Trial Outcomes & Findings for Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury (ASCI) (NCT NCT01502631)

Last Updated: 2021-01-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

65 participants

Primary outcome timeframe

Week 2, week 4, week 8 and week 16 post dose.

Results posted on

2021-01-15

Participant Flow

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.

Participants with acute traumatic cervical spinal cord injury (ASCI) within 12 hours of treatment were enrolled in this study.

Participant milestones

Participant milestones
Measure	SUN13837 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).	Placebo 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 Study STARTED	30	31
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	20	20

Reasons for withdrawal

Reasons for withdrawal
Measure	SUN13837 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).	Placebo 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 Study Adverse Event	5	8
Overall Study Lost to Follow-up	2	2
Overall Study Participant withdrew consent	2	4
Overall Study Participant non-compliant	1	0
Overall Study Investigator's decision	0	1
Overall Study Other	10	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SUN13837 n=30 Participants 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).	Placebo n=31 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 n=61 Participants Total of all reporting groups
Age, Continuous	37.9 years STANDARD_DEVIATION 16.6 • n=5 Participants	38.8 years STANDARD_DEVIATION 17.2 • n=7 Participants	38.4 years STANDARD_DEVIATION 16.8 • n=5 Participants
Age, Customized < 55 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Customized ≥ 55 years	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 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	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	17 Participants n=7 Participants	39 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	3 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 2, week 4, week 8 and week 16 post dose.

Population: 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.

Outcome measures

Outcome measures
Measure	SUN13837 n=27 Participants 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).	Placebo n=28 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 Spinal Cord Independence Measure, Version III (SCIM III) Score Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Week 2	15.87 Score on a scale Interval 10.15 to 21.59	10.26 Score on a scale Interval 4.73 to 15.79
Total Spinal Cord Independence Measure, Version III (SCIM III) Score Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Week 4	22.56 Score on a scale Interval 15.65 to 29.47	15.69 Score on a scale Interval 8.87 to 22.51
Total Spinal Cord Independence Measure, Version III (SCIM III) Score Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Week 8	28.77 Score on a scale Interval 21.34 to 36.2	25.74 Score on a scale Interval 18.39 to 33.09
Total Spinal Cord Independence Measure, Version III (SCIM III) Score Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Week 16	38.14 Score on a scale Interval 30.14 to 46.14	33.60 Score on a scale Interval 25.67 to 41.53

SECONDARY outcome

Timeframe: Week 16 post dose

Population: 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.

Outcome measures

Outcome measures
Measure	SUN13837 n=27 Participants 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).	Placebo n=28 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).
Sensitivity Analyses of Total Spinal Cord Independence Measure, Version III (SCIM III) Score at Week 16 by Treatment Group Primary (EE)	38.25 Score on a scale Interval 30.96 to 45.54	30.48 Score on a scale Interval 23.41 to 37.55
Sensitivity Analyses of Total Spinal Cord Independence Measure, Version III (SCIM III) Score at Week 16 by Treatment Group LOCF (ITT)	36.12 Score on a scale Interval 28.6 to 43.64	30.84 Score on a scale Interval 23.38 to 38.3
Sensitivity Analyses of Total Spinal Cord Independence Measure, Version III (SCIM III) Score at Week 16 by Treatment Group Multiple Imputation (ITT)	37.96 Score on a scale Interval 29.32 to 46.61	32.17 Score on a scale Interval 23.46 to 40.88
Sensitivity Analyses of Total Spinal Cord Independence Measure, Version III (SCIM III) Score at Week 16 by Treatment Group Simple Multiple Imputation (ITT)	38.49 Score on a scale Interval 30.06 to 46.93	32.00 Score on a scale Interval 23.63 to 40.38

SECONDARY outcome

Timeframe: Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose.

Population: 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.

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).

Outcome measures

Outcome measures
Measure	SUN13837 n=27 Participants 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).	Placebo n=28 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).
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 Day 3	5.84 Units on a scale Interval 1.56 to 10.12	1.20 Units on a scale Interval -2.95 to 5.35
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 Week 2	8.66 Units on a scale Interval 3.55 to 13.77	4.04 Units on a scale Interval -0.89 to 8.97
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 Week 4	11.96 Units on a scale Interval 6.19 to 17.72	6.35 Units on a scale Interval 0.75 to 11.95
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 Week 8	14.81 Units on a scale Interval 8.06 to 21.57	11.31 Units on a scale Interval 4.69 to 17.93
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 Week 16	16.58 Units on a scale Interval 9.4 to 23.76	14.07 Units on a scale Interval 7.06 to 21.09

SECONDARY outcome

Timeframe: Week 2, Week 4, Week 8, and Week 16 post dose.

Population: 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.

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

Outcome measures

Outcome measures
Measure	SUN13837 n=27 Participants 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).	Placebo n=28 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).
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 Week 8	14.70 Score on a scale Interval 9.87 to 19.53	11.25 Score on a scale Interval 6.47 to 16.03
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 Week 2	5.76 Score on a scale Interval 2.05 to 9.47	3.77 Score on a scale Interval 0.18 to 7.35
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 Week 4	9.18 Score on a scale Interval 4.81 to 13.56	6.45 Score on a scale Interval 2.14 to 10.77
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 Week 16	18.73 Score on a scale Interval 13.43 to 24.03	15.02 Score on a scale Interval 9.77 to 20.27

SECONDARY outcome

Timeframe: Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SUN13837 n=27 Participants 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).	Placebo n=28 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).
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 Day 3	2.08 Units on a scale Interval -0.14 to 4.31	-1.24 Units on a scale Interval -3.45 to 0.98
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 Week 2	3.98 Units on a scale Interval 1.5 to 6.46	0.59 Units on a scale Interval -1.83 to 3.02
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 Week 4	5.95 Units on a scale Interval 3.4 to 8.5	1.73 Units on a scale Interval -0.79 to 4.24
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 Week 8	8.66 Units on a scale Interval 5.94 to 11.38	3.83 Units on a scale Interval 1.12 to 6.54
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 Week 16	9.92 Units on a scale Interval 7.1 to 12.74	4.95 Units on a scale Interval 2.17 to 7.73

SECONDARY outcome

Timeframe: Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SUN13837 n=27 Participants 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).	Placebo n=28 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).
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 Day 3	2.71 Units on a scale Interval 0.15 to 5.28	3.22 Units on a scale Interval 0.75 to 5.68
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 Week 2	3.66 Units on a scale Interval 0.94 to 6.38	4.28 Units on a scale Interval 1.67 to 6.88
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 Week 4	4.89 Units on a scale Interval 1.82 to 7.96	5.36 Units on a scale Interval 2.41 to 8.31
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 Week 8	5.08 Units on a scale Interval 1.22 to 8.94	8.30 Units on a scale Interval 4.53 to 12.08
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 Week 16	6.13 Units on a scale Interval 1.8 to 10.46	9.96 Units on a scale Interval 5.73 to 14.2

SECONDARY outcome

Timeframe: Baseline up to approximately Day 182 post dose.

Population: The safety population was used to assess adverse events.

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.

Outcome measures

Outcome measures
Measure	SUN13837 n=30 Participants 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).	Placebo n=31 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).
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Anaemia	5 Participants	11 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Respiratory failure	8 Participants	7 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Rash	9 Participants	4 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Blood creatine phosphokinase increased	7 Participants	5 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Urinary tract infection	21 Participants	23 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Pyrexia	17 Participants	14 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Decubitus ulcer	13 Participants	13 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Insomnia	14 Participants	12 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Pneumonia	9 Participants	17 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Nausea	12 Participants	10 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Muscle spasticity	12 Participants	9 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Neuralgia	13 Participants	8 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Anxiety	9 Participants	10 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Constipation	7 Participants	11 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Leukocytosis	8 Participants	10 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Depression	8 Participants	9 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Musculoskeletal pain	10 Participants	7 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Orthostatic hypotension	9 Participants	8 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Muscle spasms	8 Participants	6 Participants
Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury Headache	9 Participants	4 Participants

Adverse Events

SUN13837

Serious events: 21 serious events

Other events: 14 other events

Deaths: 2 deaths

Placebo

Serious events: 23 serious events

Other events: 20 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 908-992-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place