CognitionPhase 4NCT02575365

Effect of Fingolimod on Neurodegeneration

A Phase 4 study testing 0,5 mg Fingolimod in people with Cognition and Brain Volume Loss, run by Novartis Pharmaceuticals at 3 sites in Turkey (Türkiye).

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This was a 24-month, open-label, multicenter study with a single treatment arm design. Primary objective of this study was: -To investigate the effects of Fingolimod on cognitive performance in highly active relapsing remitting multiple sclerosis patients Secondary objectives of this study were: To investigate the… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Cognition, Brain Volume Loss
What is being tested?: 0,5 mg Fingolimod
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 3 sitesTurkey (Türkiye)
Study dates: 16 Feb 2016to 27 Jan 2017
Phase: Phase 4
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Diagnosed with RRMS as described in 2010 McDonald criteria (36)
Provided written informed consent prior to any intervention
Unresponsive to treatment with a beta interferon or glatiramer acetate for a minimum of one year at and at adequate dose and with high disease activity .
(Unresponsive patients: patients with no changes in relapses, increased relapses, severer relapses with one-year treatment or those who had had at least one relapse during the past one year under previous treatments and one or multiple contrast enhancing lesions in cranial MRI or increased T2 lesions in successive MRIs)
EDSS score below 5.5 at screening

Who cannot join

1. Patients with primary or secondary progressive or progressive relapsing MS. 2. Patients with known contraindications for fingolimod treatment. 3. Other coexistent autoimmune diseases including Hashimoto thyroiditis, systemic lupus erythematosus, rheumatoid anthiritis, psoriasis etc.
4. Patients with any of the following cardiovascular conditions:
Resting heart rate < 45 bpm/min
Cardiac failure at any time during the first study visit (Class III as per NYHA classification) or significant heart disease as judged by the physician
Myocardial infarction during the last 6 months
History of Mobitz Type II grade 2 AV block

Show all 17Show fewer

Past or current grade 3 AV block
Confirmed history of sick sinus syndrome or sino-atrial heart block
arrhythmia requiring current treatment with Class Ia drugs (ajmaline, disopyramid, procainamide, quinidine)
hypertension uncontrolled with medication 5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, detected by urinalysis and confirmed by a positive hCG laboratory test.
7. Negative for varicella-zoster virus IgG antibodies at screening. Patients who have negative results for varicella-zoster virus IgG antibodies can be included in the study after vaccination for varicella-zoster virus.
8. Active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively 9. History of previous fingolimod therapy 10. Patient who received any of the treatments below:
Corticosteroids or adrenocorticotropic hormone (ACTH) during the last 1 month
Immunosuppressive medications such as azathioprine or methotrexate etc.
Immunoglobulin treatment during the last 3 months
Cladribine, cyclophosphamide, mitoxantrone, natalizumab at any time

Trial locations and contacts

3 sites in 1 country.

Turkey (Türkiye)3 sites

Novartis Investigative Site
Bursa, 16059
Novartis Investigative Site
Kocaeli, 41380
Novartis Investigative Site
Kütahya, 43000

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Fingolimod on Neurodegeneration, Brain Atrophy and Cognitive Impairment in Relapsing Remitting Multiple Sclerosis Patients

This was a 24-month, open-label, multicenter study with a single treatment arm design.

Primary objective of this study was:

-To investigate the effects of Fingolimod on cognitive performance in highly active relapsing remitting multiple sclerosis patients

Secondary objectives of this study were:

To investigate the correlation between the effect of fingolimod on cognitive performances and MRI data.
To evaluate the effect of fingolimod on biomarkers (24 hydroxy cholesterol, osteopontin and matrix metalloproteinases) related to neurodegeneration
To investigate the effect of fingolimod on brain gray matter atrophy and thalamic atrophy.

Polulation The hope was to recruit a minimum of 80 relapsing remitting MS (RRMS) patients according to the McDonald criteria.

Conditions: Cognition, Brain Volume Loss
Being tested: 0,5 mg Fingolimod
Keywords: RRMS,, Cognition,, brain,, Fingolimod,, Multiple Sclerosis,, neurodegeneration,, Brain atrophy,, gray matter atrophy,, thalamic atrophy,, biomarkers,, BICAMS Battery,
Medical subject headings: Multiple Sclerosis, Nerve Degeneration

What participants receive

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

0,5 mg FingolimodDrug
0.5 mg p.o fingolimod daily

Study groups in NCT02575365
Study group	Role	What they receive
Fingolimod arm	Experimental	0.5 mg p.o fingolimod daily Receives: Drug: 0,5 mg Fingolimod

What is being measured

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

Change From Baseline in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery Test at 12 Months
The Brief International Cognitive Assessment for MS ( BICAMS Battery ) includes 3 cognitive tests, 1-Symbol Digit Modalities Test (SDMT, 2-the second edition of the California Verbal Learning Test (CVLT2) and 3-the revised Brief Visuospatial Memory Test (BVMTR).
Measured: baseline , month 12.
Change From Baseline in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery Test at 24 Months
The Brief International Cognitive Assessment for MS (BICAMS Battery) includes 3 cognitive tests, 1-Symbol Digit Modalities Test (SDMT, 2-the second edition of the California Verbal Learning Test (CVLT2) and 3-the revised Brief Visuospatial Memory Test (BVMTR).
Measured: baseline and month 24

Secondary outcomes (5)

Change From Baseline in PASAT Test
The Paced Auditory Serial Addition Test (PASAT) has been widely used in MS trials and it is considered to be a measure of sustained attention, divided attention, concentration, and information processing speed.
Measured: baseline ,months 6, month 12 and month 24
Change From Baseline in Stroop Test
The Stroop Color and Word Test assesses cognitive processing and provides valuable diagnostic information on brain dysfunction, cognition, and psychopathology
Measured: baseline, month 6, month 12 and month 24
Change From Baseline in Brain Gray Matter Atrophy and Thalamic Atrophy
MRI scans will be obtained by using 1,5T MRI for measuring gray matter atrophy and thalamic atrophy and a standard scanning protocol will be used for MRI in all centers.
Measured: baseline, month 6, month 12, month 18 and month 24
Change From Baseline in Serum Levels of 24S-hydroxycholesterol (24OHC) , Osteopontin and Matrix Metalloproteinases (and Also MMPI's)
Serum samples will be collected at baseline and at months 6, 12 and 24 from each participant after evaluation for inclusion and exclusion criteria for measurement of 24 hydroxy cholesterol, osteopontin and matrix metalloproteinases (including MMPI's).
Measured: baseline, month 6, month , month 12 and month 24
the Correlation Between Effect of Fingolimod on Cognitive Performances and Brain Atrophy (Gray Matter Atrophy and Thalamic Atrophy) by Comparing Baseline and Month 24.
Correlation between effect of fingolimod on cognitive performances based on cognitive tests and brain atrophy based on MRI assessments will be explored.
Measured: baseline, month 24

Timeline

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

16 Feb 201627 Jan 2017

First posted14 Oct 2015 (estimated)
Study start16 Feb 2016
Primary completion27 Jan 2017
Study completion27 Jan 2017

Why it stopped: The trial was terminated due to low enrollment.

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.
Other trials for CognitionStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02575365
Sponsor's protocol ID: CFTY720DTR05
Status last verified: Oct 2018
First submitted: 12 Oct 2015
Last updated: 27 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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 Cognition trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Fingolimod on Neurodegeneration, Brain Atrophy and Cognitive Impairment in Relapsing Remitting Multiple Sclerosis Patients
ClinicalTrials.gov ID: NCT02575365
Acronym / sponsor ID: CFTY720DTR05
Conditions: Cognition, Brain Volume Loss
Keywords: RRMS,, Cognition,, brain,, Fingolimod,, Multiple Sclerosis,, neurodegeneration,, Brain atrophy,, gray matter atrophy,
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The trial was terminated due to low enrollment.
Enrolment: 4 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 16 Feb 2016 (actual)
Primary completion: 27 Jan 2017 (actual)
Study completion: 27 Jan 2017 (actual)
First posted: 14 Oct 2015 (estimated)
Results: Posted 27 Feb 2019

Clinical summary

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

This was a 24-month, open-label, multicenter study with a single treatment arm design.

Primary objective of this study was:

-To investigate the effects of Fingolimod on cognitive performance in highly active relapsing remitting multiple sclerosis patients

Secondary objectives of this study were:

To investigate the correlation between the effect of fingolimod on cognitive performances and MRI data.
To evaluate the effect of fingolimod on biomarkers (24 hydroxy cholesterol, osteopontin and matrix metalloproteinases) related to neurodegeneration
To investigate the effect of fingolimod on brain gray matter atrophy and thalamic atrophy.

Polulation The hope was to recruit a minimum of 80 relapsing remitting MS (RRMS) patients according to the McDonald criteria.

Study design

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

Arm	Type	Receives
Fingolimod arm	Experimental	Drug: 0,5 mg Fingolimod0.5 mg p.o fingolimod daily

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosed with RRMS as described in 2010 McDonald criteria (36)
Provided written informed consent prior to any intervention
Unresponsive to treatment with a beta interferon or glatiramer acetate for a minimum of one year at and at adequate dose and with high disease activity .
(Unresponsive patients: patients with no changes in relapses, increased relapses, severer relapses with one-year treatment or those who had had at least one relapse during the past one year under previous treatments and one or multiple contrast enhancing lesions in cranial MRI or increased T2 lesions in successive MRIs)
EDSS score below 5.5 at screening

Key exclusion criteria (17 listed)

1. Patients with primary or secondary progressive or progressive relapsing MS. 2. Patients with known contraindications for fingolimod treatment. 3. Other coexistent autoimmune diseases including Hashimoto thyroiditis, systemic lupus erythematosus, rheumatoid anthiritis, psoriasis etc.
6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, detected by urinalysis and confirmed by a positive hCG laboratory test.
7. Negative for varicella-zoster virus IgG antibodies at screening. Patients who have negative results for varicella-zoster virus IgG antibodies can be included in the study after vaccination for varicella-zoster virus.
8. Active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively 9. History of previous fingolimod therapy 10. Patient who received any of the treatments below:

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
0,5 mg Fingolimod0.5 mg p.o fingolimod daily	Drug	Fingolimod arm

Primary outcome

Change From Baseline in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery Test at 12 Months
Time frame: baseline , month 12.
The Brief International Cognitive Assessment for MS ( BICAMS Battery ) includes 3 cognitive tests, 1-Symbol Digit Modalities Test (SDMT, 2-the second edition of the California Verbal Learning Test (CVLT2) and 3-the revised Brief Visuospatial Memory Test (BVMTR).
Change From Baseline in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery Test at 24 Months
Time frame: baseline and month 24
The Brief International Cognitive Assessment for MS (BICAMS Battery) includes 3 cognitive tests, 1-Symbol Digit Modalities Test (SDMT, 2-the second edition of the California Verbal Learning Test (CVLT2) and 3-the revised Brief Visuospatial Memory Test (BVMTR).

5 secondary outcomes

Change From Baseline in PASAT Test
Time frame: baseline ,months 6, month 12 and month 24
Change From Baseline in Stroop Test
Time frame: baseline, month 6, month 12 and month 24
Change From Baseline in Brain Gray Matter Atrophy and Thalamic Atrophy
Time frame: baseline, month 6, month 12, month 18 and month 24
Change From Baseline in Serum Levels of 24S-hydroxycholesterol (24OHC) , Osteopontin and Matrix Metalloproteinases (and Also MMPI's)
Time frame: baseline, month 6, month , month 12 and month 24
the Correlation Between Effect of Fingolimod on Cognitive Performances and Brain Atrophy (Gray Matter Atrophy and Thalamic Atrophy) by Comparing Baseline and Month 24.
Time frame: baseline, month 24

Results and safety

Results posted to the registry on 27 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fingolimod Arm	4	0

Primary outcome: Change From Baseline in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery Test at 12 Months

Time frame: baseline , month 12.

Population analysed: The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.

Primary outcome: Change From Baseline in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery Test at 24 Months

Time frame: baseline and month 24

Population analysed: The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, up to approximately 11 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fingolimod Arm	0 of 4 (0%)	1 of 4 (25%)	0 of 4

Limitations and caveats (from the sponsor): The trial was terminated due to low enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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 director

Novartis Pharmaceuticals

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 0,5 mg Fingolimod in people with Cognition and Brain Volume Loss, run by Novartis Pharmaceuticals at 3 sites in Turkey (Türkiye).

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 5 inclusion and 17 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: stopped early, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 27 Feb 2019). 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?

Change From Baseline in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery Test at 12 Months (time frame: baseline , month 12.). The study lists 2 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 NCT02575365.

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 27 Feb 2019.