Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)

A Phase 2 study testing FTY720 in people with Multiple Sclerosis, run by Novartis at 18 sites in Japan.

Completed

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

Trial summary

To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese patients with relapsing multiple sclerosis (MS) Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Multiple Sclerosis
What is being tested?: FTY720
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 171 participants
Where: 18 sitesJapan
Study dates: Sep 2007to Feb 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male and female patients aged 18-60
Patients with a diagnosis of multiple sclerosis

Who cannot join

Patients with a history or presence of chronic disease of the immune system other than MS
Patients with a history or presence of malignancy, pulmonary or heart disease, etc.
Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

Japan18 sites

Novartis Investigative Site
Chiba, 276-8524
Novartis Investigative Site
Ehime, 791-0295
Novartis Investigative Site
Fukuoka, 807-8555
Novartis Investigative Site
Gunma, 371-8511
Novartis Investigative Site
Hyōgo, 650-0017
Novartis Investigative Site
Ibaraki, 305-8576
Novartis Investigative Site
Kanagawa, 259-1193
Novartis Investigative Site
Kyoto, 604-8453
Novartis Investigative Site
Kyoto, 616-8255
Novartis Investigative Site
Niigata, 951-8520
Novartis
Numakunai, 020-8505
Novartis Investigative Site
Osaka, 556-0016
Novartis Investigative Site
Osaka, 589-8511
Novartis Investigative site
Sapporo, Hokkaido
Novartis Investigative Site
Tochigi, 329-0498
Novartis Investigative Site
Tokyo, 145-0065
Novartis Investigative Site
Tokyo, 162-8666
Novartis Investigative Site
Wakayama, 641-8510

Other trials in Japan

About this study

Official title: A 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis

To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese patients with relapsing multiple sclerosis (MS)

Conditions: Multiple Sclerosis
Being tested: FTY720, Placebo
Keywords: FTY720,, MS
Medical subject headings: Multiple Sclerosis

What participants receive

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

FTY720Drug
Administered orally once daily for 6 months
PlaceboDrug
Administered orally once daily for 6 months

Study groups in NCT00537082
Study group	Role	What they receive
FTY720 0.5 mg	Experimental	FTY720 Receives: Drug: FTY720
FTY720 1.25 mg	Experimental	FTY720 Receives: Drug: FTY720
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6
Brain Magnetic Resonance Imaging (MRI) was performed at Month 3 and Month 6. Gadolinium-enhancing lesions (active lesions) represent acute inflammatory activity only and dissipate within 2-8 weeks of appearance. MRI scans were analyzed by blinded readers at the central MRI Evaluation Center to ensure consistency. Any Gd-enhanced T1 weighted MRI data obtained less than 14 days after the steroid used to treat MS relapses is invalid and excluded.
Measured: Month 3 and Month 6

Secondary outcomes (3)

Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only)
A relapse must have been confirmed by a neurologist and was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS).
Measured: up to Month 6
Number of Patients Free of New or Newly Enlarged T2 Lesions
The number of T2 lesions were obtained from MRI scans at Screening visit. The numbers of new/newly enlarging T2 lesions were obtained from MRI scans at Month 3 or more. New lesions were identified by comparing each lesion already seen in previous examinations. Lesions expanding throughout several slices were counted as only one lesion.
Measured: up to Month 3 and up to Month 6
Annualized Relapse Rate (ARR) at 6 Months
Annualized relapse rate (ARR) of the treatment group is calculated by taking the total number of confirmed relapses for all the patients in the treatment group divided by the total number of days on study for all patients in the group and multiplied by 365.25 to obtain the annual rate.
Measured: 6 Months

Timeline

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

Sep 2007Feb 2010

First posted28 Sep 2007 (estimated)
Study startSep 2007
Primary completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Multiple SclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 171 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00537082
Sponsor's protocol ID: CFTY720D1201
Status last verified: Apr 2011
First submitted: 26 Sep 2007
Last updated: 21 Apr 2011
Results posted: Yes, on ClinicalTrials.gov

Publications

Saida T, Itoyama Y, Kikuchi S, Hao Q, Kurosawa T, Ueda K, Auberson LZ, Tsumiyama I, Nagato K, Kira JI. Long-term efficacy and safety of fingolimod in Japanese patients with relapsing multiple sclerosis: 3-year results of the phase 2 extension study. BMC Neurol. 2017 Jan 28;17(1):17. doi: 10.1186/s12883-017-0794-5.
PubMed 28129749
Saida T, Kikuchi S, Itoyama Y, Hao Q, Kurosawa T, Nagato K, Tang D, Zhang-Auberson L, Kira J. A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. Mult Scler. 2012 Sep;18(9):1269-77. doi: 10.1177/1352458511435984. Epub 2012 Feb 21.
PubMed 22354739

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis
ClinicalTrials.gov ID: NCT00537082
Acronym / sponsor ID: CFTY720D1201
Conditions: Multiple Sclerosis
Keywords: FTY720,, MS
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 171 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Collaborators: Tanabe Pharma Corporation
Study start: Sep 2007
Primary completion: Feb 2010 (actual)
First posted: 28 Sep 2007 (estimated)
Results: Posted 23 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese patients with relapsing multiple sclerosis (MS)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
FTY720 0.5 mg	Experimental	Drug: FTY720FTY720
FTY720 1.25 mg	Experimental	Drug: FTY720FTY720
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Male and female patients aged 18-60
Patients with a diagnosis of multiple sclerosis

Key exclusion criteria (4 listed)

Patients with a history or presence of chronic disease of the immune system other than MS
Patients with a history or presence of malignancy, pulmonary or heart disease, etc.
Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FTY720Administered orally once daily for 6 months	Drug	FTY720 0.5 mg, FTY720 1.25 mg
PlaceboAdministered orally once daily for 6 months	Drug	Placebo

Primary outcome

Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6
Time frame: Month 3 and Month 6
Brain Magnetic Resonance Imaging (MRI) was performed at Month 3 and Month 6. Gadolinium-enhancing lesions (active lesions) represent acute inflammatory activity only and dissipate within 2-8 weeks of appearance. MRI scans were analyzed by blinded readers at the central MRI Evaluation Center to ensure consistency. Any Gd-enhanced T1 weighted MRI data obtained less than 14 days after the steroid used to treat MS relapses is invalid and excluded.

3 secondary outcomes

Number of Patients Free of MS Relapse up to Month 6 (Confirmed Relapse Only)
Time frame: up to Month 6
Number of Patients Free of New or Newly Enlarged T2 Lesions
Time frame: up to Month 3 and up to Month 6
Annualized Relapse Rate (ARR) at 6 Months
Time frame: 6 Months

Results and safety

Results posted to the registry on 23 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FTY720 1.25 mg	57	48
FTY720 0.5 mg	57	48
Placebo	57	51

Primary outcome: Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6

Time frame: Month 3 and Month 6. Number. Unit: Participants

Measure	FTY720 1.25 mg n = 50	FTY720 0.5 mg n = 50	Placebo n = 52
Value	43	35	21

Population analysed: Modified Full Analysis Set (Modified FAS) included all patients who were randomized and received at least one dose of study drug and had at least one valid post-randomized MRI scan at Month 3 or longer.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FTY720 1.25mg	11 of 54 (20.4%)	42 of 54 (77.8%)	Not reported
FTY720 0.5mg	5 of 57 (8.8%)	41 of 57 (71.9%)	Not reported
Placebo	3 of 57 (5.3%)	27 of 57 (47.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28129749Saida T, Itoyama Y, Kikuchi S, Hao Q, Kurosawa T, Ueda K, Auberson LZ, Tsumiyama I, Nagato K, Kira JI. Long-term efficacy and safety of fingolimod in Japanese patients with relapsing multiple sclerosis: 3-year results of the phase 2 extension study. BMC Neurol. 2017 Jan 28;17(1):17. doi: 10.1186/s12883-017-0794-5.
Derived from this study: PubMed 22354739Saida T, Kikuchi S, Itoyama Y, Hao Q, Kurosawa T, Nagato K, Tang D, Zhang-Auberson L, Kira J. A randomized, controlled trial of fingolimod (FTY720) in Japanese patients with multiple sclerosis. Mult Scler. 2012 Sep;18(9):1269-77. doi: 10.1177/1352458511435984. Epub 2012 Feb 21.

Related trials for Multiple Sclerosis

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RecruitingObservational study
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Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals, Japan principal investigator

+81 3 3797 8748

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FTY720 in people with Multiple Sclerosis, run by Novartis at 18 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 2 inclusion and 4 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 21 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 (time frame: Month 3 and Month 6). 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 NCT00537082, which also lists 2 linked publications.

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 21 Apr 2011.