Trial · NCT02575365
Effect of Fingolimod on Neurodegeneration
NCT02575365, Phase 4, Terminated, Novartis Pharmaceuticals; results first posted 2019-02-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Fingolimod on Neurodegeneration. Trials, record NCT02575365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02575365
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Fingolimod on Neurodegeneration
- NCT number
- NCT02575365
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 4 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Cognition, Brain Volume Loss
- Interventions
- 0,5 mg Fingolimod
- First posted
- 2015-10-14
- Last updated
- 2019-02-27
- Results first posted
- 2019-02-27
- Limitations and caveats
- The trial was terminated due to low enrollment.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery Test at 12 Months | 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). |
| Primary | Change From Baseline in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery Test at 24 Months | 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). |
| Secondary | Change From Baseline in PASAT Test | baseline ,months 6, month 12 and month 24 | 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. |
| Secondary | Change From Baseline in Stroop Test | baseline, month 6, month 12 and month 24 | The Stroop Color and Word Test assesses cognitive processing and provides valuable diagnostic information on brain dysfunction, cognition, and psychopathology |
| Secondary | Change From Baseline in Brain Gray Matter Atrophy and Thalamic Atrophy | baseline, month 6, month 12, month 18 and month 24 | 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. |
| Secondary | Change From Baseline in Serum Levels of 24S-hydroxycholesterol (24OHC) , Osteopontin and Matrix Metalloproteinases (and Also MMPI's) | baseline, month 6, month , month 12 and month 24 | 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). |
| Secondary | the Correlation Between Effect of Fingolimod on Cognitive Performances and Brain Atrophy (Gray Matter Atrophy and Thalamic Atrophy) by Comparing Baseline and Month 24. | baseline, month 24 | Correlation between effect of fingolimod on cognitive performances based on cognitive tests and brain atrophy based on MRI assessments will be explored. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery Test at 12 Months | baseline , month 12. | The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted. | ||
| PRIMARY | Change From Baseline in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery Test at 24 Months | baseline and month 24 | The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted. | ||
| SECONDARY | Change From Baseline in PASAT Test | baseline ,months 6, month 12 and month 24 | The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted. | ||
| SECONDARY | Change From Baseline in Stroop Test | baseline, month 6, month 12 and month 24 | The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted. | ||
| SECONDARY | Change From Baseline in Brain Gray Matter Atrophy and Thalamic Atrophy | baseline, month 6, month 12, month 18 and month 24 | The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted. | ||
| SECONDARY | Change From Baseline in Serum Levels of 24S-hydroxycholesterol (24OHC) , Osteopontin and Matrix Metalloproteinases (and Also MMPI's) | baseline, month 6, month , month 12 and month 24 | The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted. | ||
| SECONDARY | the Correlation Between Effect of Fingolimod on Cognitive Performances and Brain Atrophy (Gray Matter Atrophy and Thalamic Atrophy) by Comparing Baseline and Month 24. | baseline, month 24 | The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fingolimod Arm | 4 | |
| Overall Study | COMPLETED | Fingolimod Arm | 0 | |
| Overall Study | NOT COMPLETED | Fingolimod Arm | 4 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Fingolimod Arm | 1 | 4 | 1 |
| other | Balance disorder | Nervous system disorders | Fingolimod Arm | 1 | 4 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fingolimod Arm | 0 | 4 |
| Total, other adverse events | Fingolimod Arm | 1 | 4 |
| Total, serious adverse events | Fingolimod Arm | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Symbol Coding | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
| Paced Visual Serial Addition Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02575365
GET https://conductscience.org/api/trials/v1/NCT02575365/registered