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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 July 2024 |
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Main ID: |
NCT03623243 |
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Date of registration:
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07/08/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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 |
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Scientific title:
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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 |
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Date of first enrolment:
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February 14, 2019 |
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Target sample size:
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185 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03623243 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Puerto Rico
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Advancing Multiple Sclerosis
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Multiple Sclerosis
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Relapsing Multiple Sclerosis
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Intervention(s)
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Drug: Siponimod
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Primary Outcome(s)
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Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) Related to Study Drug During the Treatment Period
[Time Frame: From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)]
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Secondary Outcome(s)
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Number of Participants With at Least One Hospitalization During the Treatment
[Time Frame: From first dose of study drug up to last dose of study drug (up to 6 months)]
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Patient Retention Reported as Number of Participants Who Completed the Study
[Time Frame: From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)]
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Change in Heart Rate From Baseline to 6 Hours After First Treatment
[Time Frame: From the first dose up to 6 hours]
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Number of Participants With at Least One Adverse Event (AE)
[Time Frame: From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)]
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Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9)
[Time Frame: Baseline up to Day 168]
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Secondary ID(s)
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CBAF312AUS02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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