Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis

A Phase 2 study testing FTY720 in people with Multiple Sclerosis, run by Novartis at 26 sites in 11 countries.

Completed

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

Trial summary

This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis. 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: 281 participants
Where: 26 sitesin 11 countries
Study dates: May 2003to Apr 2011
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

Diagnosis of relapsing multiple Sclerosis (MS)
Patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year
Patients with an Expanded Disability Status Scale (EDSS) score of 0-6
Extension Study
A positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening was negative, a second scan could have been obtained 1 month later)
Neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the Screening and Baseline periods.
Female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. Females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period.

Who cannot join

Core Study
Patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc
Pregnant or nursing women
Extension Study
Patients who had permanently discontinued study drug prior to the Month 6 visit of the core study
Patients with diabetes mellitus (to reduce the risk of ME), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study)
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

26 sites in 11 countries.

Country

City, postcode or hospital

26 sites in 11 countries

Spain5 sites

Novartis Investigational site
Barcelona
Novartis Investigational site
Madrid
Novartis Investigational site
Málaga
Novartis Investigational site
Seville
Novartis Investigational site
Valencia

Other trials in Spain

Canada4 sites

Novartis Investigational site
Montreal
Novartis Investigational site
Ottawa
Novartis Investigational site
Toronto
Novartis Investigational site
Vancouver

Other trials in Canada

Italy4 sites

Novartis Investigational site
Gallarate
Novartis Investigational site
Genova
Novartis Investigational site
Milan
Novartis Investigational site
Roma

Other trials in Italy

Finland2 sites

Novartis Investigational site
Helsinki
Novartis Investigational site
Turku

Other trials in Finland

France2 sites

Novartis Investigational site
Lille
Novartis Investigational site
Marseille

Other trials in France

Germany2 sites

Novartis Investigational site
Schwendi
Novartis Investigational site
Würzburg

Other trials in Germany

Portugal2 sites

Novartis Investigational site
Coimbra
Novartis Investigational site
Lisbon

Other trials in Portugal

Switzerland2 sites

Novartis Investigational site
Basel
Novartis Investigational site
Zurich

Other trials in Switzerland

Denmark1 site

Novartis Investigational site
Copenhagen

Other trials in Denmark

Poland1 site

Novartis Investigational site
Warsaw

Other trials in Poland

United Kingdom1 site

Novartis Investigational site
Newcastle upon Tyne

Other trials in United Kingdom

About this study

Official title: Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase

This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.

Conditions: Multiple Sclerosis
Being tested: FTY720, Placebo
Keywords: FTY720, MS, Multiple Sclerosis, RRMS
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
FTY720 capsule was taken orally once a day
PlaceboDrug
Placebo 1.25 mg capsule was given once daily

Study groups in NCT00333138
Study group	Role	What they receive
Fingolimod (FTY720) 1.25 mg/day	Experimental	Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation. Receives: Drug: FTY720
Placebo/Fingolimod (FTY720)	Placebo comparator	Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation. Receives: Drug: Placebo
Fingolimod (FTY720) 5.0 mg/day	Experimental	Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 15 to 24 months 1.25mg once daily. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation. Receives: Drug: FTY720

What is being measured

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

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.
Measured: Month 6 (Core)
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.
Measured: Month 12 (extension)
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.
Measured: Month 60 (extension)
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis. The last observation was the last observation available for each patient which ranged from 1 to 2801 days
Measured: Last observation (Up to 80 months in average)

Secondary outcomes (7)

Percentage of Participants Free of T1-weighted Lesions
A patient was defined as free of lesions if s/he had zero lesions. The last observation was the last observation available for each patient which ranged from 1 to 2801 days
Measured: Baseline, Months 6 (core), 12, 60 and Last Observation (up to 80 months in average)
Percentage of Patients Free of Gd-enhanced T1-weighted and New T2- Weighted Lesions by Visit
A patient was defined as free of lesions if s/he had zero lesions. The sum of all new T2-weighted lesions at Month 1 to last observation was zero (the sum is missing if one of the assessments was missing). New T2 lesions at a specific visit were assessed relative to the previous visit scan. Exception: new T2 lesions at Month 24 were assessed relative to Month 12. The last observation was the last observation available for each patient which ranged from 1 to 2801 days
Measured: Month 6 and 12, 60, last observation (up to 80 months in average)
Mean Number of New T2-weighted Lesions
New T2 lesions at a specific visit were assessed relative to the previous visit scan. The total number of lesions (Month 1 to end of study) is calculated as the sum of the number of lesions at Months 1 to 6, Month 12, Month 60 and last observation. The last observation was the last observation available for each patient which ranged from 1 to 2801 days
Measured: (Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)
Volume of T2-weighted Lesions
Volume of total T2-weighted lesions by visit were summarized. The last observation was the last observation available for each patient which ranged from 1 to 2801 days
Measured: (Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)
Change From Baseline in Volume of Total T2-weighted Lesions
Change in volume of total T2-weighted lesions by visit were summarized. Negative values indicate improvement (reduction in lesion volume) and positive values worsening (increase in lesion volume). The last observation was the last observation available for each patient which ranged from 1 to 2801 days.
Measured: Baseline to month 6, 12, 60 and Last observation (up to 80 months in average)
Time to Event Analysis: Kaplan Meier Estimates of Percentage of Relapse-free Patients
The Expanded Disability Status Scale (EDSS) is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \& bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method. The last observation was the last observation available for each patient which ranged from 1 to 2801 days
Measured: Month 6,12,60 and Last observation (up to 80 months in average)
Mean Trough Blood Concentrations of FTY720
For each patient, the arithmetic mean of the two FTY720 trough blood levels from month 3 and 6 was calculated. This was taken as the patient's steady-state trough levels. Venous blood samples (3 mL) were collected before the dose in ethylenediaminetetraacetic acid (EDTA)-containing tubes at protocol-scheduled visits at months 3 and 6 in all patients.
Measured: Month 3 and 6

Timeline

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

May 2003Apr 2011

First posted2 Jun 2006 (estimated)
Study startMay 2003
Primary completionApr 2011
Study completionApr 2011

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 281 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00333138
Sponsor's protocol ID: CFTY720D2201
Other IDs: CFTY720D2201E1
Status last verified: Aug 2017
First submitted: 1 Jun 2006
Last updated: 15 Sep 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.
PubMed 23531349
Kappos L, Antel J, Comi G, Montalban X, O'Connor P, Polman CH, Haas T, Korn AA, Karlsson G, Radue EW; FTY720 D2201 Study Group. Oral fingolimod (FTY720) for relapsing multiple sclerosis. N Engl J Med. 2006 Sep 14;355(11):1124-40. doi: 10.1056/NEJMoa052643.
PubMed 16971719

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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Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase
ClinicalTrials.gov ID: NCT00333138
Acronym / sponsor ID: CFTY720D2201
Conditions: Multiple Sclerosis
Keywords: FTY720, MS, Multiple Sclerosis, RRMS
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 281 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: May 2003
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 2 Jun 2006 (estimated)
Results: Posted 30 Oct 2012

Clinical summary

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

This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.

Study design

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

Arm	Type	Receives
Fingolimod (FTY720) 1.25 mg/day	Experimental	Drug: FTY720Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
Placebo/Fingolimod (FTY720)	Placebo comparator	Drug: PlaceboCore study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
Fingolimod (FTY720) 5.0 mg/day	Experimental	Drug: FTY720Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 15 to 24 months 1.25mg once daily. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.

Who may qualify

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

Key inclusion criteria (7 listed)

Diagnosis of relapsing multiple Sclerosis (MS)
Patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year
Patients with an Expanded Disability Status Scale (EDSS) score of 0-6
Extension Study
A positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening was negative, a second scan could have been obtained 1 month later)

Key exclusion criteria (7 listed)

Core Study
Patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc
Pregnant or nursing women
Extension Study
Patients who had permanently discontinued study drug prior to the Month 6 visit of the core study

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
FTY720FTY720 capsule was taken orally once a day	Drug	Fingolimod (FTY720) 1.25 mg/day, Fingolimod (FTY720) 5.0 mg/day
PlaceboPlacebo 1.25 mg capsule was given once daily	Drug	Placebo/Fingolimod (FTY720)

Primary outcome

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)
Time frame: Month 6 (Core)
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12
Time frame: Month 12 (extension)
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60
Time frame: Month 60 (extension)
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study
Time frame: Last observation (Up to 80 months in average)
Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis. The last observation was the last observation available for each patient which ranged from 1 to 2801 days

7 secondary outcomes

Percentage of Participants Free of T1-weighted Lesions
Time frame: Baseline, Months 6 (core), 12, 60 and Last Observation (up to 80 months in average)
Percentage of Patients Free of Gd-enhanced T1-weighted and New T2- Weighted Lesions by Visit
Time frame: Month 6 and 12, 60, last observation (up to 80 months in average)
Mean Number of New T2-weighted Lesions
Time frame: (Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)
Volume of T2-weighted Lesions
Time frame: (Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)
Change From Baseline in Volume of Total T2-weighted Lesions
Time frame: Baseline to month 6, 12, 60 and Last observation (up to 80 months in average)
Time to Event Analysis: Kaplan Meier Estimates of Percentage of Relapse-free Patients
Time frame: Month 6,12,60 and Last observation (up to 80 months in average)
Mean Trough Blood Concentrations of FTY720
Time frame: Month 3 and 6

Results and safety

Results posted to the registry on 30 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	93	86
Fingolimod (FTY720) 1.25 mg/Day	94	88
Fingolimod (FTY720) 5.0 mg/Day	94	82

Primary outcome: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)

Time frame: Month 6 (Core). Mean (Standard Deviation). Unit: GD- enhanced T1 lesions

Measure	Placebo n = 83	Fingolimod (FTY720) 1.25 mg/Day n = 90	Fingolimod (FTY720) 5.0 mg/Day n = 87
Value	2.3 (4.23)	1.4 (5.69)	0.4 (0.82)

Population analysed: All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.

Primary outcome: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12

Time frame: Month 12 (extension). Mean (Standard Deviation). Unit: GD- enhanced T1 lesions

Measure	Placebo n = 72	Fingolimod (FTY720) 1.25 mg/Day n = 77	Fingolimod (FTY720) 5.0 mg/Day n = 71
Value	0.4 (0.95)	1.0 (5.81)	0.2 (0.47)

Primary outcome: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60

Time frame: Month 60 (extension). Mean (Standard Deviation). Unit: GD- enhanced T1 lesions

Measure	Placebo n = 45	Fingolimod (FTY720) 1.25 mg/Day n = 49	Fingolimod (FTY720) 5.0 mg/Day n = 44
Value	0.2 (0.7)	0.2 (0.92)	0.1 (0.55)

Primary outcome: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study

Time frame: Last observation (Up to 80 months in average). Mean (Standard Deviation). Unit: GD- enhanced T1 lesions

Measure	Placebo n = 92	Fingolimod (FTY720) 1.25 mg/Day n = 93	Fingolimod (FTY720) 5.0 mg/Day n = 92
Value	0.8 (2.87)	0.4 (1.39)	0.5 (1.65)

7 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
Placebo	25 of 93 (26.9%)	86 of 93 (92.5%)	Not reported
Fingolimod (FTY720) 1.25 mg	19 of 94 (20.2%)	88 of 94 (93.6%)	Not reported
Fingolimod (FTY720) 5.0 mg	32 of 94 (34%)	92 of 94 (97.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23531349Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.
Derived from this study: PubMed 16971719Kappos L, Antel J, Comi G, Montalban X, O'Connor P, Polman CH, Haas T, Korn AA, Karlsson G, Radue EW; FTY720 D2201 Study Group. Oral fingolimod (FTY720) for relapsing multiple sclerosis. N Engl J Med. 2006 Sep 14;355(11):1124-40. doi: 10.1056/NEJMoa052643.

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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 study chair

Novartis Pharmaceuticals

26 sites in 11 countries: 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 26 sites in 11 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 7 inclusion and 7 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 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Spain, Canada, Italy, Finland, France and 6 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. 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 30 Oct 2012). 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?

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (time frame: Month 6 (Core)). The study lists 4 primary outcomes in all. 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 NCT00333138, 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 15 Sep 2017.