoint is the delay in time to 3-month confirmed worsening of at least 20% from Baseline in the timed 25-foot walk test (T25W) by Siponimod (BAF312) compared to placebo.

The second key secondary endpoint is the efficacy of Siponimod (BAF312) relative to placebo in reducing the increase in T2 lesion volume from Baseline.

For further secondary endpoints please see protocol.;Timepoint(s) of evaluation of this end point: 1) baseline, every three months up to the maximum of 3 years
2) baseline, every year up to the maximum of 3 years

Kontakt für Auskünfte (Datenquelle: WHO)

Novartis Pharma Services AG

Ergebnisse der Studie (Datenquelle: WHO)

Zusammenfassung der Ergebnisse

A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis followed by extended treatment with open-label BAF312

Link zu den Ergebnissen im Primärregister

noch keine Angaben verfügbar

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

noch keine Angaben verfügbar

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Czechia, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Clinical Trial Information Desk
Upes str. 19
Novartis Pharma Services Inc. Representative Office
+3705269 1650
DRA.Lithuania@novartis.com

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Clinical Trial Information Desk
Upes str. 19
Novartis Pharma Services Inc. Representative Office
+3705269 1650
DRA.Lithuania@novartis.com

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

Novartis Pharma Services AG

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

CBAF312A2304
NCT01665144
2012-003056-36-HU