Trial Outcomes & Findings for Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage (NCT NCT04088630)
NCT ID: NCT04088630
Last Updated: 2025-01-23
Results Overview
Number of participants with clinically significant cardiac events. Clinically significant cardiac events include myocardial infarction, unstable angina, stroke, transient ischemic attack, any heart failure, bradycardia and heart block. Cardiac events were monitored with telemetry up to and after 72 hours while hospitalized. A check in was performed at 30 days with an in-person clinical or hospital visit to ascertain any cardiac events via patient discussion and medical record review.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
28 participants
Primary outcome timeframe
up to 30 days post-ictus
Results posted on
2025-01-23
Participant Flow
Adult patients coming the Emergency Department or direct admitted to the Neurosciences Intensive Care Unit at Wake Forest Baptist Hospital between August 2020 and June 2023 with the diagnosis of spontaneous ICH will be identified as potentially eligible participants and screened by interview.
Consented participants who can be administered an oral drug will be allocated to Fingolimod or Placebo study groups using a computer-based random number-generating allocation. Consented participants who are unable to be administered the oral drug or placebo are assigned to the open-label group.
Participant milestones
| Measure |
Fingolimod
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
Open-label Fingolimod
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
11
|
|
Overall Study
24h Post-ictus
|
8
|
7
|
11
|
|
Overall Study
72h Post-ictus
|
9
|
7
|
10
|
|
Overall Study
5-7 Days
|
9
|
6
|
7
|
|
Overall Study
10-14 Days
|
4
|
2
|
7
|
|
Overall Study
30 Days
|
9
|
5
|
7
|
|
Overall Study
90 Days
|
9
|
5
|
8
|
|
Overall Study
180 Days
|
6
|
5
|
5
|
|
Overall Study
365 Days
|
3
|
4
|
6
|
|
Overall Study
COMPLETED
|
3
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
8
|
Reasons for withdrawal
| Measure |
Fingolimod
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
Open-label Fingolimod
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
6
|
|
Overall Study
Death
|
3
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
Baseline Characteristics
Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage
Baseline characteristics by cohort
| Measure |
Fingolimod
n=9 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=8 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
Open-label Fingolimod
n=11 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.0 years
n=5 Participants
|
67.0 years
n=7 Participants
|
59.0 years
n=5 Participants
|
66.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Prior stroke
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Hypertension
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Diabetes
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Coronary Artery Disease
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Hyperlipidemia
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Obesity
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Atrial Fibrillation
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Smoking Status
Current or Former
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Smoking Status
Never
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Smoking Status
Unknown
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Antiplatelet medication
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Anticoagulant Medication
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to 30 days post-ictusPopulation: All enrolled participants
Number of participants with clinically significant cardiac events. Clinically significant cardiac events include myocardial infarction, unstable angina, stroke, transient ischemic attack, any heart failure, bradycardia and heart block. Cardiac events were monitored with telemetry up to and after 72 hours while hospitalized. A check in was performed at 30 days with an in-person clinical or hospital visit to ascertain any cardiac events via patient discussion and medical record review.
Outcome measures
| Measure |
Open-label Fingolimod
n=11 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=9 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=8 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Cardiac Events
|
0 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 90 days post-ictusPopulation: All enrolled participants by group
Rate of nosocomial infections (UTI, sepsis, and pneumonia) by group
Outcome measures
| Measure |
Open-label Fingolimod
n=11 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=9 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=8 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Rate of Nosocomial Infections (UTI, Sepsis, and Pneumonia)
|
5 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: up to 30 days post-ictusPopulation: All three arms where data were available at 90 days
considered a change ≥ 4 points of the NIHSS between enrollment and 30 days post-ictus. A higher score indicates higher severity and poorer prognosis. Scale is 0-42.
Outcome measures
| Measure |
Open-label Fingolimod
n=7 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=7 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=5 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Rate of Neurologic Decline
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: EnrollmentPopulation: 11 subjects enrolled in open-label arm
Rate of successful administration of fingolimod through an NGT or Dobhoff tube in Open-label group only
Outcome measures
| Measure |
Open-label Fingolimod
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=11 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Rate of Successful Administration of Fingolimod Through an NGT or Dobhoff Tube
|
—
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: Enrollment to 30 daysPopulation: Subjects where 30 day labs were obtained are included in this analysis
Percent Change in Lymphocyte Subpopulations of CD4+ T Cells
Outcome measures
| Measure |
Open-label Fingolimod
n=6 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=6 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=4 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Percent Change in Lymphocyte Subpopulations of CD4+ T Cells
|
-5.00 percent change
Interval -14.7 to 40.5
|
19.6 percent change
Interval -18.8 to 81.9
|
-2.56 percent change
Interval -10.3 to 3.52
|
SECONDARY outcome
Timeframe: Enrollment and 30 daysPopulation: Subjects where 30 day labs were obtained are included in this analysis
Percent change in lymphocyte subpopulations of CD8+ T Cells
Outcome measures
| Measure |
Open-label Fingolimod
n=6 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=6 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=4 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Percent Change in Lymphocyte Subpopulations of CD8+ T Cells
|
21.6 percent change
Interval -61.5 to 82.9
|
19.3 percent change
Interval -20.4 to 59.0
|
21.4 percent change
Interval -6.09 to 113.0
|
SECONDARY outcome
Timeframe: Enrollment and 30 daysPopulation: Subjects where 30 day labs were obtained are included in this analysis
Percent change in lymphocyte subpopulations of CD19+ B cells
Outcome measures
| Measure |
Open-label Fingolimod
n=6 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=6 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=4 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Percent Change in Lymphocyte Subpopulations of CD19+ B Cells
|
9.22 percent change
Interval -84.1 to 43.8
|
121 percent change
Interval -39.4 to 186.0
|
0.230 percent change
Interval -16.9 to 16.5
|
SECONDARY outcome
Timeframe: Enrollment and 365 daysPopulation: All enrolled subjects included in analysis. Fingolimod group included 18 observations, placebo included 14 observations and open-label included 23 observations across the time period.
Average decrease per day by group in volumetric measurement calculations of hematoma obtained by MRI between enrollment and 365 days. All MRI imaging data obtained on hematoma volume between enrollment and 365 days were used to calculate estimates via a linear mixed effects model controlling for repeated measures within subject.
Outcome measures
| Measure |
Open-label Fingolimod
n=11 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=9 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=8 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Change in Hematoma Volume Obtained by MRI
|
-210.03 mm^3 per day
Standard Error 23.81
|
-247.19 mm^3 per day
Standard Error 75.68
|
-86.29 mm^3 per day
Standard Error 17.74
|
SECONDARY outcome
Timeframe: Enrollment and 365 daysPopulation: All enrolled subjects included in analysis. Fingolimod group included 46 observations, placebo included 39 observations and open-label included 60 observations across the time period.
Average decrease per day by group in volumetric measurement calculations of hematoma obtained by CT between enrollment and 365 days. All CT imaging data obtained on hematoma volume between enrollment and 365 days were used to calculate estimates via a linear mixed effects model controlling for repeated measures within subject.
Outcome measures
| Measure |
Open-label Fingolimod
n=11 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=9 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=8 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Change in Hematoma Volume Obtained by CT
|
-86.73 mm^3 per day
Standard Error 15.95
|
-156.84 mm^3 per day
Standard Error 46.35
|
-90.56 mm^3 per day
Standard Error 54.89
|
SECONDARY outcome
Timeframe: Enrollment to 365 daysPopulation: All enrolled subjects included in analysis. Fingolimod group included 46 observations, placebo included 39 observations and open-label included 60 observations across the time period.
Average decrease per day by group in volumetric measurement calculations of peri-hematomal edema volume between enrollment and 365 days. All CT imaging data obtained on peri-hematomal edema volume between enrollment and 365 days were used to calculate estimates via a linear mixed effects model controlling for repeated measures within subject.
Outcome measures
| Measure |
Open-label Fingolimod
n=11 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=9 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=8 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Change in Peri-hematomal Edema Volume Obtained by CT
|
-64.93 mm^3
Standard Error 16.33
|
-65.85 mm^3
Standard Error 47.50
|
-62.21 mm^3
Standard Error 64.76
|
SECONDARY outcome
Timeframe: Enrollment to 365 daysPopulation: All enrolled subjects included in analysis. Fingolimod group included 18 observations, placebo included 14 observations and open-label included 23 observations across the time period.
Average decrease per day by group in volumetric measurement calculations of peri-hematomal edema obtained from radiographic imaging (MRI) between enrollment and 365 days. All MRI imaging data obtained on peri-hematomal edema volume between enrollment and 365 days were used to calculate estimates via a linear mixed effects model controlling for repeated measures within subject.
Outcome measures
| Measure |
Open-label Fingolimod
n=11 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=9 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=8 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Change in Peri-hematomal Edema Volume Obtained by MRI
|
-74.96 mm^3
Standard Error 55.84
|
-327.12 mm^3
Standard Error 89.61
|
-118.36 mm^3
Standard Error 31.75
|
SECONDARY outcome
Timeframe: 365 daysPopulation: Subjects where score was collected at 365 days.
The scoring range is 0 to 42 points, with higher numbers indicating greater severity. (NIHSS)
Outcome measures
| Measure |
Open-label Fingolimod
n=4 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=2 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=4 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
National Institutes of Health Stroke Scale Total Score (NIHSS)
|
5 score on a scale
Interval 0.0 to 8.0
|
0 score on a scale
Interval 0.0 to 0.0
|
1 score on a scale
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 365 days post-ictusPopulation: Subjects where scores were collected at 365 days.
The modified Rankin Scale (mRS) will measure functional recovery and ability to perform activities of daily living. The mRS is a 6 point disability scale with scores ranging from 0 (no symptoms) to 5 (severe disability) with 6 indicating death. Lower scores denote better outcome.
Outcome measures
| Measure |
Open-label Fingolimod
n=6 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=2 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=4 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Interviewer-administered Modified Rankin Scale (mRS)
|
2.5 score on a scale
Interval 1.0 to 3.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 365 daysPopulation: Subjects completing instrument at 365 days.
Patient-Reported Outcomes Measurement Information System (PROMIS) 10 questionnaire will measure patient self-reporting of physical and neurobehavioral functions. Mean T-score for general population is 50 with standard deviation of 10. Higher T-scores indicate better physical and mental health. Typically, T-score ranges from 20 to 80.
Outcome measures
| Measure |
Open-label Fingolimod
n=3 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=2 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=4 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information (PROMIS) 10 Questionnaire
Physical T Score
|
47.7 score on a scale
Interval 39.8 to 50.8
|
48.2 score on a scale
Interval 42.3 to 54.1
|
55.9 score on a scale
Interval 44.9 to 61.9
|
|
Patient-Reported Outcomes Measurement Information (PROMIS) 10 Questionnaire
Mental T Score
|
41.1 score on a scale
Interval 41.1 to 50.8
|
53.4 score on a scale
Interval 47.7 to 59.0
|
47.7 score on a scale
Interval 33.8 to 62.5
|
SECONDARY outcome
Timeframe: 365 daysPopulation: Subjects completing instrument at 365 days.
Montreal Cognitive Assessment (MoCA) will measure recovery (neurocognitive). Scores range from 0 to 30 with higher scores denoting better outcomes.
Outcome measures
| Measure |
Open-label Fingolimod
n=3 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=2 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=4 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
|
20 score on a scale
Interval 17.0 to 25.0
|
25 score on a scale
Interval 24.0 to 26.0
|
24 score on a scale
Interval 21.0 to 25.0
|
SECONDARY outcome
Timeframe: 365 daysPopulation: Subjects completing instrument at 365 days.
Western Aphasia Battery-Revised (WAB-R) will measure recovery (neurocognitive and speech). Language and Aphasia subscale scores both range from 0 to 100. Higher scores denote better outcome.
Outcome measures
| Measure |
Open-label Fingolimod
n=3 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=2 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=4 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Western Aphasia Battery-Revised (WAB-R)
Language score
|
90.0 score on a scale
Interval 70.6 to 93.1
|
98.8 score on a scale
Interval 97.5 to 100.0
|
96.9 score on a scale
Interval 86.9 to 98.8
|
|
Western Aphasia Battery-Revised (WAB-R)
Aphasia score
|
95.0 score on a scale
Interval 73.3 to 95.8
|
100 score on a scale
Interval 100.0 to 100.0
|
98.3 score on a scale
Interval 94.2 to 100.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: All enrolled subjects
Mortality at 30 days
Outcome measures
| Measure |
Open-label Fingolimod
n=11 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=9 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=8 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Mortality
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 90 daysMortality at 90 days
Outcome measures
| Measure |
Open-label Fingolimod
n=11 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=9 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=8 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
Mortality
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 365 daysPopulation: All enrolled subjects
All cause mortality within 365 days
Outcome measures
| Measure |
Open-label Fingolimod
n=11 Participants
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
Fingolimod
n=9 Participants
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=8 Participants
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
|---|---|---|---|
|
All Cause Mortality
|
1 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
Fingolimod
Serious events: 3 serious events
Other events: 0 other events
Deaths: 3 deaths
Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Open-label Fingolimod
Serious events: 5 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Fingolimod
n=9 participants at risk
In addition to Standard of care treatment, those participants randomized to the fingolimod group will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset.
Fingolimod: A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
|
Control
n=8 participants at risk
In addition to Standard of care treatment, those participants randomized to the control group will receive a single dose placebo pill within 24 hours of symptom onset
Control: A single oral placebo pill within 24 hours of symptom onset
|
Open-label Fingolimod
n=11 participants at risk
In addition to standard of care treatment,10 subjects will be assigned to the open-label group who will receive a single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset to assess feasibility of administration through NGT or Dobhoff tube.
Open-label Fingolimod: A single dose of 0.5 mg fingolimod through an NGT or Dobhoff tube within 24 hours of symptom onset
|
|---|---|---|---|
|
Cardiac disorders
Cardiac event
|
33.3%
3/9 • Number of events 3 • Enrollment to 365 days
|
0.00%
0/8 • Enrollment to 365 days
|
0.00%
0/11 • Enrollment to 365 days
|
|
Infections and infestations
Infection
|
11.1%
1/9 • Number of events 1 • Enrollment to 365 days
|
12.5%
1/8 • Number of events 1 • Enrollment to 365 days
|
45.5%
5/11 • Number of events 5 • Enrollment to 365 days
|
Other adverse events
Adverse event data not reported
Additional Information
Carol Kittel, Senior Biostatistician
Wake Forest University School of Medicine
Phone: 336-399-3832
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place