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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01665144




Registration number
NCT01665144
Ethics application status
Date submitted
3/08/2012
Date registered
15/08/2012

Titles & IDs
Public title
Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
Scientific title
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.
Secondary ID [1] 0 0
2012-003056-36
Secondary ID [2] 0 0
CBAF312A2304
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Secondary Progressive Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BAF312
Treatment: Drugs - Placebo

Experimental: Siponimod (BAF312) - Participants started on Day 1 and were uptitrated from 0.25 mg to 2 mg of BAF312 orally over a period of 6 days. After Day 7, participants continued on the treatment epoch for 3 months. During the Core Part of the study, participants participated in a maximum of 3 epochs. Following the Core Part, eligible patients enter the Extension Part during which all receive open-label BAF312.

Placebo comparator: Placebo - Matching placebo to BAF312 was administered orally during the Core Part of the trial. Following the Core Part, eligible participants enter the Extension Part during which all receive open-label BAF312.


Treatment: Drugs: BAF312
0.25, 0.5, 1, and 2 mg film-coated tablets

Treatment: Drugs: Placebo
Film-coated tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With 3-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)
Timepoint [1] 0 0
Baseline, every 3 month up to the maximum of approximately 3 years
Secondary outcome [1] 0 0
Percentage of Participants With 3-month Confirmed Worsening in T25W of at Least 20% From Baseline
Timepoint [1] 0 0
Baseline, every 3 months up to the maximum of approximately 3 years
Secondary outcome [2] 0 0
Change From Baseline in T2 Lesion Volume
Timepoint [2] 0 0
Baseline, Month 12 and Month 24
Secondary outcome [3] 0 0
Percentage of Participants With 6-month Confirmed Disability Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)
Timepoint [3] 0 0
Baseline, every 3 months up to the maximum of approximately 3 years
Secondary outcome [4] 0 0
Annualized Relapse Rate (ARR) for Confirmed Relapses
Timepoint [4] 0 0
Up to maximum approximately 3 years
Secondary outcome [5] 0 0
Percentage of Participants With First Relapse Events as Measured by Time to First Confirmed Relapse
Timepoint [5] 0 0
Up to maximum approximately 3 years
Secondary outcome [6] 0 0
Percentage of Patients With Relapse (Confirmed Relapse and Any Relapse)
Timepoint [6] 0 0
Up to maximum approximately 3 years
Secondary outcome [7] 0 0
Change From Baseline in MSWS-12 Converted Score
Timepoint [7] 0 0
Baseline, Month 12 and Month 24
Secondary outcome [8] 0 0
Number of T1 Gd-enhancing Lesions Per Patient Per Scan
Timepoint [8] 0 0
Baseline, Month 12 and Month 24
Secondary outcome [9] 0 0
Number of New or Enlarging T2 Lesions Per Patient Per Year
Timepoint [9] 0 0
Baseline, Month 12 and Month 24
Secondary outcome [10] 0 0
Percent Brain Volume Change (PBVC) Relative to Baseline
Timepoint [10] 0 0
Baseline, Month 12 and Month 24
Secondary outcome [11] 0 0
Number of Participants With 3-month CDP Events as Measured by EDSS in the Subgroup of SPMS Patients With/Without Superimposed Relapses
Timepoint [11] 0 0
Baseline, every 3 months up to the maximum of approximately 3 years
Secondary outcome [12] 0 0
Number of Participants With 3-month CDP Events as Measured by EDSS in the Subgroup of Rapidly and Not Rapidly Evolving Patients
Timepoint [12] 0 0
Baseline, every 3 months up to the maximum of approximately 3 years
Secondary outcome [13] 0 0
Number of Participants With 3-month CDP Events as Measured by EDSS in the Subgroup of Patients With and Without Moderate/Severe Disease Course
Timepoint [13] 0 0
Baseline, every 3 months up to the maximum of approximately 3 years

Eligibility
Key inclusion criteria
* Prior history of relapsing remitting MS
* SPMS defined as progressive increase of disability over at least 6 months
* EDSS score of 3.0 to 6.5
* No relapse of corticosteroid treatment within 3 months
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2023
Sample size
Target
Accrual to date
Final
1651
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Camperdown
Recruitment hospital [2] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [3] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [4] 0 0
Novartis Investigative Site - Heidelberg
Recruitment hospital [5] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
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TUR
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Samsun
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Trabzon
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United Kingdom
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Manchester
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Oxfordshire
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South Yorkshire
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Bristol
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Glasgow
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Leeds
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Leicester
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London
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Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Locations: central Contact Info Novartis.email@novartis.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01665144