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

NCT01502631 | Completed Phase 2 Results DMC

• 1 other identifier: ASBI 603
• Study Type: interventional
• Target: 65
• Locations: 7 countries
• Sites: 67

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 participants with acute spinal cord injury.

Conditions

Acute Spinal Cord Injury

Keywords

ASCI; SUN13837; Acute traumatic cervical spinal cord injury

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• Sensitivity Analyses of Total Spinal Cord Independence Measure, Version III (SCIM III) Score at Week 16 by Treatment Group

  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

  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

  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

  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

  Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose.

Study Arms (2)

SUN13837

ACTIVE COMPARATOR

Drug: SUN13837 injection

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SUN13837 injection DRUG

SUN13837 injection, injection 1 x daily for 28 doses

SUN13837

Placebo DRUG

Matching placebo, volume equivalent to injection 1 x daily for 28 doses

Placebo

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• Conclusive radiological evidence of complete spinal cord transection
• Multiple injuries to the neurological spinal cord at different levels
• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (67)

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Tucson, Arizona, 85724, United States

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Downey, California, 90242, United States

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Los Angeles, California, 90033, United States

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Sacramento, California, 95817, United States

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San Jose, California, 95128, United States

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Denver, Colorado, 80204, United States

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Englewood, Colorado, 80113, United States

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Newark, Delaware, 19718, United States

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Hollywood, Florida, 33021, United States

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Atlanta, Georgia, 30309, United States

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Atlanta, Georgia, 30322, United States

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Honolulu, Hawaii, 96813, United States

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Indianapolis, Indiana, 67214, United States

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Davenport, Iowa, 52804, United States

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Iowa City, Iowa, 52242, United States

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Kansas City, Kansas, 66160, United States

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Lexington, Kentucky, 40504, United States

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Lexington, Kentucky, 40536, United States

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Columbia, Missouri, 65203, United States

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Columbia, Missouri, 65212, United States

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Kansas City, Missouri, 64108, United States

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Springfield, Missouri, 65807, United States

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Lincoln, Nebraska, 68506, United States

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Omaha, Nebraska, 68122, United States

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Omaha, Nebraska, 68198-2035, United States

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Camden, New Jersey, 08103, United States

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Newark, New Jersey, 07103, United States

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West Orange, New Jersey, 07052, United States

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Great Neck, New York, 11021, United States

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Stony Brook, New York, 11794-8122, United States

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Valhalla, New York, 10595, United States

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White Plains, New York, 10605, United States

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Charlotte, North Carolina, 28203, United States

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Winston-Salem, North Carolina, 27157, United States

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Cleveland, Ohio, 44109, United States

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Dayton, Ohio, 45409, United States

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Malvern, Pennsylvania, 19355, United States

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Philadelphia, Pennsylvania, 19102, United States

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Philadelphia, Pennsylvania, 19140, United States

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Milwaukee, Wisconsin, 53226, United States

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Halifax, Nova Scotia, B3H3A7, Canada

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Hamilton, Ontario, L8L2X2, Canada

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Toronto, Ontario, M4G 3V9, Canada

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Toronto, Ontario, M4G3V9, Canada

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Toronto, Ontario, M5C 1R6, Canada

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Saskatoon, Saskatchewan, S7N 0W8, Canada

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Brno, 625 00, Czechia

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Liberec, 460 63, Czechia

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Ostrava, 708 52, Czechia

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Prague, 150 06, Czechia

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Amiens, 80054, France

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Berck, 62608, France

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Bordeaux, 33076, France

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Bordeaux, 33523, France

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Lille, 59037, France

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Montpellier, 34090, France

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Montpellier, 34295, France

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Lodz, 93-513, Poland

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Sosnowiec, 41-200, Poland

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A Coruña, 15670, Spain

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Barcelona, 08035, Spain

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Barcelona, 08316, Spain

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Barcelona, 08916, Spain

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Seville, 41013, Spain

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Edgbaston, Birmingham, B15 2WB, United Kingdom

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Glasgow, Scotland, G12 0BQ, United Kingdom

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Middlesbrough, TS4 3BW, United Kingdom

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Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2011
• First Posted: January 2, 2012
• Study Start: August 8, 2012
• Primary Completion: September 21, 2014
• Study Completion: September 21, 2014
• Last Updated: January 15, 2021
• Results First Posted: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

CA (6); GB (3); PL (2); FR (7); ES (5); US (40); CZ (4)