Managed Access Program (MAP) for Patients Diagnosed With Secondary Progressive Multiple Sclerosis… (NCT04540861) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
Managed Access Program (MAP) for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With Active Disease
Plain-language summary
The purpose of this MAP Cohort Treatment Plan is to allow access to siponimod for eligible patients diagnosed with Secondary Progressive Multiple Sclerosis with active disease.
The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.
The requesting Treating Physician should submit a request for access to the drug (often referred to as Compassionate Use) to Novartis which will be reviewed and assessed by the medical team experienced with the drug and indication.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult patients who are able to provide written informed consent and have done so Note: proof of efficacy in the Phase III EXPAND study (Kappos et al 2018) has been obtained in patients who were aged 18 to 61 years (inclusive) at screening
. Diagnosis of SPMS with active disease. The SPMS diagnosis must follow an initial relapsing-remitting disease course of multiple sclerosis (MS) and align with the diagnostic criteria published (Lublin and Reingold 1996, Rovaris et al 2006, Lublin et al 2014)
. Patient is ambulatory, i.e., has an EDSS score of ≤6.5
. Patient has no comparable or satisfactory alternative therapy available for treatment of SPMS Written patient informed consent must be obtained prior to start of treatment. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
Exclusion criteria
. Disease exclusions
. Relapsing-remitting multiple sclerosis
. Primary progressive multiple sclerosis
. Secondary progressive multiple sclerosis without active disease
. Medical conditions precluding inclusion such as lab abnormalities or underlying diseases
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients with an active or stable but treated chronic disease of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug-induced immune deficiency)
. Severe active infections Patients affected by severe infections should only be included after full resolution of the condition
. Second-degree AV block Mobitz type II or higher, sick-sinus syndrome, sino-atrial heart block or significant QT prolongation (QTc ≥500 msec).