Clinical trial NCT03623243: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Relapsing Multiple Sclerosis
Advancing Multiple Sclerosis
Keywords: Multiple sclerosis
Relapsing multiple sclerosis
Advancing multiple sclerosis
conversion
siponimod
adult
BAF312
disease modifying therapies
cognitive assessment
open-label
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2018-08-09
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label single arm study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) Related to Study Drug During the Treatment Period
timeFrame: From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)
Secondary outcomes:
measure: Number of Participants With at Least One Adverse Event (AE)
timeFrame: From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)
measure: Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9)
timeFrame: Baseline up to Day 168
measure: Change in Heart Rate From Baseline to 6 Hours After First Treatment
timeFrame: From the first dose up to 6 hours
measure: Number of Participants With at Least One Hospitalization During the Treatment
timeFrame: From first dose of study drug up to last dose of study drug (up to 6 months)
measure: Patient Retention Reported as Number of Participants Who Completed the Study
timeFrame: From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Cullman
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Homewood
country: United States
facility: Alabama Neurology Associates
state: Alabama
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Fresno
country: United States
facility: Novartis Investigative Site
state: California
city: Fullerton
country: United States
facility: Novartis Investigative Site
state: California
city: Irvine
country: United States
facility: Novartis Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Fort Collins
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Boca Raton
country: United States
facility: Novartis Investigative Site
state: Florida
city: Bradenton
country: United States
facility: Novartis Investigative Site
state: Florida
city: Clearwater
country: United States
facility: MS & Neuromuscular Center of Excellence
state: Florida
city: Maitland
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Ocala
country: United States
facility: Novartis Investigative Site
state: Florida
city: Oldsmar
country: United States
facility: Novartis Investigative Site
state: Florida
city: Orlando
country: United States
facility: Novartis Investigative Site
state: Florida
city: Ormond Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Sarasota
country: United States
facility: Novartis Investigative Site
state: Florida
city: Sunrise
country: United States
facility: Novartis Investigative Site
state: Florida
city: Tampa
country: United States
facility: Novartis Investigative Site
state: Florida
city: Vero Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Flossmoor
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Indianapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Lexington
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Lexington
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Lexington
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Rockville
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Clinton Township
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Hackensack
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Asheville
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Greensboro
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Raleigh
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Abington
country: United States
facility: Abington Neurological Associates, Ltd
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Willow Grove
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Greer
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Indian Land
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Cordova
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Johnson City
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Round Rock
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Falls Church
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Kirkland
country: United States
facility: Novartis Investigative Site
state: Washington
city: Seattle
country: United States
facility: Novartis Investigative Site
state: Washington
city: Spokane
country: United States
facility: Novartis Investigative Site
state: Washington
city: Tacoma
country: United States
facility: Novartis Investigative Site
state: Washington
city: Waukesha
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Guaynabo
country: Puerto Rico
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: