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EUCTR2012-003056-36
Iscrizione alternativa con informazioni locali ulteriori: 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

Base di dati: WHO (Importata da 29.11.2020)
Cambiato: 29.11.2020
Categoria di malattie:

Health conditions (Fonte di dati: 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 (Fonte di dati: 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 (Fonte di dati: 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

Altri dati sulla sperimentazione nel registro primario dell’OMS

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

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

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

Altre informazioni sulla sperimentazione

Data di registrazione della sperimentazione

29.10.2012

Inserimento del primo partecipante

21.12.2012

Stato di reclutamento

Authorised-recruitment may be ongoing or finished

Titolo scientifico (Fonte di dati: 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

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional clinical trial of medicinal product

Disegno della sperimentazione (Fonte di dati: 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

Fase (Fonte di dati: WHO)

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

Punti finali primari (Fonte di dati: 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

Punti finali secondari (Fonte di dati: 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

Contatto per informazioni (Fonte di dati: WHO)

Novartis Pharma Services AG

Risultati della sperimentazione (Fonte di dati: WHO)

Sintesi dei risultati

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

Collegamento ai risultati nel registro primario

ancora nessuna informazione disponibile

Informazioni sulla disponibilità dei dati dei singoli partecipanti

ancora nessuna informazione disponibile

Siti di esecuzione della sperimentazione

Paesi di esecuzione (Fonte di dati: 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

Contatto per maggiori informazioni sulla sperimentazione

Contatto per informazioni generali (Fonte di dati: WHO)

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

Contatto per informazioni scientifiche (Fonte di dati: WHO)

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

Responsabile della sperimentazione

Sponsor principale (Fonte di dati: WHO)

Novartis Pharma Services AG

Altri numeri di identificazione delle sperimentazioni

Secondary ID (Fonte di dati: WHO)

CBAF312A2304
NCT01665144
2012-003056-36-HU