Trial Outcomes & Findings for Study of SPARC1103 in Subjects With Spasticity (NCT NCT02027025)
NCT ID: NCT02027025
Last Updated: 2019-05-03
Results Overview
The modified Ashworth scale is a 6-point scale as follows: Minimum score of 0 (better outcome) = no increase in tone Maximum score of 4 (worst outcome) = affected part(s) rigid in flexion or extension For calculation of modified Ashworth Score, the following scores were assigned to each category of modified Ashworth scale: not testable=NA, 0=0 units, 1=1 unit, 1+ = 2 units, 2 = 3 units, and 4 = 5 units. The total score was the sum of the scores of the 6 lower extremity muscle groups on both left and right sides (range = o0 to 60).
COMPLETED
PHASE2
142 participants
Baseline, Day 24
2019-05-03
Participant Flow
Participant milestones
| Measure |
SPARC1103 Low Dose
SPARC1103 low dose dosing regimen:
1 capsule orally, approximately 30 minutes
|
SPARC1103 High Dose
SPARC1103 high dose dosing regimen
1 capsule orally, approximately 30 minutes
|
SPARC Placebo
SPARC Placebo dosing regimen
1 capsule orally, approximately 30 minutes
|
|---|---|---|---|
|
Overall Study
STARTED
|
48
|
47
|
47
|
|
Overall Study
COMPLETED
|
47
|
42
|
46
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
1
|
Reasons for withdrawal
| Measure |
SPARC1103 Low Dose
SPARC1103 low dose dosing regimen:
1 capsule orally, approximately 30 minutes
|
SPARC1103 High Dose
SPARC1103 high dose dosing regimen
1 capsule orally, approximately 30 minutes
|
SPARC Placebo
SPARC Placebo dosing regimen
1 capsule orally, approximately 30 minutes
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Sponsor's decision
|
0
|
1
|
0
|
Baseline Characteristics
Study of SPARC1103 in Subjects With Spasticity
Baseline characteristics by cohort
| Measure |
SPARC1103 Low Dose
n=48 Participants
Age: 50.5 (9.12)
|
SPARC1103 High Dose
n=47 Participants
Age: 52.3 (9.33)
|
SPARC Placebo
n=47 Participants
Age: 50.2 (10.43)
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 9.12 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 9.33 • n=7 Participants
|
50.2 years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
51.0 years
STANDARD_DEVIATION 9.62 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
124 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
47 participants
n=7 Participants
|
47 participants
n=5 Participants
|
142 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 24Population: Intent to treat population: SPARC1103 low dose, N=47; SPARC 1103 high hose, N=42; and Placebo, N=46
The modified Ashworth scale is a 6-point scale as follows: Minimum score of 0 (better outcome) = no increase in tone Maximum score of 4 (worst outcome) = affected part(s) rigid in flexion or extension For calculation of modified Ashworth Score, the following scores were assigned to each category of modified Ashworth scale: not testable=NA, 0=0 units, 1=1 unit, 1+ = 2 units, 2 = 3 units, and 4 = 5 units. The total score was the sum of the scores of the 6 lower extremity muscle groups on both left and right sides (range = o0 to 60).
Outcome measures
| Measure |
SPARC1103 Low Dose
n=47 Participants
Least square mean difference (Placebo versus SPARC 1103 low dose) in change from baseline in total modified Ashworth score on day 24
|
SPARC1103 High Dose
n=42 Participants
Least square mean difference (Placebo versus SPARC 1103 high dose) in change from baseline in total modified Ashworth score on day 24
|
SPARC Placebo
Change from baseline for nighttime awakening score on day 24
|
|---|---|---|---|
|
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score
|
0.33 score on a scale
Standard Error 1.47
|
0.03 score on a scale
Standard Error 1.53
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 24Population: Intent to treat population: SPARC 1103 low dose, N=47; SPARC 1103 high dose, N=42; and Placebo N=46.
Nighttime awakening score was assessed as follows: The subject was asked the following question on the morning of Day 24: How many times did you wake up last night due to spasticity? Score range from "0" (better score) to "infinity" (worse score)
Outcome measures
| Measure |
SPARC1103 Low Dose
n=47 Participants
Least square mean difference (Placebo versus SPARC 1103 low dose) in change from baseline in total modified Ashworth score on day 24
|
SPARC1103 High Dose
n=42 Participants
Least square mean difference (Placebo versus SPARC 1103 high dose) in change from baseline in total modified Ashworth score on day 24
|
SPARC Placebo
n=46 Participants
Change from baseline for nighttime awakening score on day 24
|
|---|---|---|---|
|
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Night Time Awakening Score
|
-0.25 Awakenings
Standard Error 0.449
|
-0.24 Awakenings
Standard Error 0.470
|
0.23 Awakenings
Standard Error 0.449
|
SECONDARY outcome
Timeframe: Baseline, Day 24Population: Intent to treat population: SPARC 1103 low dose, N= 47; SPARC1103 High dose, N=42; and Placebo, N=46
Spasm frequency was assessed using following 4-point scale as follows: Minimum score of 0 (better outcome))=no spasm Maximum score of 4 (worst outcome)=Spasms occurring more than 10 times per hour
Outcome measures
| Measure |
SPARC1103 Low Dose
n=47 Participants
Least square mean difference (Placebo versus SPARC 1103 low dose) in change from baseline in total modified Ashworth score on day 24
|
SPARC1103 High Dose
n=42 Participants
Least square mean difference (Placebo versus SPARC 1103 high dose) in change from baseline in total modified Ashworth score on day 24
|
SPARC Placebo
n=46 Participants
Change from baseline for nighttime awakening score on day 24
|
|---|---|---|---|
|
Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Spasm Frequency
|
-0.46 score on a scale
Standard Error 0.129
|
-0.46 score on a scale
Standard Error 0.140
|
-2.6 score on a scale
Standard Error 0.133
|
SECONDARY outcome
Timeframe: Baseline, Day 24Population: Intent to treat population: SPARC 1103 low dose, N=47; SPARC 1103 high dose, N=42; and Placebo N=46
The clinician (other than the one performing the Modified Ashworth Scale assessment) rated his/her overall (global) impression of change in spasticity using the 7-point scale shown below: Minimum score of 1 (better outcome) = very much improved Maximum score of 7 (very much worse) = very much worse
Outcome measures
| Measure |
SPARC1103 Low Dose
n=47 Participants
Least square mean difference (Placebo versus SPARC 1103 low dose) in change from baseline in total modified Ashworth score on day 24
|
SPARC1103 High Dose
n=42 Participants
Least square mean difference (Placebo versus SPARC 1103 high dose) in change from baseline in total modified Ashworth score on day 24
|
SPARC Placebo
n=46 Participants
Change from baseline for nighttime awakening score on day 24
|
|---|---|---|---|
|
Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24
CGIC - minimally worse
|
3 participants
|
5 participants
|
2 participants
|
|
Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24
CGIC - much worse
|
1 participants
|
1 participants
|
0 participants
|
|
Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24
CGIC - very much improved
|
4 participants
|
2 participants
|
3 participants
|
|
Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24
CGIC - much improved
|
12 participants
|
8 participants
|
8 participants
|
|
Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24
CGIC - minimally improved
|
16 participants
|
20 participants
|
26 participants
|
|
Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24
CGIC - no change
|
11 participants
|
6 participants
|
7 participants
|
|
Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24
CGIC - very much worse
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Day 24Population: Intent to treat population: SPARC1103 low dose, N=47; SPARC1103 high dose, N=42; and Placebo, N=46
The subject was asked "Overall, how would you rate the severity of your spasticity over the past 24 hours?" The 7-point scale for Subject's global impression of severity assessment is as follows: minimum score of 1 = normal, no spasticity maximum score of 7 (worst outcome)= worst spasticity imaginable
Outcome measures
| Measure |
SPARC1103 Low Dose
n=47 Participants
Least square mean difference (Placebo versus SPARC 1103 low dose) in change from baseline in total modified Ashworth score on day 24
|
SPARC1103 High Dose
n=42 Participants
Least square mean difference (Placebo versus SPARC 1103 high dose) in change from baseline in total modified Ashworth score on day 24
|
SPARC Placebo
n=46 Participants
Change from baseline for nighttime awakening score on day 24
|
|---|---|---|---|
|
Subject Global Impression of Severity of Spasticity
Normal - no spasticity
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Subject Global Impression of Severity of Spasticity
Borderline spasticity
|
4 Participants
|
5 Participants
|
6 Participants
|
|
Subject Global Impression of Severity of Spasticity
Mild spasticity
|
15 Participants
|
19 Participants
|
15 Participants
|
|
Subject Global Impression of Severity of Spasticity
Moderate spasticity
|
19 Participants
|
12 Participants
|
18 Participants
|
|
Subject Global Impression of Severity of Spasticity
Marked spasticity
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Subject Global Impression of Severity of Spasticity
Severe spasticity
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Subject Global Impression of Severity of Spasticity
Worst spasticity imaginable
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
SPARC1103 Low Dose
SPARC1103 High Dose
SPARC Placebo
Serious adverse events
| Measure |
SPARC1103 Low Dose
n=48 participants at risk
Subjects with treatment emergent adverse events
|
SPARC1103 High Dose
n=47 participants at risk
Subjects with treatment emergent adverse events
|
SPARC Placebo
n=47 participants at risk
Subjects with treatment emergent adverse events
|
|---|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/48 • Screening through Day 24
|
2.1%
1/47 • Screening through Day 24
|
0.00%
0/47 • Screening through Day 24
|
Other adverse events
| Measure |
SPARC1103 Low Dose
n=48 participants at risk
Subjects with treatment emergent adverse events
|
SPARC1103 High Dose
n=47 participants at risk
Subjects with treatment emergent adverse events
|
SPARC Placebo
n=47 participants at risk
Subjects with treatment emergent adverse events
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.2%
2/48 • Screening through Day 24
|
4.3%
2/47 • Screening through Day 24
|
0.00%
0/47 • Screening through Day 24
|
|
Nervous system disorders
headache
|
4.2%
2/48 • Screening through Day 24
|
0.00%
0/47 • Screening through Day 24
|
0.00%
0/47 • Screening through Day 24
|
Additional Information
Mudgal Kothekar
Sun Pharma Advanced Research Company Limited
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place