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To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Siponimod | Experimental | Participants will receive titrated doses of siponimod tablets, orally, once daily of 0.25 mg on Day 2, 0.5 mg on Day 3, 0.75 mg on Day 4, 1.25 mg on Day 5, and maintenance dose of siponimod 2.0 mg tablets, orally, once daily from Day 6 up to 6 months. As of protocol amendment 3, participants entering the trial converting from fingolimod will start directly with 2 mg dose of siponimod. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siponimod | Drug | Siponimod 2mg tablets taken once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) |
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Key Inclusion Criteria:
Key Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35209 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40248858 | Derived | Fox RJ, Cohan S, Mao-Draayer Y, Weinstock-Guttman B, Cruz LA, Arnould S, Cox GM, Bar-Or A. Safety and tolerability of conversion to siponimod from other disease-modifying therapies in patients with advancing forms of relapsing MS: Results from the EXCHANGE study. Mult Scler. 2025 May;31(6):706-718. doi: 10.1177/13524585251330085. Epub 2025 Apr 18. |
| Label | URL |
|---|---|
| Patient Lay Trial Summary | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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A total of 342 participants were screened of which 185 participants were enrolled to receive siponimod.
Participants were enrolled at study sites in the United States from 14 February 2019 to 06 July 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Siponimod | Participants received titrated doses of siponimod tablets, orally, once daily of 0.25 mg on Day 2, 0.5 mg on Day 3, 0.75 mg on Day 4, 1.25 mg on Day 5, and maintenance dose of siponimod 2.0 mg tablets, orally, once daily from Day 6 up to 6 months. As of protocol amendment 3, participants entering the trial converting from fingolimod started directly with 2 mg dose of siponimod. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 27, 2021 | May 25, 2023 |
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Open-label single arm study
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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 |
| 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 |
| 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) |
| 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) |
| Cullman |
| Alabama |
| 35058 |
| United States |
| Alabama Neurology Associates | Homewood | Alabama | 35209 | United States |
| Novartis Investigative Site | Tucson | Arizona | 85718 | United States |
| Novartis Investigative Site | Fresno | California | 93710 | United States |
| Novartis Investigative Site | Fullerton | California | 92835 | United States |
| Novartis Investigative Site | Irvine | California | 92617 | United States |
| Novartis Investigative Site | Colorado Springs | Colorado | 80907 | United States |
| Novartis Investigative Site | Denver | Colorado | 80209 | United States |
| Novartis Investigative Site | Fort Collins | Colorado | 80528 | United States |
| Novartis Investigative Site | Boca Raton | Florida | 33487 | United States |
| Novartis Investigative Site | Bradenton | Florida | 34205 | United States |
| MS & Neuromuscular Center of Excellence | Clearwater | Florida | 33761 | United States |
| Novartis Investigative Site | Maitland | Florida | 32751 | United States |
| Novartis Investigative Site | Miami | Florida | 33136 | United States |
| Novartis Investigative Site | Ocala | Florida | 34471 | United States |
| Novartis Investigative Site | Oldsmar | Florida | 34677 | United States |
| Novartis Investigative Site | Orlando | Florida | 32806 | United States |
| Novartis Investigative Site | Ormond Beach | Florida | 32174 | United States |
| Novartis Investigative Site | Sarasota | Florida | 34243 | United States |
| Novartis Investigative Site | Sunrise | Florida | 33351 | United States |
| Novartis Investigative Site | Tampa | Florida | 33612 | United States |
| Novartis Investigative Site | Vero Beach | Florida | 32960 | United States |
| Novartis Investigative Site | Flossmoor | Illinois | 60422 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46256 | United States |
| Novartis Investigative Site | Lexington | Kentucky | 40503 | United States |
| Novartis Investigative Site | Lexington | Kentucky | 40509 | United States |
| Novartis Investigative Site | Lexington | Kentucky | 40513 | United States |
| Novartis Investigative Site | Rockville | Maryland | 20854 | United States |
| Novartis Investigative Site | Clinton Township | Michigan | 48035 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63110 | United States |
| Novartis Investigative Site | Las Vegas | Nevada | 89128 | United States |
| Novartis Investigative Site | Hackensack | New Jersey | 07601 | United States |
| Novartis Investigative Site | Asheville | North Carolina | 28806 | United States |
| Novartis Investigative Site | Greensboro | North Carolina | 27405 | United States |
| Novartis Investigative Site | Raleigh | North Carolina | 27607 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45219 | United States |
| Novartis Investigative Site | Cleveland | Ohio | 44106-5028 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73104 | United States |
| Abington Neurological Associates, Ltd | Abington | Pennsylvania | 19001 | United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19141 | United States |
| Novartis Investigative Site | Willow Grove | Pennsylvania | 19090 | United States |
| Novartis Investigative Site | Greer | South Carolina | 29650 | United States |
| Novartis Investigative Site | Old Point Station | South Carolina | 29707 | United States |
| Novartis Investigative Site | Cordova | Tennessee | 38018 | United States |
| Novartis Investigative Site | Johnson City | Tennessee | 37604 | United States |
| Novartis Investigative Site | Round Rock | Texas | 78681 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78258 | United States |
| Novartis Investigative Site | Falls Church | Virginia | 22043 | United States |
| Novartis Investigative Site | Kirkland | Washington | 98034 | United States |
| Novartis Investigative Site | Seattle | Washington | 98122 | United States |
| Novartis Investigative Site | Spokane | Washington | 99202 | United States |
| Novartis Investigative Site | Tacoma | Washington | 98405 | United States |
| Novartis Investigative Site | Waukesha | Wisconsin | 53188 | United States |
| Novartis Investigative Site | Guaynabo | 00968 | Puerto Rico |
| Safety Set | Safety set included all participants who received at least one dose of study treatment. |
|
| COMPLETED |
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| NOT COMPLETED |
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Safety set included all participants who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Siponimod | Participants received titrated doses of siponimod tablets, orally, once daily of 0.25 mg on Day 2, 0.5 mg on Day 3, 0.75 mg on Day 4, 1.25 mg on Day 5, and maintenance dose of siponimod 2.0 mg tablets, orally, once daily from Day 6 up to 6 months. As of protocol amendment 3, participants entering the trial converting from fingolimod started directly with 2 mg dose of siponimod. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety set included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | 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. | Safety set included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | 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. | Safety set included all participants who received at least one dose of study treatment. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. | Posted | Mean | Standard Deviation | score on a scale | 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. | Safety set included all participants who received at least one dose of study treatment. | Posted | Mean | Standard Deviation | beats per minute (bpm) | From the first dose up to 6 hours |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With at Least One Hospitalization During the Treatment | Safety set included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | 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. | Safety set included all participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study drug up to 30 days after last dose of study drug (up to 7 months) |
|
|
From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)
Safety set included all participants who received at least one dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Siponimod | Participants received titrated doses of siponimod tablets, orally, once daily of 0.25 mg on Day 2, 0.5 mg on Day 3, 0.75 mg on Day 4, 1.25 mg on Day 5, and maintenance dose of siponimod 2.0 mg tablets, orally, once daily from Day 6 up to 6 months. As of protocol amendment 3, participants entering the trial converting from fingolimod started directly with 2 mg dose of siponimod. | 0 | 185 | 9 | 185 | 63 | 185 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory fume inhalation disorder | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | +1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2022 | May 25, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C578989 | siponimod |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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