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Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury (ASCI)

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ClinicalTrials.gov Identifier: NCT01502631
Recruitment Status : Completed
First Posted : January 2, 2012
Results First Posted : January 15, 2021
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Spinal Cord Injury
Interventions Drug: SUN13837 injection
Drug: Placebo
Enrollment 65
Recruitment Details A total of 65 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 19 clinic sites in the United States of America, 2 in France, 1 in the United Kingdom,1 in Spain, and 1 in the Czech Republic. Four (4) of the participants were not treated. The data on the 61 treated participants are presented in this report.
Pre-assignment Details Participants with acute traumatic cervical spinal cord injury (ASCI) within 12 hours of treatment were enrolled in this study.
Arm/Group Title SUN13837 Placebo
Hide Arm/Group Description Participants with acute traumatic cervical spinal cord injury who were administered SUN13837 injection once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants). Participants with acute traumatic cervical spinal cord injury who were administered a placebo once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
Period Title: Overall Study
Started 30 31
Completed 10 11
Not Completed 20 20
Reason Not Completed
Adverse Event             5             8
Lost to Follow-up             2             2
Participant withdrew consent             2             4
Participant non-compliant             1             0
Investigator's decision             0             1
Other             10             5
Arm/Group Title SUN13837 Placebo Total
Hide Arm/Group Description Participants with acute traumatic cervical spinal cord injury who were administered SUN13837 injection once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants). Participants with acute traumatic cervical spinal cord injury who were administered a placebo once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants). Total of all reporting groups
Overall Number of Baseline Participants 30 31 61
Hide Baseline Analysis Population Description
Baseline characteristics were assessed in the Safety Population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 31 participants 61 participants
37.9  (16.6) 38.8  (17.2) 38.4  (16.8)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
< 55 years
25
  83.3%
25
  80.6%
50
  82.0%
≥ 55 years
5
  16.7%
6
  19.4%
11
  18.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
Female
4
  13.3%
5
  16.1%
9
  14.8%
Male
26
  86.7%
26
  83.9%
52
  85.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
Hispanic or Latino
1
   3.3%
2
   6.5%
3
   4.9%
Not Hispanic or Latino
29
  96.7%
26
  83.9%
55
  90.2%
Unknown or Not Reported
0
   0.0%
3
   9.7%
3
   4.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   6.7%
5
  16.1%
7
  11.5%
Native Hawaiian or Other Pacific Islander
2
   6.7%
1
   3.2%
3
   4.9%
Black or African American
4
  13.3%
5
  16.1%
9
  14.8%
White
22
  73.3%
17
  54.8%
39
  63.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
3
   9.7%
3
   4.9%
1.Primary Outcome
Title Total Spinal Cord Independence Measure, Version III (SCIM III) Score Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury
Hide Description The SCIM III is a comprehensive rating scale that measures the ability of participants with spinal cord injury to perform everyday tasks. The SCIM III has 19 items that assess 3 domains: Self-Care (6 items, scores range from 0 to 20), Respiration and Sphincter Management (4 items, scores range from 0 to 40), and Mobility (9 items, scores range from 0 to 40). The total SCIM score ranges from 0 to a maximum of 100 points in an individual with a fully functional spinal cord. A score of 0 indicates a worse outcome and a score of 100 indicates a better outcome. An improvement of at least 4 points of the total SCIM showed a small significant improvement, and 10 points showed a substantial improvement.
Time Frame Week 2, week 4, week 8 and week 16 post dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Total Spinal Cord Independence Measure was assessed in the intent-to-treat (ITT) population, defined as all randomized participants who had at least 1 SCIM III evaluation and received at least 7 (partial or complete) IV bolus dose injections of the study drug in SUN13837 group or in Placebo group.
Arm/Group Title SUN13837 Placebo
Hide Arm/Group Description:
Participants with acute traumatic cervical spinal cord injury who were administered SUN13837 injection once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
Participants with acute traumatic cervical spinal cord injury who were administered a placebo once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
Overall Number of Participants Analyzed 27 28
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Score on a scale
Week 2
15.87
(10.15 to 21.59)
10.26
(4.73 to 15.79)
Week 4
22.56
(15.65 to 29.47)
15.69
(8.87 to 22.51)
Week 8
28.77
(21.34 to 36.20)
25.74
(18.39 to 33.09)
Week 16
38.14
(30.14 to 46.14)
33.60
(25.67 to 41.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SUN13837, Placebo
Comments Difference (SUN13837 - Placebo) at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2182
Comments [Not Specified]
Method Mixed Model Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean
Estimated Value 5.61
Confidence Interval (2-Sided) 90%
-1.93 to 13.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.497
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SUN13837, Placebo
Comments Difference (SUN13837 - Placebo) at Week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2260
Comments [Not Specified]
Method Mixed Model Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean
Estimated Value 6.87
Confidence Interval (2-Sided) 90%
-2.54 to 16.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.583
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SUN13837, Placebo
Comments Difference (SUN13837 - Placebo) at Week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6184
Comments [Not Specified]
Method Mixed Model Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean
Estimated Value 3.03
Confidence Interval (2-Sided) 90%
-7.15 to 13.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.023
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection SUN13837, Placebo
Comments Difference (SUN13837 - Placebo) at Week 16
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4912
Comments [Not Specified]
Method Mixed Model Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean
Estimated Value 4.54
Confidence Interval (2-Sided) 90%
-6.48 to 15.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.524
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Sensitivity Analyses of Total Spinal Cord Independence Measure, Version III (SCIM III) Score at Week 16 by Treatment Group
Hide Description The SCIM III is a comprehensive rating scale that measures the ability of participants with spinal cord injury to perform everyday tasks. The SCIM III has 19 items that assess 3 domains: Self-Care (6 items, scores range from 0 to 20), Respiration and Sphincter Management (4 items, scores range from 0 to 40), and Mobility (9 items, scores range from 0 to 40). The total SCIM score ranges from 0 to a maximum of 100 points in an individual with a fully functional spinal cord. A score of 0 indicates a worse outcome and a score of 100 indicates a better outcome. An improvement of at least 4 points of the total SCIM showed a small significant improvement, and 10 points showed a substantial improvement.
Time Frame Week 16 post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Sensitivity analyses were assessed in the Intent-to-Treat (ITT) and Efficacy Evaluable (EE) populations. The EE Population consisted of all subjects in the ITT Population who did not have any major protocol violations that impacted efficacy and were observed for efficacy for at least 2 SCIM III evaluations.
Arm/Group Title SUN13837 Placebo
Hide Arm/Group Description:
Participants with acute traumatic cervical spinal cord injury who were administered SUN13837 injection once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
Participants with acute traumatic cervical spinal cord injury who were administered a placebo once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
Overall Number of Participants Analyzed 27 28
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Score on a scale
Primary (EE) Number Analyzed 24 participants 25 participants
38.25
(30.96 to 45.54)
30.48
(23.41 to 37.55)
LOCF (ITT) Number Analyzed 27 participants 28 participants
36.12
(28.60 to 43.64)
30.84
(23.38 to 38.30)
Multiple Imputation (ITT) Number Analyzed 27 participants 28 participants
37.96
(29.32 to 46.61)
32.17
(23.46 to 40.88)
Simple Multiple Imputation (ITT) Number Analyzed 27 participants 28 participants
38.49
(30.06 to 46.93)
32.00
(23.63 to 40.38)
3.Secondary Outcome
Title Change From Baseline of Total Motor Score (TMS) of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury
Hide Description TMS was the sum of the overall Upper Extremity Motor Score (UEMS) and the overall Lower Extremity Motor Score (LEMS) of ISNCSCI. The score on the scale runs from a minimum value of 0 to a maximum of 100 points in an individual with a fully functional spinal cord. A score of 0 indicates a worse outcome and a score of 100 indicates a better outcome. The UEMS was defined as the sum of the motor function scores in the cervical spinal segments C5, C6, C7, C8, and T1. A separate sum was obtained for the right and left sides (a maximum of 25 points each) and for an overall score (with a maximum score of 50). The LEMS was defined as the sum of the motor function scores in the spinal segments lumbar level 2, lumbar level 3, lumbar level 4, lumbar level 5, and sacral level 1. A separate sum was obtained for the right and left sides (a maximum of 25 points each) and for an overall score (with a maximum score of 50).
Time Frame Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Total Motor Score (TMS) was assessed in the intent-to-treat (ITT) population, defined as all randomized participants who had at least 1 SCIM III evaluation and received at least 7 (partial or complete) IV bolus dose injections of the study drug in SUN13837 group or in Placebo group.
Arm/Group Title SUN13837 Placebo
Hide Arm/Group Description:
Participants with acute traumatic cervical spinal cord injury who were administered SUN13837 injection once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
Participants with acute traumatic cervical spinal cord injury who were administered a placebo once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
Overall Number of Participants Analyzed 27 28
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Units on a scale
Day 3
5.84
(1.56 to 10.12)
1.20
(-2.95 to 5.35)
Week 2
8.66
(3.55 to 13.77)
4.04
(-0.89 to 8.97)
Week 4
11.96
(6.19 to 17.72)
6.35
(0.75 to 11.95)
Week 8
14.81
(8.06 to 21.57)
11.31
(4.69 to 17.93)
Week 16
16.58
(9.40 to 23.76)
14.07
(7.06 to 21.09)
4.Secondary Outcome
Title Self-Care and Mobility Subscale Scores of Spinal Cord Independence Measure, Version III (SCIM III) Score Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury
Hide Description The SCIM III is a comprehensive rating scale that measures the ability of participants with spinal cord injury to perform everyday tasks. The SCIM III has 19 items that assess 3 domains, two of which are Self-care and Mobility. The self-care domain is a subscale of 6 items and scores range from 0 to 20 (higher scores indicate a better outcome). The mobility domain consists of 9 items with subscale scores range from 0 to 40 (higher scores indicate a better outcome). The score for the combined Self-Care and Mobility subscale ranges from 0 - 60 points; higher scores indicate a better outcome
Time Frame Week 2, Week 4, Week 8, and Week 16 post dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Self-Care and Mobility Subscale Scores were assessed in the intent-to-treat (ITT) population, defined as all randomized participants who had at least 1 SCIM III evaluation and received at least 7 (partial or complete) IV bolus dose injections of the study drug in SUN13837 group or in Placebo group.
Arm/Group Title SUN13837 Placebo
Hide Arm/Group Description:
Participants with acute traumatic cervical spinal cord injury who were administered SUN13837 injection once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
Participants with acute traumatic cervical spinal cord injury who were administered a placebo once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
Overall Number of Participants Analyzed 27 28
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Score on a scale
Week 2
5.76
(2.05 to 9.47)
3.77
(0.18 to 7.35)
Week 4
9.18
(4.81 to 13.56)
6.45
(2.14 to 10.77)
Week 8
14.70
(9.87 to 19.53)
11.25
(6.47 to 16.03)
Week 16
18.73
(13.43 to 24.03)
15.02
(9.77 to 20.27)
5.Secondary Outcome
Title Upper Extremity Motor Scores (UEMS) of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord
Hide Description The UEMS was defined as the sum of the motor function scores in the cervical spinal segments C5, C6, C7, C8, and T1. A separate sum was obtained for the right and left sides (a maximum of 25 points each) and an overall score of 0-50 with a maximum score of 50. A higher score indicates a better outcome.
Time Frame Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Upper Extremity Motor Scores (UEMS) were assessed in the intent-to-treat (ITT) population, defined as all randomized participants who had at least 1 SCIM III evaluation and received at least 7 (partial or complete) IV bolus dose injections of the study drug in SUN13837 group or in Placebo group.
Arm/Group Title SUN13837 Placebo
Hide Arm/Group Description:
Participants with acute traumatic cervical spinal cord injury who were administered SUN13837 injection once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
Participants with acute traumatic cervical spinal cord injury who were administered a placebo once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
Overall Number of Participants Analyzed 27 28
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Units on a scale
Day 3
2.08
(-0.14 to 4.31)
-1.24
(-3.45 to 0.98)
Week 2
3.98
(1.50 to 6.46)
0.59
(-1.83 to 3.02)
Week 4
5.95
(3.40 to 8.50)
1.73
(-0.79 to 4.24)
Week 8
8.66
(5.94 to 11.38)
3.83
(1.12 to 6.54)
Week 16
9.92
(7.10 to 12.74)
4.95
(2.17 to 7.73)
6.Secondary Outcome
Title Lower Extremity Motor Scores (LEMS) of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury
Hide Description The LEMS was defined as the sum of the motor function scores in the spinal segments lumbar level 2, lumbar level 3, lumbar level 4, lumbar level 5, and sacral level 1. A separate sum was obtained for the right and left sides (a maximum of 25 points each) and for an overall score with a maximum score of 50. A higher score indicates a better outcome.
Time Frame Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose.
Hide Outcome Measure Data
Hide Analysis Population Description
Lower Extremity Motor Scores (LEMS) were assessed in the intent-to-treat (ITT) population, defined as all randomized participants who had at least 1 SCIM III evaluation and received at least 7 (partial or complete) IV bolus dose injections of the study drug in SUN13837 group or in Placebo group.
Arm/Group Title SUN13837 Placebo
Hide Arm/Group Description:
Participants with acute traumatic cervical spinal cord injury who were administered SUN13837 injection once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
Participants with acute traumatic cervical spinal cord injury who were administered a placebo once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
Overall Number of Participants Analyzed 27 28
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Units on a scale
Day 3
2.71
(0.15 to 5.28)
3.22
(0.75 to 5.68)
Week 2
3.66
(0.94 to 6.38)
4.28
(1.67 to 6.88)
Week 4
4.89
(1.82 to 7.96)
5.36
(2.41 to 8.31)
Week 8
5.08
(1.22 to 8.94)
8.30
(4.53 to 12.08)
Week 16
6.13
(1.80 to 10.46)
9.96
(5.73 to 14.20)
7.Secondary Outcome
Title Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury
Hide Description The protocol defined an adverse event (AE) as any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Baseline up to approximately Day 182 post dose.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was used to assess adverse events.
Arm/Group Title SUN13837 Placebo
Hide Arm/Group Description:
Participants with acute traumatic cervical spinal cord injury who were administered SUN13837 injection once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
Participants with acute traumatic cervical spinal cord injury who were administered a placebo once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
Overall Number of Participants Analyzed 30 31
Measure Type: Count of Participants
Unit of Measure: Participants
Urinary tract infection
21
  70.0%
23
  74.2%
Pyrexia
17
  56.7%
14
  45.2%
Decubitus ulcer
13
  43.3%
13
  41.9%
Insomnia
14
  46.7%
12
  38.7%
Pneumonia
9
  30.0%
17
  54.8%
Nausea
12
  40.0%
10
  32.3%
Muscle spasticity
12
  40.0%
9
  29.0%
Neuralgia
13
  43.3%
8
  25.8%
Anxiety
9
  30.0%
10
  32.3%
Constipation
7
  23.3%
11
  35.5%
Leukocytosis
8
  26.7%
10
  32.3%
Depression
8
  26.7%
9
  29.0%
Musculoskeletal pain
10
  33.3%
7
  22.6%
Orthostatic hypotension
9
  30.0%
8
  25.8%
Anaemia
5
  16.7%
11
  35.5%
Respiratory failure
8
  26.7%
7
  22.6%
Muscle spasms
8
  26.7%
6
  19.4%
Headache
9
  30.0%
4
  12.9%
Rash
9
  30.0%
4
  12.9%
Blood creatine phosphokinase increased
7
  23.3%
5
  16.1%
Time Frame Baseline up to approximately Day 182 post dose.
Adverse Event Reporting Description The protocol defined an adverse event (AE) as any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Serious AEs are summarized across the on-treatment and off-treatment periods by descending order in the SUN13837 group.
 
Arm/Group Title SUN13837 Placebo
Hide Arm/Group Description Participants with acute traumatic cervical spinal cord injury who were administered SUN13837 injection once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants). Participants with acute traumatic cervical spinal cord injury who were administered a placebo once daily for at least 7 but no more than 28 consecutive days (except for the dose interval between the first and second doses, which may have occurred on the same day [dosing to 27 days] in certain participants).
All-Cause Mortality
SUN13837 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/30 (6.67%)   2/31 (6.45%) 
Hide Serious Adverse Events
SUN13837 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   21/30 (70.00%)   23/31 (74.19%) 
Blood and lymphatic system disorders     
Anaemia  1  5/30 (16.67%)  11/31 (35.48%) 
Cardiac disorders     
Arrhythmia  1  1/30 (3.33%)  0/31 (0.00%) 
Bradycardia  1  1/30 (3.33%)  2/31 (6.45%) 
Cardiac arrest  1  1/30 (3.33%)  1/31 (3.23%) 
Endocrine disorders     
Thyroiditis  1  1/30 (3.33%)  0/31 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal haemorrhage  1  1/30 (3.33%)  0/31 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/30 (0.00%)  1/31 (3.23%) 
Nausea  1  12/30 (40.00%)  10/31 (32.26%) 
Constipation  1  7/30 (23.33%)  11/31 (35.48%) 
General disorders     
Chest pain  1  1/30 (3.33%)  0/31 (0.00%) 
Euthanasia  1  0/30 (0.00%)  1/31 (3.23%) 
Hepatobiliary disorders     
Cholecystitis  1  0/30 (0.00%)  1/31 (3.23%) 
Infections and infestations     
Escherichia urinary tract infection  1  0/30 (0.00%)  1/31 (3.23%) 
Lower respiratory tract infection  1  0/30 (0.00%)  1/31 (3.23%) 
Lung infection pseudomonal  1  1/30 (3.33%)  0/31 (0.00%) 
Pneumonia  1  3/30 (10.00%)  1/31 (3.23%) 
Pneumonia streptococcal  1  0/30 (0.00%)  1/31 (3.23%) 
Sepsis  1  1/30 (3.33%)  0/31 (0.00%) 
Urinary tract infection  1  21/30 (70.00%)  23/31 (74.19%) 
Urinary tract infection fungal  1  0/30 (0.00%)  1/31 (3.23%) 
Pneumonia  1  9/30 (30.00%)  17/31 (54.84%) 
Investigations     
Electrocardiogram QT prolonged  1  1/30 (3.33%)  1/31 (3.23%) 
Hepatic enzyme increased  1  2/30 (6.67%)  1/31 (3.23%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  8/30 (26.67%)  6/31 (19.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Multiple myeloma  1  0/30 (0.00%)  1/31 (3.23%) 
Nervous system disorders     
Convulsion  1  0/30 (0.00%)  1/31 (3.23%) 
Ischaemic stroke  1  0/30 (0.00%)  1/31 (3.23%) 
Presyncope  1  0/30 (0.00%)  1/31 (3.23%) 
Muscle spasticity  1  12/30 (40.00%)  9/31 (29.03%) 
Neuralgia  1  13/30 (43.33%)  8/31 (25.81%) 
Headache  1  9/30 (30.00%)  4/31 (12.90%) 
Psychiatric disorders     
Insomnia  1  14/30 (46.67%)  12/31 (38.71%) 
Anxiety  1  9/30 (30.00%)  10/31 (32.26%) 
Renal and urinary disorders     
Anuria  1  1/30 (3.33%)  0/31 (0.00%) 
Pyuria  1  0/30 (0.00%)  1/31 (3.23%) 
Renal failure acute  1  1/30 (3.33%)  1/31 (3.23%) 
Urine abnormality  1  0/30 (0.00%)  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  0/30 (0.00%)  1/31 (3.23%) 
Hypercapnia  1  1/30 (3.33%)  0/31 (0.00%) 
Hypoxia  1  1/30 (3.33%)  0/31 (0.00%) 
Pleural effusion  1  1/30 (3.33%)  1/31 (3.23%) 
Pneumonia aspiration  1  1/30 (3.33%)  0/31 (0.00%) 
Pulmonary embolism  1  3/30 (10.00%)  0/31 (0.00%) 
Respiratory distress  1  1/30 (3.33%)  0/31 (0.00%) 
Respiratory failure  1  8/30 (26.67%)  7/31 (22.58%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  13/30 (43.33%)  13/31 (41.94%) 
Rash  1  9/30 (30.00%)  4/31 (12.90%) 
Surgical and medical procedures     
Withdrawal of life support  1  0/30 (0.00%)  1/31 (3.23%) 
Vascular disorders     
Deep vein thrombosis  1  1/30 (3.33%)  1/31 (3.23%) 
Hypotension  1  0/30 (0.00%)  1/31 (3.23%) 
Orthostatic hypotension  1  9/30 (30.00%)  8/31 (25.81%) 
1
Term from vocabulary, MedDRA (15.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
SUN13837 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   14/30 (46.67%)   20/31 (64.52%) 
Blood and lymphatic system disorders     
Anaemia  1  1/30 (3.33%)  0/31 (0.00%) 
Leukocytosis  1  0/30 (0.00%)  1/31 (3.23%) 
Cardiac disorders     
Arrhythmia  1  1/30 (3.33%)  0/31 (0.00%) 
Cardiac arrest  1  1/30 (3.33%)  1/31 (3.23%) 
Bradycardia  1  0/30 (0.00%)  1/31 (3.23%) 
Gastrointestinal disorders     
Gastrointestinal haemorrhage  1  1/30 (3.33%)  0/31 (0.00%) 
Duodenal ulcer  1  1/30 (3.33%)  0/31 (0.00%) 
Neurogenic bowel  1  1/30 (3.33%)  0/31 (0.00%) 
Abdominal pain upper  1  0/30 (0.00%)  1/31 (3.23%) 
Dysphagia  1  0/30 (0.00%)  1/31 (3.23%) 
General disorders     
Pyrexia  1  2/30 (6.67%)  1/31 (3.23%) 
Pain  1  1/30 (3.33%)  0/31 (0.00%) 
Euthanasia  1  0/30 (0.00%)  1/31 (3.23%) 
Hepatobiliary disorders     
Cholecystitis  1  0/30 (0.00%)  1/31 (3.23%) 
Infections and infestations     
Sepsis  1  1/30 (3.33%)  0/31 (0.00%) 
Investigations     
Blood creatine phosphokinase increased  1  2/30 (6.67%)  1/31 (3.23%) 
C-reactive protein increased  1  1/30 (3.33%)  0/31 (0.00%) 
Alanin aminotransferase increased  1  0/30 (0.00%)  1/31 (3.23%) 
Aspartate aminotransferase increase  1  0/30 (0.00%)  1/31 (3.23%) 
Hepatic enzyme increased  1  0/30 (0.00%)  1/31 (3.23%) 
Metabolism and nutrition disorders     
Hyponatraemia  1  1/30 (3.33%)  0/31 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain  1  1/30 (3.33%)  1/31 (3.23%) 
Neck pain  1  1/30 (3.33%)  0/31 (0.00%) 
Extremity contracture  1  0/30 (0.00%)  1/31 (3.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Multiple myeloma  1  0/30 (0.00%)  1/31 (3.23%) 
Nervous system disorders     
Neurogenic bladder  1  2/30 (6.67%)  0/31 (0.00%) 
Pseudomeningocele  1  1/30 (3.33%)  0/31 (0.00%) 
Ischaemic stroke  1  0/30 (0.00%)  1/31 (3.23%) 
Presyncope  1  0/30 (0.00%)  1/31 (3.23%) 
Spinal cord compression  1  0/30 (0.00%)  1/31 (3.23%) 
Spinal cord oedema  1  0/30 (0.00%)  1/31 (3.23%) 
Psychiatric disorders     
Confusional state  1  1/30 (3.33%)  0/31 (0.00%) 
Depression  1  0/30 (0.00%)  1/31 (3.23%) 
Renal and urinary disorders     
Anuria  1  1/30 (3.33%)  0/31 (0.00%) 
Renal failure acute  1  1/30 (3.33%)  0/31 (0.00%) 
Urinary tract infection  1  0/30 (0.00%)  3/31 (9.68%) 
Autonomic dysreflexia  1  0/30 (0.00%)  2/31 (6.45%) 
Urinary retention  1  0/30 (0.00%)  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  4/30 (13.33%)  3/31 (9.68%) 
Pulmonary embolism  1  2/30 (6.67%)  0/31 (0.00%) 
Atelectasis  1  1/30 (3.33%)  2/31 (6.45%) 
Dyspnoea  1  1/30 (3.33%)  1/31 (3.23%) 
Hypercapnia  1  1/30 (3.33%)  0/31 (0.00%) 
Pleural effusion  1  1/30 (3.33%)  0/31 (0.00%) 
Pneumonia aspiration  1  1/30 (3.33%)  0/31 (0.00%) 
Respiratory distress  1  1/30 (3.33%)  0/31 (0.00%) 
Tachypnoea  1  1/30 (3.33%)  0/31 (0.00%) 
Lower respiratory tract infection  1  0/30 (0.00%)  1/31 (3.23%) 
Acute respiratory failure  1  0/30 (0.00%)  1/31 (3.23%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  1/30 (3.33%)  1/31 (3.23%) 
Skin ulcer  1  1/30 (3.33%)  1/31 (3.23%) 
Pruritus  1  0/30 (0.00%)  1/31 (3.23%) 
Osteosynthesis  1  0/30 (0.00%)  1/31 (3.23%) 
Surgical and medical procedures     
Withdrawal of life support  1  0/30 (0.00%)  1/31 (3.23%) 
Vascular disorders     
Deep vein thrombosis  1  0/30 (0.00%)  1/31 (3.23%) 
Hypotension  1  0/30 (0.00%)  1/31 (3.23%) 
1
Term from vocabulary, MedDRA (15.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Contact for Clinical Trial Information
Organization: Daiichi Sankyo
Phone: 908-992-6400
EMail: CTRinfo@dsi.com
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT01502631    
Other Study ID Numbers: ASBI 603
First Submitted: December 27, 2011
First Posted: January 2, 2012
Results First Submitted: December 10, 2020
Results First Posted: January 15, 2021
Last Update Posted: January 15, 2021