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Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients. (EXCHANGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03623243
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : December 14, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE August 7, 2018
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date December 14, 2022
Actual Study Start Date  ICMJE February 14, 2019
Actual Primary Completion Date July 6, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2020)
Number of patients with treatment emergent adverse events [ Time Frame: Baseline up to 6 months ]
Adverse events considered to be drug related will be collected to assess safety and tolerability at scheduled visits after converting from disease modifying therapies
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
Number of patients with adverse events [ Time Frame: 6 months ]
safety and tolerability after converting from DMTs.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2022)
  • Number of patients satisfied with treatment as measured by Treatment Satisfaction Questionnaire for Medication [ Time Frame: Baseline up to 6 months ]
    TSQM9 - Treatment Satisfaction Questionnaire for Medication: measures patient satisfaction with the medication in 3 domains: effectiveness, convenience, and global satisfaction. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain.
  • Change in Heart Rate from baseline [ Time Frame: Baseline to 6 hours post initial treatment ]
    Heart rate will be evaluated from the time of initial dose intake until 6 hours post dose intake via heart monitor
  • Treatment persistence with Siponimod [ Time Frame: Baseline up to 6 months ]
    Patient retention will be assessed over the study period. Treatment compliance is defined as being 80% adherent and will be assessed via drug accountability performed at the site.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • Number of patients satisfied with treatment [ Time Frame: 6 months ]
    patient satisfaction
  • Adherence [ Time Frame: 6 months ]
    percent of patients who adhere to therapy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients.
Official Title  ICMJE Exploring the Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb Study
Brief Summary To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
Detailed Description This is a 6-month, open-label, multi-center, single arm design, including advancing RMS patients, evaluating the overall safety and tolerability profile of converting from oral, injectable or infusion RMS DMTs to oral siponimod.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open-label single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Multiple Sclerosis
  • Relapsing Multiple Sclerosis
  • Advancing Multiple Sclerosis
Intervention  ICMJE Drug: Siponimod
Siponimod 2mg tablets taken once daily
Other Name: BAF312
Study Arms  ICMJE Experimental: Siponimod 2 mg
Siponimod 2mg tablets taken once daily after a 5 day titration
Intervention: Drug: Siponimod
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2022)
187
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2018)
300
Actual Study Completion Date  ICMJE July 6, 2022
Actual Primary Completion Date July 6, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Signed informed consent.
  2. Male or female aged 18 to 65 years (inclusive).
  3. Patients with advancing RMS as defined by the principal investigator.
  4. Prior history of relapsing MS (RMS), with or without progressive features, according to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013).
  5. EDSS score of >/= 2.0 to 6.5 (inclusive).
  6. Having been continuously treated with RMS Disease Modifying Therapies.

Key Exclusion criteria:

  1. Pregnant or nursing (lactating) women.
  2. Patients with any medically unstable condition as determined by the investigator.
  3. Certain cardiac risk factors defined in the protocol
  4. History of hypersensitivity to the study drug or to drugs of similar chemical classes.

Other protocol-defined inclusion/exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03623243
Other Study ID Numbers  ICMJE CBAF312AUS02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

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

Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP