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NCT01502631 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury (ASCI)
A Phase 2 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT01502631: Completed Phase 2 study, sponsored by Daiichi Sankyo.
NCT01502631 is a Phase 2 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01502631, a Phase 2 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG SUN13837 injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2012-08-08 |
| Est. Completion | 2014-09-21 |
| Phase | Phase 2 |
What the finished NCT01502631 record still lists
NCT01502631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01502631 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01502631 about?
NCT01502631 is a clinical study titled "Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury (ASCI)". 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.
What is the current status of trial NCT01502631?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2012-08-08. Estimated completion is 2014-09-21.
What interventions are being tested in trial NCT01502631?
The interventions under investigation include: Placebo (DRUG), SUN13837 injection (DRUG).
Who is sponsoring clinical trial NCT01502631?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01502631's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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