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The purpose of this research study is to gather scientific information about the effectiveness of the study drug, SUN13837 Injection, when compared with the placebo (inactive substance) in participants with acute spinal cord injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUN13837 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUN13837 injection | Drug | SUN13837 injection, injection 1 x daily for 28 doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Spinal Cord Independence Measure, Version III (SCIM III) Score Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury | 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. | Week 2, week 4, week 8 and week 16 post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity Analyses of Total Spinal Cord Independence Measure, Version III (SCIM III) Score at Week 16 by Treatment 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: 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. |
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Inclusion Criteria:
Acute traumatic injury to the cervical neurological spinal cord as follows:
Closed single traumatic spinal cord injury occurring within 12 hours of first dosing
Male or female cervical AIS A participants ≥ 16 to ≤ 80 years and male or female cervical AIS B or C participants ≥16 to ≤70 years
Females of childbearing potential and males must agree to maintain adequate contraception for the first 35 days of the study
Exclusion Criteria:
Unable to obtain informed consent (either from the participant or from the participant's legally authorized representative [LAR])
Women who are breastfeeding (if unwilling to stop for the first 35 days of the study) or who are pregnant
Coma or significant impairment in the level of consciousness that interferes with the performance or interpretation of protocol specified assessments
Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol specified assessments
Unable, as determined by the investigator, or unwilling to discontinue use of potent P-glycoprotein (P-gp) inhibitors for the first 35 days of the study
Unable, as determined by the investigator, or unwilling to discontinue use of potent cytochrome P450 (CYP) 3A4/5 inducers for the first 35 days of the study
Renal compromise (serum creatinine greater than 1.5 times the age- and sex-appropriate upper limit of normal [ULN]) at screening before the first dose of study drug
Severe Hepatic dysfunction (serum alanine transaminase [ALT], aspartate transaminase [AST], and/or gamma-glutamyltransferase [GGT] ALL greater than 2.5 times the age- and sex-appropriate ULN) or hepatic impairment (detectable ascites, serum bilirubin greater than 2 mg/dL, serum albumin less than 3.5 g/dL, and prothrombin time prolonged by more than 6 seconds above the ULN for the local laboratory in the absence of anticoagulant therapy) at screening before the first dose of study drug
Concomitant spinal cord injury or abnormality as determined by routine imaging:
History of symptomatic cervical spinal stenosis with myelopathy as a factor confounding participant assessment
Unlikely to be available for follow-up as specified in the protocol
Participated in a previous clinical study and received an investigational product within 30 days of screening
Previous exposure to SUN13837
Allergy to SUN13837 or any of its excipients
Any other issue which, in the opinion of the investigator, made the participant unsuitable for study participation.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85724 | United States | |||
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Participants with acute traumatic cervical spinal cord injury (ASCI) within 12 hours of treatment were enrolled in this study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
Matching placebo, volume equivalent to injection 1 x daily for 28 doses |
|
| Week 16 post dose |
| 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 | 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). | Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose. |
| 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 | 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 | Week 2, Week 4, Week 8, and Week 16 post dose. |
| 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 | 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. | Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose. |
| 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 | 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. | Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose. |
| Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury | 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. | Baseline up to approximately Day 182 post dose. |
| Downey |
| California |
| 90242 |
| United States |
| Los Angeles | California | 90033 | United States |
| Sacramento | California | 95817 | United States |
| San Jose | California | 95128 | United States |
| Denver | Colorado | 80204 | United States |
| Englewood | Colorado | 80113 | United States |
| Newark | Delaware | 19718 | United States |
| Hollywood | Florida | 33021 | United States |
| Atlanta | Georgia | 30309 | United States |
| Atlanta | Georgia | 30322 | United States |
| Honolulu | Hawaii | 96813 | United States |
| Indianapolis | Indiana | 67214 | United States |
| Davenport | Iowa | 52804 | United States |
| Iowa City | Iowa | 52242 | United States |
| Kansas City | Kansas | 66160 | United States |
| Lexington | Kentucky | 40504 | United States |
| Lexington | Kentucky | 40536 | United States |
| Columbia | Missouri | 65203 | United States |
| Columbia | Missouri | 65212 | United States |
| Kansas City | Missouri | 64108 | United States |
| Springfield | Missouri | 65807 | United States |
| Lincoln | Nebraska | 68506 | United States |
| Omaha | Nebraska | 68122 | United States |
| Omaha | Nebraska | 68198-2035 | United States |
| Camden | New Jersey | 08103 | United States |
| Newark | New Jersey | 07103 | United States |
| West Orange | New Jersey | 07052 | United States |
| Great Neck | New York | 11021 | United States |
| Stony Brook | New York | 11794-8122 | United States |
| Valhalla | New York | 10595 | United States |
| White Plains | New York | 10605 | United States |
| Charlotte | North Carolina | 28203 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Cleveland | Ohio | 44109 | United States |
| Dayton | Ohio | 45409 | United States |
| Malvern | Pennsylvania | 19355 | United States |
| Philadelphia | Pennsylvania | 19102 | United States |
| Philadelphia | Pennsylvania | 19140 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| Halifax | Nova Scotia | B3H3A7 | Canada |
| Hamilton | Ontario | L8L2X2 | Canada |
| Toronto | Ontario | M4G 3V9 | Canada |
| Toronto | Ontario | M4G3V9 | Canada |
| Toronto | Ontario | M5C 1R6 | Canada |
| Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Brno | 625 00 | Czechia |
| Liberec | 460 63 | Czechia |
| Ostrava | 708 52 | Czechia |
| Prague | 150 06 | Czechia |
| Amiens | 80054 | France |
| Berck | 62608 | France |
| Bordeaux | 33076 | France |
| Bordeaux | 33523 | France |
| Lille | 59037 | France |
| Montpellier | 34090 | France |
| Montpellier | 34295 | France |
| Lodz | 93-513 | Poland |
| Sosnowiec | 41-200 | Poland |
| A Coruña | 15670 | Spain |
| Barcelona | 08035 | Spain |
| Barcelona | 08316 | Spain |
| Barcelona | 08916 | Spain |
| Seville | 41013 | Spain |
| Edgbaston | Birmingham | B15 2WB | United Kingdom |
| Glasgow | Scotland | G12 0BQ | United Kingdom |
| Middlesbrough | TS4 3BW | United Kingdom |
| 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). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline characteristics were assessed in the Safety Population.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Spinal Cord Independence Measure, Version III (SCIM III) Score Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury | 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | Score on a scale | Week 2, week 4, week 8 and week 16 post dose. |
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| Secondary | Sensitivity Analyses of Total Spinal Cord Independence Measure, Version III (SCIM III) Score at Week 16 by Treatment 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: 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | Score on a scale | Week 16 post dose |
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| Secondary | 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 | 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). | 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. | Posted | Least Squares Mean | 90% Confidence Interval | Units on a scale | Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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 | 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. | Posted | Least Squares Mean | 90% Confidence Interval | Score on a scale | Week 2, Week 4, Week 8, and Week 16 post dose. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | Units on a scale | Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | 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. | Posted | Least Squares Mean | 90% Confidence Interval | Units on a scale | Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury | 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. | The safety population was used to assess adverse events. | Posted | Count of Participants | Participants | Baseline up to approximately Day 182 post dose. |
|
Baseline up to approximately Day 182 post dose.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 2 | 30 | 21 | 30 | 14 | 30 |
| EG001 | 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). | 2 | 31 | 23 | 31 | 20 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Euthanasia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Lung infection pseudomonal | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Urinary tract infection fungal | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pyuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Urine abnormality | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Withdrawal of life support | Surgical and medical procedures | MedDRA (15.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Muscle spasticity | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Neurogenic bladder | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Neurogenic bowel | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Pseudomeningocele | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Euthanasia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Autonomic dysreflexia | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Alanin aminotransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increase | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Extremity contracture | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Spinal cord oedema | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Osteosynthesis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Withdrawal of life support | Surgical and medical procedures | MedDRA (15.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo | 908-992-6400 | CTRinfo@dsi.com |
| ≥ 55 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Week 8 |
|
| Week 16 |
|
| Mixed Model Repeated Measures (MMRM) |
| 0.2260 |
| Least Squares (LS) Mean |
| 6.87 |
| Standard Error of the Mean |
| 5.583 |
| 2-Sided |
| 90 |
| -2.54 |
| 16.27 |
| Superiority |
| Difference (SUN13837 - Placebo) at Week 8 | Mixed Model Repeated Measures (MMRM) | 0.6184 | Least Squares (LS) Mean | 3.03 | Standard Error of the Mean | 6.023 | 2-Sided | 90 | -7.15 | 13.21 | Superiority |
| Difference (SUN13837 - Placebo) at Week 16 | Mixed Model Repeated Measures (MMRM) | 0.4912 | Least Squares (LS) Mean | 4.54 | Standard Error of the Mean | 6.524 | 2-Sided | 90 | -6.48 | 15.56 | Superiority |
| 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). |
|
|
| OG001 | 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). |
|
|
| 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). |
|
|
|
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| Counts |
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| Participants |
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