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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01665144




Registration number
NCT01665144
Ethics application status
Date submitted
3/08/2012
Date registered
15/08/2012
Date last updated
5/06/2024

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
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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
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Bristol
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Leeds
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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
Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment
duration in patients with secondary progressive multiple sclerosis (Core Part) followed by
extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability
and efficacy (Extension Part).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01665144
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