Clinical trial NCT01502631: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Spinal Cord Injury
Keywords: ASCI
SUN13837
Acute traumatic cervical spinal cord injury
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2012-01-02
Enrollment: 65
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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
   2. Multiple injuries to the neurological spinal cord at different levels
10. History of symptomatic cervical spinal stenosis with myelopathy as a factor confounding participant 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
15. Any other issue which, in the opinion of the investigator, made the participant unsuitable for study participation.

Primary outcomes:
measure: Total Spinal Cord Independence Measure, Version III (SCIM III) Score Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury
timeFrame: Week 2, week 4, week 8 and week 16 post dose.
Secondary outcomes:
measure: Sensitivity Analyses of Total Spinal Cord Independence Measure, Version III (SCIM III) Score at Week 16 by Treatment Group
timeFrame: Week 16 post dose
measure: 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
timeFrame: Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose.
measure: 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
timeFrame: Week 2, Week 4, Week 8, and Week 16 post dose.
measure: 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
timeFrame: Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose.
measure: 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
timeFrame: Baseline to Day 3, Week 2, Week 4, Week 8, and Week 16 post dose.
measure: Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury
timeFrame: Baseline up to approximately Day 182 post dose.
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Downey
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Jose
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Newark
country: United States
state: Delaware
city: Hollywood
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Indianapolis
country: United States
state: Indiana
city: Davenport
country: United States
state: Iowa
city: Iowa City
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Columbia
country: United States
state: Missouri
city: Columbia
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Camden
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: West Orange
country: United States
state: New Jersey
city: Great Neck
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Valhalla
country: United States
state: New York
city: White Plains
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Malvern
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Milwaukee
country: United States
state: Wisconsin
city: Halifax
country: Canada
state: Nova Scotia
city: Hamilton
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Saskatoon
country: Canada
state: Saskatchewan
city: Brno
country: Czechia
city: Liberec 1
country: Czechia
city: Ostrava
country: Czechia
city: Prague 5
country: Czechia
city: Amiens Cedex
country: France
city: Berck
country: France
city: Bordeaux
country: France
city: Bordeaux
country: France
city: Lille Cedex
country: France
city: Montpellier
country: France
city: Montpellier
country: France
city: Lodz
country: Poland
city: Sosnowiec
country: Poland
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: La Coruña
country: Spain
city: Sevilla
country: Spain
city: Edgbaston
country: United Kingdom
state: Birmingham
city: Glasgow
country: United Kingdom
state: Scotland
city: Middlesborough
country: United Kingdom
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: