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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Asubio Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01502631
First received: December 27, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Acute Spinal Cord Injury
Drug: SUN13837 injection
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Asubio Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Comparison of the proportion of SUN13837 treated subjects and placebo-treated subjects who are defined as responders. [ Time Frame: Day 112 (±7 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of means in the SCIM III self-care subscale score in responders [ Time Frame: Day 112 (±7 days) ] [ Designated as safety issue: No ]

Estimated Enrollment: 164
Study Start Date: January 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SUN13837 Drug: SUN13837 injection
SUN13837 injection, injection 1 x daily for 28 doses
Placebo Comparator: Placebo Drug: Placebo
Matching placebo, volume equivalent to injection 1 x daily for 28 doses

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502631

Contacts
Contact: Mary Brantner, MS (201) 368-5054 mbrantner@asubio.com

  Show 70 Study Locations
Sponsors and Collaborators
Asubio Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01502631     History of Changes
Other Study ID Numbers: ASBI 603
Study First Received: December 27, 2011
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 24, 2014