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

COMPLETEDPHASE2

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury

NCT01502631•Daiichi Sankyo

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

16 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Acute traumatic injury to the cervical neurological spinal cord as follows:
•1. American Spinal Injury Association Impairment Scale A (AIS A) with a level of injury at either cervical level C4, C5, C6, C7 (for C4, the participant must have at least 1 point of motor activity within the zone of partial preservation (ZPP) inclusive of C5 to thoracic level 1 \[T1\]). In addition, the AIS A participant may be included if ALL of the following are present 1) the most caudal intact sensory segment (both pinprick and light touch) is C3, 2) at least one side (right or left) has both intact pinprick and light touch sensation in the C4 dermatome, AND 3) at least 1 point of motor activity within the ZPP inclusive of C5 to T1
•2. American Spinal Injury Association Impairment Scale B or C (AIS B or C) with a neurological level of injury at either C3, C4, C5, C6, C7, or C8 AND a total LEMS of 5 or fewer motor points
•2. Closed single traumatic spinal cord injury occurring within 12 hours of first dosing
•3. 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
•4. Females of childbearing potential and males must agree to maintain adequate contraception for the first 35 days of the study

Exclusion Criteria

•1. Unable to obtain informed consent (either from the participant or from the participant's legally authorized representative \[LAR\])
•2. Women who are breastfeeding (if unwilling to stop for the first 35 days of the study) or who are pregnant
•3. Coma or significant impairment in the level of consciousness that interferes with the performance or interpretation of protocol specified assessments
•4. Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol specified assessments
•5. 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
•6. 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
•7. 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
•8. 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
•9. Concomitant spinal cord injury or abnormality as determined by routine imaging:
•1. Conclusive radiological evidence of complete spinal cord transection
+7 more criteria

Locations (67)

Tucson, Arizona, United States

Downey, California, United States

Los Angeles, California, United States

Sacramento, California, United States

San Jose, California, United States

Denver, Colorado, United States

Englewood, Colorado, United States

Newark, Delaware, United States

Hollywood, Florida, United States

Atlanta, Georgia, United States

Key Dates

Start Date

August 8, 2012

Primary Completion Date

September 21, 2014

Completion Date

September 21, 2014

Last Updated

January 15, 2021

Enrollment

ACTUAL participants

Conditions

Acute Spinal Cord Injury

Interventions

SUN13837 injection

DRUG

Placebo

DRUG

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NCT06654804

Acute Spinal Cord Injury

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COMPLETEDPHASE1

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Acute Spinal Cord Injury

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Contrast-enhanced Ultrasound in the Treatment of Acute Spinal Cord Injury

Study to Evaluate the Safety and Pharmacokinetics of ALMB-0166 in Patients With Acute Spinal Cord Injury

Stem Cells in Spinal Cord Injury

Spasticity and Functional Recovery After SCI

Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study

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