Official title: A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis

This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.

Conditions: Relapsing Multiple Sclerosis
Being tested: FTY720
Keywords: Relapsing multiple sclerosis, MS, safety, tolerability, health outcomes

What participants receive

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

FTY720Drug

Study groups in NCT01127750
Study group	Role	What they receive
FTY720	Experimental	Not described Receives: Drug: FTY720

What is being measured

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

Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS
Measured: 4 months

Secondary outcomes (3)

Incidence of macular edema
Measured: 4 months
Incidence of bradyarrhythmic electrocardiograms (ECGs)
Measured: 4 months
Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9)
Measured: 4 months

Timeline

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

May 2010Oct 2011

First posted21 May 2010 (estimated)
Study startMay 2010
Primary completionOct 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Relapsing 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,417 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01127750
Sponsor's protocol ID: CFTY720D2316
Other IDs: 2010-019029-32
Status last verified: Feb 2017
First submitted: 19 May 2010
Last updated: 23 Feb 2017
Results posted: No

Publications

Gold R, Comi G, Palace J, Siever A, Gottschalk R, Bijarnia M, von Rosenstiel P, Tomic D, Kappos L; FIRST Study Investigators. Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population: a phase 3b, open-label study. J Neurol. 2014 Feb;261(2):267-76. doi: 10.1007/s00415-013-7115-8. Epub 2013 Nov 13.
PubMed 24221641

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 Relapsing Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis
ClinicalTrials.gov ID: NCT01127750
Acronym / sponsor ID: CFTY720D2316
Conditions: Relapsing Multiple Sclerosis
Keywords: Relapsing multiple sclerosis, MS, safety, tolerability, health outcomes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,417 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 21 May 2010 (estimated)
Results: Not posted in the source record

Clinical summary

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

This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
FTY720	Experimental	Drug: FTY720

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

18-65 years of age, must have relapsing MS

Key exclusion criteria (8 listed)

Patients with a type of MS that is not relapsing
Patients with history of chronic immune disease
Patients with a history of certain cancers
Diabetic patients with certain eye disorders
Patients who are on certain immunosuppressive medications or heart medications

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
FTY720	Drug	FTY720

Primary outcome

Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS
Time frame: 4 months

3 secondary outcomes

Incidence of macular edema
Time frame: 4 months
Incidence of bradyarrhythmic electrocardiograms (ECGs)
Time frame: 4 months
Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9)
Time frame: 4 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
Results publication: PubMed 24221641Gold R, Comi G, Palace J, Siever A, Gottschalk R, Bijarnia M, von Rosenstiel P, Tomic D, Kappos L; FIRST Study Investigators. Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population: a phase 3b, open-label study. J Neurol. 2014 Feb;261(2):267-76. doi: 10.1007/s00415-013-7115-8. Epub 2013 Nov 13.

Related trials for Relapsing Multiple Sclerosis

Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Not yet recruitingPhase 1
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
Active, not recruitingObservational study
Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)
Multiple Sclerosis
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)

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 study director

Novartis Pharmaceuticals

289 sites in 23 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FTY720 in people with Relapsing Multiple Sclerosis, run by Novartis at 289 sites in 23 countries.

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 8 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 289 sites in Germany, Italy, United Kingdom, Russia, Belgium and 18 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

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?

Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS (time frame: 4 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 NCT01127750, which also lists 1 linked publication.

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 23 Feb 2017.