Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury (ASCI)
NCT ID: NCT01502631
Last Updated: 2021-01-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2012-08-08
2014-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SUN13837
SUN13837 injection
SUN13837 injection, injection 1 x daily for 28 doses
Placebo
Placebo
Matching placebo, volume equivalent to injection 1 x daily for 28 doses
Interventions
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SUN13837 injection
SUN13837 injection, injection 1 x daily for 28 doses
Placebo
Matching placebo, volume equivalent to injection 1 x daily for 28 doses
Eligibility Criteria
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Inclusion Criteria
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
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.
16 Years
80 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Tucson, Arizona, United States
Downey, California, United States
Los Angeles, California, United States
Sacramento, California, United States
San Jose, California, United States
Denver, Colorado, United States
Englewood, Colorado, United States
Newark, Delaware, United States
Hollywood, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Indianapolis, Indiana, United States
Davenport, Iowa, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Columbia, Missouri, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
Springfield, Missouri, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Camden, New Jersey, United States
Newark, New Jersey, United States
West Orange, New Jersey, United States
Great Neck, New York, United States
Stony Brook, New York, United States
Valhalla, New York, United States
White Plains, New York, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Malvern, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Milwaukee, Wisconsin, United States
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Saskatoon, Saskatchewan, Canada
Brno, , Czechia
Liberec, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Amiens, , France
Berck, , France
Bordeaux, , France
Bordeaux, , France
Lille, , France
Montpellier, , France
Montpellier, , France
Lodz, , Poland
Sosnowiec, , Poland
A Coruña, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Seville, , Spain
Edgbaston, Birmingham, United Kingdom
Glasgow, Scotland, United Kingdom
Middlesbrough, , United Kingdom
Countries
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Other Identifiers
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ASBI 603
Identifier Type: -
Identifier Source: org_study_id
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