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

Multiple Sclerosis Clinical Trial

— EXCHANGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03623243
• Other study ID #: CBAF312AUS02
• Status: Completed
• Phase: Phase 3
• Start date: February 14, 2019
• Est. completion date: July 6, 2022

Study information

• Verified date: June 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: July 6, 2022
• Est. primary completion date: July 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Siponimod
Siponimod 2mg tablets taken once daily

Locations

Country	Name	City	State
Puerto Rico	Novartis Investigative Site	Guaynabo
United States	Abington Neurological Associates, Ltd	Abington	Pennsylvania
United States	Novartis Investigative Site	Asheville	North Carolina
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Boca Raton	Florida
United States	Novartis Investigative Site	Bradenton	Florida
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	MS & Neuromuscular Center of Excellence	Clearwater	Florida
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Clinton Township	Michigan
United States	Novartis Investigative Site	Colorado Springs	Colorado
United States	Novartis Investigative Site	Cordova	Tennessee
United States	Novartis Investigative Site	Cullman	Alabama
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Falls Church	Virginia
United States	Novartis Investigative Site	Flossmoor	Illinois
United States	Novartis Investigative Site	Fort Collins	Colorado
United States	Novartis Investigative Site	Fresno	California
United States	Novartis Investigative Site	Fullerton	California
United States	Novartis Investigative Site	Greensboro	North Carolina
United States	Novartis Investigative Site	Greer	South Carolina
United States	Novartis Investigative Site	Hackensack	New Jersey
United States	Alabama Neurology Associates	Homewood	Alabama
United States	Novartis Investigative Site	Indian Land	South Carolina
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Irvine	California
United States	Novartis Investigative Site	Johnson City	Tennessee
United States	Novartis Investigative Site	Kirkland	Washington
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Lexington	Kentucky
United States	Novartis Investigative Site	Lexington	Kentucky
United States	Novartis Investigative Site	Lexington	Kentucky
United States	Novartis Investigative Site	Maitland	Florida
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Ocala	Florida
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Oldsmar	Florida
United States	Novartis Investigative Site	Orlando	Florida
United States	Novartis Investigative Site	Ormond Beach	Florida
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigative Site	Rockville	Maryland
United States	Novartis Investigative Site	Round Rock	Texas
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	Sarasota	Florida
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Spokane	Washington
United States	Novartis Investigative Site	Sunrise	Florida
United States	Novartis Investigative Site	Tacoma	Washington
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Vero Beach	Florida
United States	Novartis Investigative Site	Waukesha	Wisconsin
United States	Novartis Investigative Site	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) Related to Study Drug During the Treatment Period	An Adverse Event (AE) is any untoward medical occurrence in a participant that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as the AEs started after the first dose of siponimod to 30 days after the date of the last actual administration, or events present prior to start of treatment but which increased in severity. TEAEs suspected to be related to study drug are reported.	From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)
Secondary	Number of Participants With at Least One Adverse Event (AE)	AE is any untoward sign or symptom that occurs during the study treatment plus 30 days post treatment.	From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)
Secondary	Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9)	TSQM-9 measures participant satisfaction with the medication in 3 domains: Effectiveness, convenience, and global satisfaction. The scores were computed by adding items for each domain, i.e., 1 to 3 for effectiveness, 4 to 6 for convenience, and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) x 3 items = 18 for effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement.	Baseline up to Day 168
Secondary	Change in Heart Rate From Baseline to 6 Hours After First Treatment	Heart rate was evaluated from the time of initial dose intake until 6 hours post dose intake via heart monitor.	From the first dose up to 6 hours
Secondary	Number of Participants With at Least One Hospitalization During the Treatment		From first dose of study drug up to last dose of study drug (up to 6 months)
Secondary	Patient Retention Reported as Number of Participants Who Completed the Study	Patient retention was assessed over the study period.	From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)