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

• ClinicalTrials.gov Identifier: NCT01502631
• Recruitment Status: Completed
• First Posted: January 2, 2012
• Last Update Posted: August 25, 2016
• Sponsor: Daiichi Sankyo, Inc.
• Information provided by (Responsible Party): Daiichi Sankyo, Inc.

Tracking Information

• First Submitted Date: December 27, 2011
• First Posted Date: January 2, 2012
• Last Update Posted Date: August 25, 2016
• Study Start Date: January 2012
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 29, 2011): Comparison of the proportion of SUN13837 treated subjects and placebo-treated subjects who are defined as responders. [ Time Frame: Day 112 (±7 days) ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: December 29, 2011): Comparison of means in the SCIM III self-care subscale score in responders [ Time Frame: Day 112 (±7 days) ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury (ASCI)
• Official Title: 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
• Brief 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 subjects with acute spinal cord injury.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acute Spinal Cord Injury

Intervention

• Drug: SUN13837 injection
  SUN13837 injection, injection 1 x daily for 28 doses
• Drug: Placebo
  Matching placebo, volume equivalent to injection 1 x daily for 28 doses

Study Arms

• Active Comparator: SUN13837
  Intervention: Drug: SUN13837 injection
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 1, 2015): 62
• Original Estimated Enrollment (submitted: December 29, 2011): 164
• Actual Study Completion Date: March 2015
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Acute traumatic injury to the cervical neurological spinal cord as follows:

   1. American Spinal Injury Association Impairment Scale A with a level of injury at either C4, C5, C6, or C7 (for C4, the subject must have at least 1 point of motor activity within the ZPP inclusive of C5 to T1). In addition, the AIS A subject 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 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 AIS A subjects ≥ 16 to ≤ 80 years and male or female cervical AIS B or C subjects ≥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 subject or from the subject's 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
   2. Multiple injuries to the neurological spinal cord at different levels
10. History of symptomatic cervical spinal stenosis with myelopathy as a factor confounding subject assessment
11. Unlikely to be available for follow-up as specified in the protocol
12. Participated in a previous clinical study and received an investigational product within 30 days of screening
13. Previous exposure to SUN13837
14. Allergy to SUN13837 or any of its excipients

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 80 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, Czech Republic, France, Poland, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT01502631
• Other Study ID Numbers: ASBI 603
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Daiichi Sankyo, Inc.
• Study Sponsor: Daiichi Sankyo, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Daiichi Sankyo, Inc.
• Verification Date: August 2016