AzTrials
AzTrials

Acute Spinal Cord InjuryPhase 2NCT01502631

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

A Phase 2 study testing SUN13837 injection in people with Acute Spinal Cord Injury, run by Daiichi Sankyo at 67 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Acute Spinal Cord Injury
What is being tested?
SUN13837 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
67 sitesin 7 countries
Study dates
8 Aug 2012to 21 Sep 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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
  • Allergy to SUN13837 or any of its excipients
  • Any other issue which, in the opinion of the investigator, made the participant unsuitable for study participation.

Trial locations and contacts

67 sites in 7 countries.

67 sites in 7 countries

United States40 sites

  • Study site

    Atlanta, Georgia, 30309

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Camden, New Jersey, 08103

  • Study site

    Charlotte, North Carolina, 28203

  • Study site

    Cleveland, Ohio, 44109

  • Study site

    Columbia, Missouri, 65203

  • Study site

    Columbia, Missouri, 65212

  • Study site

    Davenport, Iowa, 52804

  • Study site

    Dayton, Ohio, 45409

  • Study site

    Denver, Colorado, 80204

  • Study site

    Downey, California, 90242

  • Study site

    Englewood, Colorado, 80113

  • Study site

    Great Neck, New York, 11021

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Honolulu, Hawaii, 96813

  • Study site

    Indianapolis, Indiana, 67214

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Kansas City, Missouri, 64108

  • Study site

    Lexington, Kentucky, 40504

  • Study site

    Lexington, Kentucky, 40536

  • Study site

    Lincoln, Nebraska, 68506

  • Study site

    Los Angeles, California, 90033

  • Study site

    Malvern, Pennsylvania, 19355

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Newark, Delaware, 19718

  • Study site

    Newark, New Jersey, 07103

  • Study site

    Omaha, Nebraska, 68122

  • Study site

    Omaha, Nebraska, 68198-2035

  • Study site

    Philadelphia, Pennsylvania, 19102

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Study site

    Sacramento, California, 95817

  • Study site

    San Jose, California, 95128

  • Study site

    Springfield, Missouri, 65807

  • Study site

    Stony Brook, New York, 11794-8122

  • Study site

    Tucson, Arizona, 85724

  • Study site

    Valhalla, New York, 10595

  • Study site

    West Orange, New Jersey, 07052

  • Study site

    White Plains, New York, 10605

  • Study site

    Winston-Salem, North Carolina, 27157

Other trials in United States

France7 sites

  • Study site

    Amiens, 80054

  • Study site

    Berck, 62608

  • Study site

    Bordeaux, 33076

  • Study site

    Bordeaux, 33523

  • Study site

    Lille, 59037

  • Study site

    Montpellier, 34090

  • Study site

    Montpellier, 34295

Other trials in France

Canada6 sites

  • Study site

    Halifax, Nova Scotia, B3H3A7

  • Study site

    Hamilton, Ontario, L8L2X2

  • Study site

    Saskatoon, Saskatchewan, S7N 0W8

  • Study site

    Toronto, Ontario, M4G 3V9

  • Study site

    Toronto, Ontario, M4G3V9

  • Study site

    Toronto, Ontario, M5C 1R6

Other trials in Canada

Spain5 sites

  • Study site

    A Coruña, 15670

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08316

  • Study site

    Barcelona, 08916

  • Study site

    Seville, 41013

Other trials in Spain

Czechia4 sites

  • Study site

    Brno, 625 00

  • Study site

    Liberec, 460 63

  • Study site

    Ostrava, 708 52

  • Study site

    Prague, 150 06

Other trials in Czechia

United Kingdom3 sites

  • Study site

    Edgbaston, Birmingham, B15 2WB

  • Study site

    Glasgow, Scotland, G12 0BQ

  • Study site

    Middlesbrough, TS4 3BW

Other trials in United Kingdom

Poland2 sites

  • Study site

    Lodz, 93-513

  • Study site

    Sosnowiec, 41-200

Other trials in Poland

About this study

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

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.

Being tested
SUN13837 injection, Placebo
Keywords
ASCI, SUN13837, Acute traumatic cervical spinal cord injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SUN13837 injectionDrug

    SUN13837 injection, injection 1 x daily for 28 doses

  • PlaceboDrug

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

Study groups in NCT01502631
Study groupRoleWhat they receive
SUN13837Active comparatorNot described
Receives: Drug: SUN13837 injection
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 2, week 4, week 8 and week 16 post dose.

Secondary outcomes (6)

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

    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.

    Measured: Week 16 post dose

  2. 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

    TMS was the sum of the overall Upper Extremity Motor Score (UEMS) and the overall Lower Extremity Motor Score (LEMS) of ISNCSCI. The score on the scale runs from a minimum value of 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. The UEMS was defined as the sum of the motor function scores in the cervical spinal segments C5, C6, C7, C8, and T1. A separate sum was obtained for the right and left sides (a maximum of 25 points each) and for an overall score (with a maximum score of 50). The LEMS was defined as the sum of the motor function scores in the spinal segments lumbar level 2, lumbar level 3, lumbar level 4, lumbar level 5, and sacral level 1. A separate sum was obtained for the right and left sides (a maximum of 25 points each) and for an overall score (with a maximum score of 50).

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

  3. 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

    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, two of which are Self-care and Mobility. The self-care domain is a subscale of 6 items and scores range from 0 to 20 (higher scores indicate a better outcome). The mobility domain consists of 9 items with subscale scores range from 0 to 40 (higher scores indicate a better outcome). The score for the combined Self-Care and Mobility subscale ranges from 0 - 60 points; higher scores indicate a better outcome

    Measured: Week 2, Week 4, Week 8, and Week 16 post dose.

  4. 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

    The UEMS was defined as the sum of the motor function scores in the cervical spinal segments C5, C6, C7, C8, and T1. A separate sum was obtained for the right and left sides (a maximum of 25 points each) and an overall score of 0-50 with a maximum score of 50. A higher score indicates a better outcome.

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

  5. 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

    The LEMS was defined as the sum of the motor function scores in the spinal segments lumbar level 2, lumbar level 3, lumbar level 4, lumbar level 5, and sacral level 1. A separate sum was obtained for the right and left sides (a maximum of 25 points each) and for an overall score with a maximum score of 50. A higher score indicates a better outcome.

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

  6. Incidence of Adverse Events Reported in ≥ 20% of Participants Following Treatment With SUN13837 Injection or Placebo in Adult With Acute Spinal Cord Injury

    The protocol defined an adverse event (AE) as any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

    Measured: Baseline up to approximately Day 182 post dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2012 (estimated)
  2. Study start8 Aug 2012
  3. Primary completion21 Sep 2014
  4. Study completion21 Sep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01502631
Sponsor's protocol ID
ASBI 603
Status last verified
Jan 2021
First submitted
27 Dec 2011
Last updated
15 Jan 2021
Data monitoring committee
Yes
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SUN13837 injection in people with Acute Spinal Cord Injury, run by Daiichi Sankyo at 67 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, France, Canada, Spain, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Week 2, week 4, week 8 and week 16 post dose.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01502631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in