Spinal Cord InjuriesPhase 3NCT03229031
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury
A Phase 3 study testing ES135 in people with Spinal Cord Injuries, run by Eusol Biotech Co., Ltd. at 3 sites in Taiwan.
Trial summary
To demonstrate the superior effect of ES135 combined with spinal cord repairing surgery, compared to a placebo control with spinal cord repairing surgery, on post-surgery motor function recovery as measured by the changes from baseline of ISNCSCI Motor Scores in subjects Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- ES135
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 3 sitesTaiwan
- Study dates
- 7 Mar 2018to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects of either sex and 15-65 years of age.
- Subjects have spinal cord injury and the subjects must be categorized as Grade A or B by the ASIA Impairment Scale.
- Subjects have adequate heart, lung, kidney and liver function.
- Subjects are able to give voluntary and dated informed consent prior to enrollment.
Who cannot join
- Penetration SCI
- Brain damage or multiple injuries
- History of congenital or acquired abnormalities in the spinal cavity
- History of congenital or acquired immunodeficiency disorders
- History of malignancies or positive results
- Current serious/uncontrollable infections or others serious diseases
Show all 9Show fewer
- Pregnant or lactating women
- Allergy to ES135 or any of its excipients
- Unable to obtain informed consent from subject
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Kaohsiung Veterans General Hospital
Kaohsiung City
Far Eastern Memorial Hospital
New Taipei City
Taipei Veterans General Hospital
Taipei
About this study
To demonstrate the superior effect of ES135 combined with spinal cord repairing surgery, compared to a placebo control with spinal cord repairing surgery, on post-surgery motor function recovery as measured by the changes from baseline of ISNCSCI Motor Scores in subjects
- Conditions
- Spinal Cord Injuries
- Being tested
- ES135
- Keywords
- spinal cord, spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ES135Drug
ES135 will be administered via intrathecal
| Study group | Role | What they receive |
|---|---|---|
| ES135 | Experimental | Not described Receives: Drug: ES135 |
| Placebo | Placebo comparator | Not described Receives: Drug: ES135 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start7 Mar 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eusol Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229031
- Sponsor's protocol ID
- ES135-1601
- Status last verified
- May 2024
- First submitted
- 20 Jul 2017
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03229031
- Acronym / sponsor ID
- ES135-1601
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord, spinal cord injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: low recruitment rate
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Eusol Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the superior effect of ES135 combined with spinal cord repairing surgery, compared to a placebo control with spinal cord repairing surgery, on post-surgery motor function recovery as measured by the changes from baseline of ISNCSCI Motor Scores in subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ES135 | Experimental | Drug: ES135 |
| Placebo | Placebo comparator | Drug: ES135 |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects of either sex and 15-65 years of age.
- Subjects have spinal cord injury and the subjects must be categorized as Grade A or B by the ASIA Impairment Scale.
- Subjects have adequate heart, lung, kidney and liver function.
- Subjects are able to give voluntary and dated informed consent prior to enrollment.
Key exclusion criteria (9 listed)
- Penetration SCI
- Brain damage or multiple injuries
- History of congenital or acquired abnormalities in the spinal cavity
- History of congenital or acquired immunodeficiency disorders
- History of malignancies or positive results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ES135ES135 will be administered via intrathecal | Drug | ES135, Placebo |
Primary outcome
Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ES135 in people with Spinal Cord Injuries, run by Eusol Biotech Co., Ltd. at 3 sites in Taiwan.
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 4 inclusion and 9 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: paused, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024; AzTrials last refreshed its copy on 30 Oct 2026.