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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01502631
Recruitment Status : Completed
First Posted : January 2, 2012
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE December 27, 2011
First Posted Date  ICMJE January 2, 2012
Last Update Posted Date August 25, 2016
Study Start Date  ICMJE January 2012
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury (ASCI)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Spinal Cord Injury
Intervention  ICMJE
  • 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  ICMJE
  • Active Comparator: SUN13837
    Intervention: Drug: SUN13837 injection
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2015)
62
Original Estimated Enrollment  ICMJE
 (submitted: December 29, 2011)
164
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czech Republic,   France,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01502631
Other Study ID Numbers  ICMJE ASBI 603
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daiichi Sankyo, Inc.
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP