Trial Outcomes & Findings for Effect of Fingolimod on Neurodegeneration (NCT NCT02575365)
NCT ID: NCT02575365
Last Updated: 2019-02-27
Results Overview
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).
TERMINATED
PHASE4
4 participants
baseline , month 12.
2019-02-27
Participant Flow
It was planned to recruit 80 patients. By the end of the first year, 4 patients have been recruited and the study was stopped due to low enrollment and study results were analyzed.
Participant milestones
| Measure |
Fingolimod Arm
0.5 mg p.o fingolimod daily
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Fingolimod Arm
0.5 mg p.o fingolimod daily
|
|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
Effect of Fingolimod on Neurodegeneration
Baseline characteristics by cohort
| Measure |
Fingolimod Arm
n=4 Participants
0.5 mg p.o fingolimod daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline , month 12.Population: The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.
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).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: baseline and month 24Population: The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline ,months 6, month 12 and month 24Population: The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, month 6, month 12 and month 24Population: The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.
The Stroop Color and Word Test assesses cognitive processing and provides valuable diagnostic information on brain dysfunction, cognition, and psychopathology
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, month 6, month 12, month 18 and month 24Population: The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, month 6, month , month 12 and month 24Population: The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, month 24Population: The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.
Correlation between effect of fingolimod on cognitive performances based on cognitive tests and brain atrophy based on MRI assessments will be explored.
Outcome measures
Outcome data not reported
Adverse Events
Fingolimod Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fingolimod Arm
n=4 participants at risk
0.5 mg p.o fingolimod daily
|
|---|---|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • 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.
|
|
Nervous system disorders
Balance disorder
|
25.0%
1/4 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER