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Secondary Progressive Multiple Sclerosis (SPMS)NCT04593927

Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients

An observational study of Secondary Progressive Multiple Sclerosis (SPMS), run by Novartis Pharmaceuticals at 174 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is a single cohort, central registration system, all-case, open-label, multicenter observational study in patients using Mayzent for the indication of secondary progressive multiple sclerosis. Read more about this study

Who is it for?
Ages Up to 99 years
What is being tested?
Mayzent
How many people
451 participants
Where
174 sitesJapan
Study dates
28 Oct 2020to 30 Aug 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients using Mayzent for the following indication for a specified post-marketing period of time • Indication: prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis By allowing patients who started Mayzent administration before the conclusion of a contract for this study to be included in the study population after the contract, all patients treated with Mayzent will be enrolled in this study.

Who may be able to join

  • Patients prescribed Mayzent for prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis

Who cannot join

  • -

Trial locations and contacts

174 sites in 1 country.

174 sites in 1 country

Japan174 sites

  • Novartis Investigative Site

    Adachi City, Tokyo, 123-0864

  • Novartis Investigative Site

    Adachi-ku, Tokyo, 121-0061

  • Novartis Investigative Site

    Ageo, Saitama, 362-8588

  • Novartis Investigative Site

    Akita, 010-1495

  • Novartis Investigative Site

    Ako, Hyōgo, 678-0239

  • Novartis Investigative Site

    Anjo, Aichi-ken, 446-8602

  • Novartis Investigative Site

    Aomori, 030 8553

  • Novartis Investigative Site

    Asahikawa, Hokkaido, 070-8530

  • Novartis Investigative Site

    Ashigarakami, Kanagawa, 258-0003

  • Novartis Investigative Site

    Atsugi, Kanagawa, 243-0121

  • Novartis Investigative Site

    Awaji, Hyōgo, 672-8501

  • Novartis Investigative Site

    Beppu, Oita Prefecture, 874-0011

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 113 8655

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 113-8431

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8519

  • Novartis Investigative Site

    Chiba, 260 8677

  • Novartis Investigative Site

    Chiisagata, Nagano, 386-0603

  • Novartis Investigative Site

    Edogawa City, Tokyo, 134-0086

  • Novartis Investigative Site

    Fuchū, Tokyo, 183-0042

  • Novartis Investigative Site

    Fuchū, Tokyo, 183-8524

  • Novartis Investigative Site

    Fuji, Shizuoka, 416-0955

  • Novartis Investigative Site

    Fujiidera, Osaka, 583-0014

  • Novartis Investigative Site

    Fukui, 918-8503

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-8582

  • Novartis Investigative Site

    Fukuoka, 810-0022

  • Novartis Investigative Site

    Fukuyama, Hiroshima, 720-0825

  • Novartis Investigative Site

    Gifu, Gifu, 500 8513

  • Novartis Investigative Site

    Gifu, Gifu, 501-1194

  • Novartis Investigative Site

    Gifu, 500-8717

  • Novartis Investigative Site

    Ginowan, Okinawa, 901-2214

  • Novartis Investigative Site

    Hachinohe, Aomori, 039-1104

  • Novartis Investigative Site

    Hachiōji, Tokyo, 192-0032

  • Novartis Investigative Site

    Hachiōji, Tokyo, 193-0944

  • Novartis Investigative Site

    Hakodate, Hokkaido, 041-0821

  • Novartis Investigative Site

    Hamamatsu, Shizuoka, 431-3192

  • Novartis Investigative Site

    Hanamaki, Iwate, 025-0082

  • Novartis Investigative Site

    Hekinan, Aichi-ken, 447-0084

  • Novartis Investigative Site

    Higashiosaka, Osaka, 578-8588

  • Novartis Investigative Site

    Hiratsuka, Kanagawa, 254-0065

  • Novartis Investigative Site

    Hirosaki, Aomori, 036 8563

  • Novartis Investigative Site

    Hiroshima, 730-0004

  • Novartis Investigative Site

    Hiroshima, 730-8518

  • Novartis Investigative Site

    Hiroshima, 734-8551

  • Novartis Investigative Site

    Hitachi, Ibaraki, 317-0077

  • Novartis Investigative Site

    Hitachi-Naka, Ibaraki, 312-0057

  • Novartis Investigative Site

    Ichihara, Chiba, 299-0111

  • Novartis Investigative Site

    Ichikawa, Chiba, 272-8513

  • Novartis Investigative Site

    Ichinomiya, Aichi-ken, 491-0041

  • Novartis Investigative Site

    Ichinoseki, Iwate, 021-0871

  • Novartis Investigative Site

    Iida, Nagano, 395-8502

  • Novartis Investigative Site

    Ina, Nagano, 396-0033

  • Novartis Investigative Site

    Iruma-gun, Saitama, 350-0495

  • Novartis Investigative Site

    Isehara, Kanagawa, 259-1193

  • Novartis Investigative Site

    Isesaki, Gunma, 372-0817

  • Novartis Investigative Site

    Itabashi Ku, Tokyo, 173 8606

  • Novartis Investigative Site

    Itami, Hyōgo, 664-8533

  • Novartis Investigative Site

    Iwamizawa, Hokkaido, 068-0007

  • Novartis Investigative Site

    Izumo, Shimane, 693 8501

  • Novartis Investigative Site

    Izunokuni, Shizuoka, 410-2295

  • Novartis Investigative Site

    Kagoshima, Kagoshima-ken, 890 8520

  • Novartis Investigative Site

    Kagoshima, 890-0008

  • Novartis Investigative Site

    Kagoshima, 890-0067

  • Novartis Investigative Site

    Kamikoshikichō-oshima, Kagoshima-ken, 891-7101

  • Novartis Investigative Site

    Kanazawa, Ishikawa-ken, 920-0853

  • Novartis Investigative Site

    Kariya, Aichi-ken, 448-0852

  • Novartis Investigative Site

    Kashihara, Nara, 634 8522

  • Novartis Investigative Site

    Kasugai, Aichi-ken, 487-0031

  • Novartis Investigative Site

    Kawagoe, Saitama, 350 8550

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 216-8511

  • Novartis Investigative Site

    Kesennuma, Miyagi, 988-0085

  • Novartis Investigative Site

    Kita-gun, Kagawa-ken, 761-0793

  • Novartis Investigative Site

    Kitaazumi, Nagano, 399-8601

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 802-8517

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 806-8501

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 807-8556

  • Novartis Investigative Site

    Kitami, Hokkaido, 090-0837

  • Novartis Investigative Site

    Kobe, Hyōgo, 650-0017

  • Novartis Investigative Site

    Kobe, Hyōgo, 650-0044

  • Novartis Investigative Site

    Kochi, 781-0011

  • Novartis Investigative Site

    Kodaira, Tokyo, 187-8551

  • Novartis Investigative Site

    Koshigaya, Saitama, 343-8555

  • Novartis Investigative Site

    Koshigaya, Saitama, 343-8577

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 860-8556

  • Novartis Investigative Site

    Kumamoto, 862-0970

  • Novartis Investigative Site

    Kurayoshi, Tottori, 682-0863

  • Novartis Investigative Site

    Kure, Hiroshima, 737-0023

  • Novartis Investigative Site

    Kurume, Fukuoka, 830-0011

  • Novartis Investigative Site

    Kushiro, Hokkaido, 085-0052

  • Novartis Investigative Site

    Kyoto, Kyoto, 616-8255

  • Novartis Investigative Site

    Kyoto, 603-8041

  • Novartis Investigative Site

    Kyoto, 616-8144

  • Novartis Investigative Site

    Maebashi, Gunma, 371 8511

  • Novartis Investigative Site

    Maebashi, Gunma, 371-0847

  • Novartis Investigative Site

    Matsumoto, Nagano, 390-8621

  • Novartis Investigative Site

    Matsumoto, Nagano, 390-8648

  • Novartis Investigative Site

    Meguro City, Tokyo, 153-8515

  • Novartis Investigative Site

    Miyakonojō, Miyazaki, 885-0055

  • Novartis Investigative Site

    Muroran, Hokkaido, 050-0082

  • Novartis Investigative Site

    Nagakute, Aichi-ken, 480-1195

  • Novartis Investigative Site

    Nagano, Nagano, 380-8582

  • Novartis Investigative Site

    Nagaoka, Niigata, 940-2085

  • Novartis Investigative Site

    Nagaoka, Niigata, 940-8653

  • Novartis Investigative Site

    Nagasaki, 850-0835

  • Novartis Investigative Site

    Nagasaki, 850-8555

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 451-8511

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 453-0815

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 454-0012

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 455-8530

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 466 8560

  • Novartis Investigative Site

    Nakano City, Tokyo, 164-8607

  • Novartis Investigative Site

    Nankoku, Kochi, 783 8505

  • Novartis Investigative Site

    Niigata, Niigata, 950-1197

  • Novartis Investigative Site

    Niigata, 951 8520

  • Novartis Investigative Site

    Nishinomiya, Hyōgo, 663 8501

  • Novartis Investigative Site

    Ohtsu-city, Shiga, 520-2192

  • Novartis Investigative Site

    Ōita, Oita Prefecture, 870-0192

  • Novartis Investigative Site

    Ōita, 870-8511

  • Novartis Investigative Site

    Okayama, Okayama-ken, 700-8558

  • Novartis Investigative Site

    Okayama, Okayama-ken, 700-8607

  • Novartis Investigative Site

    Ōmihachiman, Shiga, 523-0082

  • Novartis Investigative Site

    Osaka, Osaka, 543-8555

  • Novartis Investigative Site

    Osaka, 545-8586

  • Novartis Investigative Site

    Ōsaka-sayama, Osaka, 589 8511

  • Novartis Investigative Site

    Ōta, Gunma, 373-8585

  • Novartis Investigative Site

    Ōta-ku, Tokyo, 143 8541

  • Novartis Investigative Site

    Ōta-ku, Tokyo, 145-0065

  • Novartis Investigative Site

    Ōta-ku, Tokyo, 146-0092

  • Novartis Investigative Site

    Oyama, Tochigi, 323-0827

  • Novartis Investigative Site

    Rumoi, Hokkaido, 077-0007

  • Novartis Investigative Site

    Saga, Saga-ken, 849-8501

  • Novartis Investigative Site

    Saga, 840-8571

  • Novartis Investigative Site

    Sagamihara, Kanagawa, 252-0375

  • Novartis Investigative Site

    Saitama, 330 8503

  • Novartis Investigative Site

    Sakai, Osaka, 593-8304

  • Novartis Investigative Site

    Sakata, Yamagata, 998-8501

  • Novartis Investigative Site

    Saku, Nagano, 384-0301

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-0807

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8543

  • Novartis Investigative Site

    Sapporo, Hokkaido, 063-0005

  • Novartis Investigative Site

    Sasebo, Nagasaki, 857-8511

  • Novartis Investigative Site

    Sendai, Miyagi, 980 8574

  • Novartis Investigative Site

    Seto, Aichi-ken, 489-8642

  • Novartis Investigative Site

    Shimonoseki, Yamaguchi, 750-0061

  • Novartis Investigative Site

    Shimotsuke, Tochigi, 329-0498

  • Novartis Investigative Site

    Shinagawa-ku, Tokyo, 142-8666

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 162 8666

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 160 8582

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 160-0023

  • Novartis Investigative Site

    Shizuoka, 420-0853

  • Novartis Investigative Site

    Shūnan, Yamaguchi, 745-8522

  • Novartis Investigative Site

    Suita, Osaka, 565 0871

  • Novartis Investigative Site

    Suwa, Nagano, 392-8510

  • Novartis Investigative Site

    Suzuka, Mie-ken, 513-8505

  • Novartis Investigative Site

    Takatsuki, Osaka, 569-8686

  • Novartis Investigative Site

    Tokushima, 770-0852

  • Novartis Investigative Site

    Tokushima, 770-8503

  • Novartis Investigative Site

    Tōon, Ehime, 791-0295

  • Novartis Investigative Site

    Toride, Ibaraki, 302-0022

  • Novartis Investigative Site

    Toyama, Toyama, 930-0194

  • Novartis Investigative Site

    Tsu, Mie-ken, 514-8507

  • Novartis Investigative Site

    Tsubame, Niigata, 959-1228

  • Novartis Investigative Site

    Tsubame, Niigata, 959-1284

  • Novartis Investigative Site

    Tsuchiura, Ibaraki, 300-0028

  • Novartis Investigative Site

    Tsukuba, Ibaraki, 305-8558

  • Novartis Investigative Site

    Tsukuba, Ibaraki, 305-8576

  • Novartis Investigative Site

    Ube, Yamaguchi, 755-8505

  • Novartis Investigative Site

    Usa, Oita Prefecture, 879-0231

  • Novartis Investigative Site

    Wako, Saitama, 351-0102

  • Novartis Investigative Site

    Yachiyo, Chiba, 276-8524

  • Novartis Investigative Site

    Yokohama, Kanagawa, 227-8501

  • Novartis Investigative Site

    Yokohama, Kanagawa, 232 0024

  • Novartis Investigative Site

    Yokohama, Kanagawa, 236-0004

  • Novartis Investigative Site

    Yokosuka, Kanagawa, 238-8558

  • Novartis Investigative Site

    Yufu, Oita Prefecture, 879-5593

Other trials in Japan

About this study

Official title: Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients (Prevention of Relapses and Delay of Progression of Physical Disability in Secondary Progressive Multiple Sclerosis)

This study is a single cohort, central registration system, all-case, open-label, multicenter observational study in patients using Mayzent for the indication of secondary progressive multiple sclerosis.

Read the detailed description

This is a non-interventional study, and as such there is no binding treatment strategy, diagnosis/treatment procedures or visit schedule. The investigator should administer Mayzent as labelled. Routine medical practice will apply to visit frequency and evaluation variables, and only these data will be collected by the sponsor as part of the study procedures. The investigator should record data in the applicable CRFs at every visit if possible.

Being tested
Mayzent
Keywords
Secondary Progressive Multiple Sclerosis, SPMS, Mayzent, Siponimod, Japan
Medical subject headings
Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MayzentDrug

    There is no treatment allocation. Patients administered Mayzent by prescription that have started before inclusion of the patient into the study will be enrolled.

Study groups in NCT04593927
Study groupRoleWhat they receive
MayzentPatients administered Mayzent by prescription
Receives: Drug: Mayzent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions

    A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal.

    An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Mayzent or whose causality is not recorded

    Measured: 24 months

Secondary outcomes (5)

  1. Physician's Global Assessment (PGA) of disease activity

    Secondary Progressive Multiple Sclerosis (SPMS) symptom changes will be assessed an rated as "very much improved", "improved", "unchanged", "worsening" or "not assessable" in comparison with the symptoms at the start of Mayzent administration

    Measured: month 12 and month 24

  2. Changes over time in Expanded Disability Status Scale (EDSS) score

    EDSS assesses disability. An overall score ranging from 0 (normal) to 10 (death due to MS) will be calculated.

    Measured: Baseline, month 3, month 6, month 9, month 12, month 15, month 18, month 21 and month 24

  3. Time to confirmed disability progression continuing for ≥ 3 months from the start of administration as assessed by the EDSS

    Disability progression is defined as an increase of 1.5 points or more in patients with an EDSS score of 0 at baseline, an increase of 1 point or more in patients with an EDSS score of 0.5 to 5 at baseline and an increase of 0.5 points or more in patients with an EDSS score of 5.5 or more at baseline.

    Measured: 24 months

  4. Time to confirmed disability progression continuing for ≥ 6 months from the start of administration as assessed by the EDSS

    Disability progression is defined as an increase of 1.5 points or more in patients with an EDSS score of 0 at baseline, an increase of 1 point or more in patients with an EDSS score of 0.5 to 5 at baseline and an increase of 0.5 points or more in patients with an EDSS score of 5.5 or more at baseline.

    Measured: 24 months

  5. Annual relapse rate

    Annual relapse rate will be calculated

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2020
  2. Study start28 Oct 2020
  3. Primary completion30 Aug 2023
  4. Study completion30 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04593927
Sponsor's protocol ID
CBAF312A1401
Status last verified
Feb 2024
First submitted
14 Oct 2020
Last updated
12 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Secondary Progressive Multiple Sclerosis (SPMS), run by Novartis Pharmaceuticals at 174 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 174 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Reactions (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04593927.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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