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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Managed Access Program (MAP) for Patients Diagnosed With Secondary Progressive Multiple Sclerosis With Active Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Expanded Access
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria: 1. 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. 2. 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) 3. Patient is ambulatory, i.e., has an EDSS score of ≤6.5. 4. 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:

Patients eligible for this Treatment Plan must not meet any of the following criteria: 1. Disease exclusions. 1. Relapsing-remitting multiple sclerosis. 2. Primary progressive multiple sclerosis. 3. Secondary progressive multiple sclerosis without active disease. 2. Medical conditions precluding inclusion such as lab abnormalities or underlying diseases. 1. 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) 2. Severe active infections Patients affected by severe infections should only be included after full resolution of the condition. 3. Second-degree AV block Mobitz type II or higher, sick-sinus syndrome, sino-atrial heart block or significant QT prolongation (QTc ≥500 msec). 4. History of cardiac arrest, recurrent syncope, symptomatic bradycardia, severe cerebrovascular disease, uncontrolled hypertension or severe untreated sleep apnea. 5. Significant liver disease. 6. Ongoing macular edema (patients with a history of resolved macular edema are allowed to enter the program) 7. Patients homozygous for CYP2C9*3 (CYP2C9*3*3 genotype) 8. Patients without a health-care professional confirmed history of chickenpox or documentation of a full course of vaccination with varicella vaccine. They have to undergo antibody testing to varicella zoster virus (VZV) before initiating treatment with siponimod. A full course of vaccination for antibody-negative patients with varicella vaccine is required prior to commencing treatment with siponimod. Initiation of treatment with siponimod has be postponed for one month after completion of the vaccination course to allow full effect of vaccination to occur. 9. History of hypersensitivity to any drugs or metabolites of similar chemical classes as siponimod. 3. Prior therapy precluding enrollment: 1. Natalizumab, immunosuppressive/chemotherapeutic medications (e.g. azathioprine, methotrexate) within 6 months prior to enrollment. 2. Rituximab, ofatumumab, ocrelizumab, cladribine, or cyclophosphamide within one year prior to enrollment. 3. Any mitoxantrone during previous two years prior to enrollment or evidence of cardiotoxicity following mitoxantrone or a cumulative life-time dose of more than 60 mg/m2. 4. alemtuzumab, lymphoid irradiation, bone marrow transplantation or other immunosuppressive treatments with effects potentially lasting over 6 months, at any time. 4. Concomitant therapy precluding enrollment: 1. Alemtuzumab, azathioprine, cyclophosphamide, cyclosporine, methotrexate, mitoxantrone, natalizumab, rituximab, ofatumumab, or ocrelizumab as immunosuppressive or immune-modulating therapies. 2. Only during treatment initiation: Class Ia (e.g. quinidine, procainamide), Class III anti-arrhythmic drugs (e.g. amiodarone, sotalol) during treatment initiation. 5. Have any of the following out-of-range laboratory values: 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or gamma-glutamyl transferase (GGT) greater than 5 times the upper limit of normal (ULN) range. 2. White blood cell (WBC) count < 3,500/mm3 (< 3.5 x 109/L) 3. Lymphocyte count < 800/mm3 (< 0.8 x 109/L) 4. Serum potassium > ULN. 6. Participation in a prior investigational study within 30 days prior to enrollment or within five half-lives of the investigational study drug or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. 7. Pregnancy statements and contraception requirements. 1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL). 2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are:
  • - Women whose partners have been sterilized by vasectomy or other means.
  • - Using a highly effective method of birth control for the duration of treatment with siponimod and for at least ten days after stopping treatment with siponimod.
Highly effective method of birth control are such resulting in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs); periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
  • - Total abstinence from female-male intercourse (when this is in line with the preferred and usual lifestyle of the subject, if accepted by local regulation) 8.
Not able to understand and to comply with treatment instructions and requirements.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04540861
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Available
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Novartis Pharmaceuticals

[email protected]

+41613241111

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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