Trial Outcomes & Findings for A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS) (NCT NCT03387046)
NCT ID: NCT03387046
Last Updated: 2020-02-10
Results Overview
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with Multiple Sclerosis (MS). It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2020-02-10
Participant Flow
Participant milestones
| Measure |
D-aspartate + IFN Beta-1a + Methylprednisolone
Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
Placebo + IFN Beta-1a + Methylprednisolone
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
2
|
|
Overall Study
COMPLETED
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
D-aspartate + IFN Beta-1a + Methylprednisolone
Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
Placebo + IFN Beta-1a + Methylprednisolone
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
Baseline Characteristics
A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS)
Baseline characteristics by cohort
| Measure |
D-aspartate + IFN Beta-1a + Methylprednisolone
n=5 Participants
Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
Placebo + IFN Beta-1a + Methylprednisolone
n=2 Participants
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: Full analysis set included all participants enrolled into the study and assigned to the randomized treatment.
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with Multiple Sclerosis (MS). It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS).
Outcome measures
| Measure |
D-aspartate + IFN Beta-1a + Methylprednisolone
n=5 Participants
Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
Placebo + IFN Beta-1a + Methylprednisolone
n=2 Participants
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
|---|---|---|
|
Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 8
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and 24Population: Full analysis set included all participants enrolled into the study and assigned to the randomized treatment.
EDSS is an ordinal scale in half-point increments that qualifies disability in participants with Multiple Sclerosis. It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS).
Outcome measures
| Measure |
D-aspartate + IFN Beta-1a + Methylprednisolone
n=5 Participants
Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
Placebo + IFN Beta-1a + Methylprednisolone
n=2 Participants
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
|---|---|---|
|
Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 12 and 24
Week 12
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 12 and 24
Week 24
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Week 8, 12 and 24Population: Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, "number analyzed" signifies specific participant evaluated in respective arm at specified timepoint.
The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The participants is directed to one end of a clearly marked 25-foot (7.62 m) course and is instructed to walk 25 feet (7.62 meter) as quickly as possible, but safely. The task is immediately administered again by having the participant walk back the same distance. Participants may use assistive devices when doing this task. The test scores were the time in seconds it took to walk the 25 feet. The data for the 25-FWT is reported for the 2 completed trials. Participant wise data was reported for this outcome.
Outcome measures
| Measure |
D-aspartate + IFN Beta-1a + Methylprednisolone
n=5 Participants
Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
Placebo + IFN Beta-1a + Methylprednisolone
n=2 Participants
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
|---|---|---|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 1: Week 8
|
13.1 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 2: Week 8
|
12.4 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 2: Trial 1: Week 8
|
12.7 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 2: Trial 2: Week 8
|
12.6 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 1: Week 8
|
17.4 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 2: Week 8
|
16.3 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 1: Week 8
|
11.3 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 2: Week 8
|
10.9 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 1: Week 8
|
5.6 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 2: Week 8
|
5.7 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Trial 1: Week 8
|
—
|
16.1 Seconds
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Trial 2: Week 8
|
—
|
14.3 Seconds
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 1: Week 8
|
—
|
9.3 Seconds
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 2: Week 8
|
—
|
8.9 Seconds
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 1: Week 12
|
13.1 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 2: Week 12
|
13.8 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 1: Week 12
|
17.1 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 2: Week 12
|
15.8 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 1: Week 12
|
10.9 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 2: Week 12
|
10.2 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 1: Week 12
|
5.7 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 2: Week 12
|
5.6 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Trial 1: Week 12
|
—
|
12.7 Seconds
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Trial 2: Week 12
|
—
|
12.3 Seconds
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 1: Week 12
|
—
|
12.4 Seconds
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 2: Week 12
|
—
|
11.8 Seconds
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 1: Week 24
|
11.8 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 2: Week 24
|
11.5 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 1: Week 24
|
8.6 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 2: Week 24
|
9.3 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 1: Week 24
|
11.4 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 2: Week 24
|
11.5 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 1: Week 24
|
5.0 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 2: Week 24
|
5.3 Seconds
|
—
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 1: Week 24
|
—
|
10.1 Seconds
|
|
25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 2: Week 24
|
—
|
9.8 Seconds
|
SECONDARY outcome
Timeframe: Week 8, 12 and 24Population: Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, "number analyzed" signifies specific participant evaluated in respective arm at specified timepoint.
The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The data for the 29HPT is reported for the 2 completed trials. Participant wise data was reported for this outcome.
Outcome measures
| Measure |
D-aspartate + IFN Beta-1a + Methylprednisolone
n=5 Participants
Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
Placebo + IFN Beta-1a + Methylprednisolone
n=2 Participants
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
|---|---|---|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 1: Week 12: Dominant hand
|
—
|
31.6 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 1: Week 8: Dominant hand
|
22.1 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 2: Week 8: Dominant hand
|
21.1 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 2: Trial 1: Week 8: Dominant hand
|
18.7 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 2: Trial 2: Week 8: Dominant hand
|
17.6 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 1: Week 8: Dominant hand
|
19.7 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 2: Week 8: Dominant hand
|
16.3 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 1: Week 8: Dominant hand
|
17.8 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 2: Week 8: Dominant hand
|
17.2 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 1: Week 8: Dominant hand
|
22.6 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 2: Week 8: Dominant hand
|
25.5 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Trial 1: Week 8: Dominant hand
|
—
|
17.5 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Trial 2: Week 8: Dominant hand
|
—
|
17.2 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 1: Week 8: Dominant hand
|
—
|
31.9 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 2: Week 8: Dominant hand
|
—
|
9.5 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 1: Week 12: Dominant hand
|
24.2 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 2: Week 12: Dominant hand
|
22.0 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 1: Week 12: Dominant hand
|
17.6 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 2: Week 12: Dominant hand
|
17.8 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 1: Week 12: Dominant hand
|
16.8 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 2: Week 12: Dominant hand
|
16.1 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 1: Week 12: Dominant hand
|
25.3 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 2: Week 12: Dominant hand
|
23.2 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Trial 1: Week 12: Dominant hand
|
—
|
21.1 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Trial 2: Week 12: Dominant hand
|
—
|
17.9 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 2: Week 12: Dominant hand
|
—
|
29.8 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 1: Week 24: Dominant hand
|
22.0 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 2: Week 24: Dominant hand
|
21.5 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 1: Week 24: Dominant hand
|
18.8 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 2: Week 24: Dominant hand
|
18.1 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 1: Week 24: Dominant hand
|
17.2 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 2: Week 24: Dominant hand
|
16.7 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 1: Week 24: Dominant hand
|
27.4 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 2: Week 24: Dominant hand
|
24.6 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 1: Week 24: Dominant hand
|
—
|
32.6 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 2: Week 24: Dominant hand
|
—
|
30.8 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 1: Week 8: Non-Dominant hand
|
25.2 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 2: Week 8: Non-Dominant hand
|
25.3 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 2: Trial 1: Week 8: Non-Dominant hand
|
18.9 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 2: Trial 2: Week 8: Non-Dominant hand
|
17.3 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 1: Week 8: Non-Dominant hand
|
21.4 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 2: Week 8: Non-Dominant hand
|
20.7 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 1: Week 8: Non-Dominant hand
|
18.9 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 2: Week 8: Non-Dominant hand
|
19.7 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 1: Week 8: Non-Dominant hand
|
22.0 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 2: Week 8: Non-Dominant hand
|
20.8 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Trial 1: Week 8: Non-Dominant hand
|
—
|
19.5 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Trial 2: Week 8: Non-Dominant hand
|
—
|
19.9 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 1: Week 8: Non-Dominant hand
|
—
|
22.0 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 2: Week 8: Non-Dominant hand
|
—
|
21.1 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 1: Week 12: Non-Dominant hand
|
22.8 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 2: Week 12: Non-Dominant hand
|
19.8 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 1: Week 12: Non-Dominant hand
|
20.8 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 2: Week 12: Non-Dominant hand
|
22.5 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 1: Week 12: Non-Dominant hand
|
17.3 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 2: Week 12: Non-Dominant hand
|
17.5 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 1: Week 12: Non-Dominant hand
|
22.8 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 2: Week 12: Non-Dominant hand
|
23.7 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Trial 1: Week 12: Non-Dominant hand
|
—
|
20.6 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Trial 2: Week 12: Non-Dominant hand
|
—
|
20.4 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 1: Week 12: Non-Dominant hand
|
—
|
24.5 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 2: Week 12: Non-Dominant hand
|
—
|
25.7 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 1: Week 24: Non-Dominant hand
|
22.4 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Trial 2: Week 24: Non-Dominant hand
|
20.5 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 1: Week 24: Non-Dominant hand
|
20.1 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Trial 2: Week 24: Non-Dominant hand
|
18.4 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 1: Week 24: Non-Dominant hand
|
18.1 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Trial 2: Week 24: Non-Dominant hand
|
18.3 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 1: Week 24: Non-Dominant hand
|
25.8 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Trial 2: Week 24: Non-Dominant hand
|
22.7 Seconds
|
—
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 1: Week 24: Non-Dominant hand
|
—
|
24.1 Seconds
|
|
9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Trial 2: Week 24: Non-Dominant hand
|
—
|
23.6 Seconds
|
SECONDARY outcome
Timeframe: At Week 8, 12 and 24Population: Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, "number analyzed" signifies specific participant evaluated in respective arm at specified timepoint.
Symbol digit modalities test is to evaluate neurocognitive functions. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The participants is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the participants fills in the numbers that correspond to the symbols. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance. Participant wise data was reported for this outcome.
Outcome measures
| Measure |
D-aspartate + IFN Beta-1a + Methylprednisolone
n=5 Participants
Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
Placebo + IFN Beta-1a + Methylprednisolone
n=2 Participants
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
|---|---|---|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Week 8
|
38 units on a scale
|
—
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 2: Week 8
|
43 units on a scale
|
—
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Week 8
|
48 units on a scale
|
—
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Week 8
|
66 units on a scale
|
—
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Week 8
|
46 units on a scale
|
—
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Week 8
|
—
|
56 units on a scale
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Week 8
|
—
|
43 units on a scale
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Week 12
|
48 units on a scale
|
—
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Week 12
|
44 units on a scale
|
—
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Week 12
|
68 units on a scale
|
—
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Week 12
|
44 units on a scale
|
—
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Week 12
|
—
|
46 units on a scale
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Week 12
|
—
|
43 units on a scale
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Week 24
|
50 units on a scale
|
—
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Week 24
|
51 units on a scale
|
—
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Week 24
|
70 units on a scale
|
—
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 5: Week 24
|
39 units on a scale
|
—
|
|
Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Week 24
|
—
|
55 units on a scale
|
SECONDARY outcome
Timeframe: Week 8, 12 and 24Population: Full analysis set. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, "Number of participants analyzed" signifies those who were evaluable for this endpoint and "number analyzed" signifies specific participant evaluated in respective arm at specified timepoint.
Visual acuity is measured under low contrast conditions (10% contrast relative to the chart background) at object testing distances of 10 feets and is reported as the number of letters read correctly (ranging from 0 to 10 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. Participant wise data was reported for this outcome.
Outcome measures
| Measure |
D-aspartate + IFN Beta-1a + Methylprednisolone
n=8 eye
Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
Placebo + IFN Beta-1a + Methylprednisolone
n=4 eye
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
|---|---|---|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Week 8: Left eye
|
4 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 2: Week 8: Left eye
|
8 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Week 8: Left eye
|
8 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Week 8: Left eye
|
8 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Week 8: Left eye
|
—
|
8 Letters read correctly
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Week 8: Left eye
|
—
|
8 Letters read correctly
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Week 12: Left eye
|
2 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Week 12: Left eye
|
10 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Week 12: Left eye
|
8 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Week 12: Left eye
|
—
|
8 Letters read correctly
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Week 12: Left eye
|
—
|
9 Letters read correctly
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Week 24: Left eye
|
3 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Week 24: Left eye
|
10 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Week 24: Left eye
|
10 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Week 24: Left eye
|
—
|
8 Letters read correctly
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Week 8: Right eye
|
4 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 2: Week 8: Right eye
|
8 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Week 8: Right eye
|
2 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Week 8: Right eye
|
7 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Week 8: Right eye
|
—
|
8 Letters read correctly
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Week 8: Right eye
|
—
|
8 Letters read correctly
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Week 12: Right eye
|
8 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Week 12: Right eye
|
10 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Week 12: Right eye
|
7 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 6: Week 12: Right eye
|
—
|
8 Letters read correctly
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Week 12: Right eye
|
—
|
9 Letters read correctly
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 1: Week 24: Right eye
|
8 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 3: Week 24: Right eye
|
10 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 4: Week 24: Right eye
|
10 Letters read correctly
|
—
|
|
Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment
Participant 7: Week 24: Right eye
|
—
|
8 Letters read correctly
|
SECONDARY outcome
Timeframe: Week 8, 12 and 24Population: Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, "number analyzed" signifies specific participant evaluated in respective arm at specified timepoint.
MFIS is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on participant's activities. The Total MFIS score ranges from 0 to 84. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Participant wise data was reported for this outcome.
Outcome measures
| Measure |
D-aspartate + IFN Beta-1a + Methylprednisolone
n=5 Participants
Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
Placebo + IFN Beta-1a + Methylprednisolone
n=2 Participants
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
|---|---|---|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 1: Week 8
|
8 units on a scale
|
—
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 2: Week 8
|
27 units on a scale
|
—
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 3: Week 8
|
15 units on a scale
|
—
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 4: Week 8
|
2 units on a scale
|
—
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 5: Week 8
|
18 units on a scale
|
—
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 6: Week 8
|
—
|
27 units on a scale
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 7: Week 8
|
—
|
29 units on a scale
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 1: Week 12
|
6 units on a scale
|
—
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 3: Week 12
|
12 units on a scale
|
—
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 4: Week 12
|
12 units on a scale
|
—
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 5: Week 12
|
15 units on a scale
|
—
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 6: Week 12
|
—
|
27 units on a scale
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 7: Week 12
|
—
|
30 units on a scale
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 1: Week 24
|
10 units on a scale
|
—
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 3: Week 24
|
48 units on a scale
|
—
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 4: Week 24
|
12 units on a scale
|
—
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 5: Week 24
|
15 units on a scale
|
—
|
|
Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24
Participant 7: Week 24
|
—
|
43 units on a scale
|
SECONDARY outcome
Timeframe: Week 8, 12 and 24Population: Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, "number analyzed" signifies specific participant evaluated in respective arm at specified timepoint.
Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue. Participant wise data was reported for this outcome.
Outcome measures
| Measure |
D-aspartate + IFN Beta-1a + Methylprednisolone
n=5 Participants
Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
Placebo + IFN Beta-1a + Methylprednisolone
n=2 Participants
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
|---|---|---|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 4: Week 12
|
2 units on a scale
|
—
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 1: Week 8
|
1.2 units on a scale
|
—
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 2: Week 8
|
2.6 units on a scale
|
—
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 3: Week 8
|
1.7 units on a scale
|
—
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 4: Week 8
|
1.1 units on a scale
|
—
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 5: Week 8
|
1 units on a scale
|
—
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 6: Week 8
|
—
|
4.3 units on a scale
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 7: Week 8
|
—
|
2.2 units on a scale
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 1: Week 12
|
1.3 units on a scale
|
—
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 3: Week 12
|
2.6 units on a scale
|
—
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 5: Week 12
|
1 units on a scale
|
—
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 6: Week 12
|
—
|
4.1 units on a scale
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 7: Week 12
|
—
|
4.1 units on a scale
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 1: Week 24
|
1.3 units on a scale
|
—
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 3: Week 24
|
2.8 units on a scale
|
—
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 4: Week 24
|
2 units on a scale
|
—
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 5: Week 24
|
1.1 units on a scale
|
—
|
|
Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24
Participant 7: Week 24
|
—
|
3.3 units on a scale
|
SECONDARY outcome
Timeframe: Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8Population: Full analysis set. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, "Number of participants analyzed" signifies those who were evaluated for this endpoint and "number analyzed" signifies specific participant evaluated in respective arm.
TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motor neurons. Long term potentiation can be measured non invasively and painlessly, in awake humans through transcranial magnetic stimulation (TMS). TMS uses high intensity, brief duration, magnetic fields that, when applied on the scalp, can activate neurons within a small focal region of the cerebral cortex, through electromagnetic induction. Motor Evoked Potentials (MEP) amplitudes elicited by single TMS pulses of increasing intensity (110, 120 and 130% of the Resting Motor Threshold \[RMT\]) will be measured to calculate recruitment curves of the motor cortex. Participant wise data was reported for this outcome.
Outcome measures
| Measure |
D-aspartate + IFN Beta-1a + Methylprednisolone
n=2 Participants
Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
Placebo + IFN Beta-1a + Methylprednisolone
n=2 Participants
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
|---|---|---|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 1: Week 8 (Baseline): 110% RMT
|
30 millivolts
|
—
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 1: Week 8 (Baseline): 120% RMT
|
105 millivolts
|
—
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 1: Week 8 (Baseline): 130% RMT
|
142 millivolts
|
—
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 1: Week 8 (Post-baseline): 110% RMT
|
39 millivolts
|
—
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 1: Week 8 (Post-baseline): 120% RMT
|
128 millivolts
|
—
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 1: Week 8 (Post-baseline): 130% RMT
|
154 millivolts
|
—
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 3: Week 8 (Baseline): 110% RMT
|
23 millivolts
|
—
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 3: Week 8 (Baseline): 120% RMT
|
95 millivolts
|
—
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 3: Week 8 (Baseline): 130% RMT
|
115 millivolts
|
—
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 3: Week 8 (Post-baseline): 110% RMT
|
31 millivolts
|
—
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 3: Week 8 (Post-baseline): 120% RMT
|
103 millivolts
|
—
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 3: Week 8 (Post-baseline): 130% RMT
|
118 millivolts
|
—
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 6: Week 8 (Baseline): 110% RMT
|
—
|
28 millivolts
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 6: Week 8 (Baseline): 120% RMT
|
—
|
83 millivolts
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 6: Week 8 (Baseline): 130% RMT
|
—
|
118 millivolts
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 6: Week 8 (Post-baseline): 110% RMT
|
—
|
26 millivolts
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 6: Week 8 (Post-baseline): 120% RMT
|
—
|
91 millivolts
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 6: Week 8 (Post-baseline): 130% RMT
|
—
|
125 millivolts
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 7: Week 8 (Baseline): 110% RMT
|
—
|
33 millivolts
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 7: Week 8 (Baseline): 120% RMT
|
—
|
140 millivolts
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 7: Week 8 (Baseline): 130% RMT
|
—
|
149 millivolts
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 7: Week 8 (Post-baseline): 110% RMT
|
—
|
30 millivolts
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 7: Week 8 (Post-baseline): 120% RMT
|
—
|
135 millivolts
|
|
Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)
Participants 7: Week 8 (Post-baseline): 130% RMT
|
—
|
138 millivolts
|
SECONDARY outcome
Timeframe: Baseline, Week 8 and 12Population: Data was not collected since the study was prematurely terminated, due to slow recruitment rate.
Treated participants with immune-metabolic response (glycolysis, mitochondrial respiration, fatty acids oxidation and circulating adipocytokines) of lymphocytes were to be reported.
Outcome measures
Outcome data not reported
Adverse Events
D-aspartate + IFN Beta-1a + Methylprednisolone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo + IFN Beta-1a + Methylprednisolone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
D-aspartate + IFN Beta-1a + Methylprednisolone
n=5 participants at risk
Participants received D-aspartate 2660 milligrams (mg) once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
Placebo + IFN Beta-1a + Methylprednisolone
n=2 participants at risk
Participants received placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks along with IFN beta-1a subcutaneously (sc) at a dose of 44 microgram (mcg) three times a week (TIW) in participants without relapse and IFN beta-1a sc TIW plus Methylprednisolone 1000 mg intravenously once daily for 5 consecutive days in participants with relapse.
|
|---|---|---|
|
Reproductive system and breast disorders
Hypersexuality
|
20.0%
1/5 • Baseline up to 292 days; Participants were assessed for adverse events for the entire study
|
0.00%
0/2 • Baseline up to 292 days; Participants were assessed for adverse events for the entire study
|
|
Infections and infestations
Flu-like symptoms
|
20.0%
1/5 • Baseline up to 292 days; Participants were assessed for adverse events for the entire study
|
50.0%
1/2 • Baseline up to 292 days; Participants were assessed for adverse events for the entire study
|
|
General disorders
Weight gain
|
20.0%
1/5 • Baseline up to 292 days; Participants were assessed for adverse events for the entire study
|
0.00%
0/2 • Baseline up to 292 days; Participants were assessed for adverse events for the entire study
|
|
General disorders
Pain in the left thigh
|
20.0%
1/5 • Baseline up to 292 days; Participants were assessed for adverse events for the entire study
|
0.00%
0/2 • Baseline up to 292 days; Participants were assessed for adverse events for the entire study
|
|
Eye disorders
Periorbital pain
|
0.00%
0/5 • Baseline up to 292 days; Participants were assessed for adverse events for the entire study
|
50.0%
1/2 • Baseline up to 292 days; Participants were assessed for adverse events for the entire study
|
Additional Information
Communication Center
Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place