Acute Cervical Spinal Cord InjuryPhase 2NCT00610337
Safety and Efficacy of Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury
A Phase 2 study testing Cethrin® (BA-210) in people with Acute Cervical Spinal Cord Injury, run by BioAxone BioSciences, Inc..
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to be conducted in North America and Europe and will include male and female subjects with acute cervical SCI, 18 to 62 years of age, who receive clinical trial material (CTM) within 72 hours of injury. Read more about this study
- Who is it for?
- Ages 18 to 62 years
- Conditions the study is for
- Acute Cervical Spinal Cord Injury
- What is being tested?
- Cethrin® (BA-210)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 18 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to understand the requirements of the study, provide informed consent, agree to the study restrictions, and agree to return for the required assessments
- Males or females, 18 through 62 years of age, inclusive
- AIS Grade A, complete injury with the ability to obtain accurate baseline assessment
- Motor neurological level of C5, C6, or C7
- Subjects with acute cervical SCI scheduled to receive decompression/stabilization surgery
- Must be willing and able to participate in study procedures and assessments
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- Must be medically stable
- If of childbearing potential, women must agree to either of the following for the duration of the 12-month trial: (a) abstinence, or (b) if sexually active, to use one of the following methods of birth control: barrier with spermicide, intrauterine device, birth control hormones, or surgical sterilization
- Must provide witnessed verbal authorization for use and disclosure of protected health information (PHI)
Who cannot join
- Subjects who have participated in a clinical trial involving investigational medications, devices or procedures within 30 days before administration of CTM
- Subjects who require the use of mechanical ventilation
- Females with a positive serum pregnancy test
- Females who are breastfeeding
- Preexisting SCI
- Subjects who are unable to receive study medication within 72 hours of injury
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- Subjects with peripheral nerve injury, brachial plexus injury, or multifocal SCI
- Subjects with injuries that prevent a comprehensive ASIA assessment
- Complete spinal cord transection
- Acute SCI because of gun shot or knife wound
- Subjects who are mentally or medically unstable, or are otherwise unlikely to complete the trial in the judgment of the investigator
- Subjects who present with history of symptomatic cervical spondylotic myelopathy
- Subjects with moderate to severe traumatic brain injury with a Glasgow Coma Scale score of less than 14
- History of multiple sclerosis or other neuromuscular disorder
- History of an adverse reaction to a fibrin sealant or its human or bovine components
- Clinically significant neurological, cardiac, respiratory, hepatic, or renal disease
- History of cancer (except for basal cell carcinoma)
- Hemophilia or other bleeding abnormality
- Ankylosing spondylitis
- Use of insulin therapy to control diabetes mellitus within 6 months of SCI
- Known immunodeficiency, including human immunodeficiency virus or use of immunosuppressive or cancer chemotherapeutic drugs
- Body mass index (BMI) of ≥40 kg/m2 at screening (Appendix B includes a table for height and weight to calculate BMI)
About this study
Official title: A Phase IIb, Double-Blind, Randomized, Placebo Controlled, Multicenter Study to Assess the Safety and Efficacy of Intraoperative Epidural Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury
This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to be conducted in North America and Europe and will include male and female subjects with acute cervical SCI, 18 to 62 years of age, who receive clinical trial material (CTM) within 72 hours of injury.
This study is being undertaken to evaluate and confirm the safety and efficacy of CETHRIN®. This adaptive study has been designed to efficiently identify the safest and most effective dose in Phase IIb which will be evaluated in a future Phase III study. Given the current lack of effective treatments for SCI, an improvement in motor ability or activities of daily living in these subjects would be a great advancement in the treatment of SCI.
- Conditions
- Acute Cervical Spinal Cord Injury
- Being tested
- Cethrin® (BA-210), placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cethrin® (BA-210)Drug
Also called Cethrin®
Intraoperative epidural administration during spinal decompression surgery
placeboProcedure or surgery
Spinal decompression surgery without administration of Cethrin® BA-210
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Procedure: placebo |
| 2 | Experimental | 1mg Cethrin® Receives: Drug: Cethrin® (BA-210) |
| 3 | Experimental | 3mg Cethrin® Receives: Drug: Cethrin® (BA-210) |
| 4 | Experimental | 6mg Cethrin® Receives: Drug: Cethrin® (BA-210) |
| 5 | Experimental | 12mg Cethrin®. Administration of this dose is dependent on data from lower doses. Receives: Drug: Cethrin® (BA-210) |
| 6 | Experimental | 18mg Cethrin®. Administration of this dose is dependent on data from lower doses. Receives: Drug: Cethrin® (BA-210) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in ASIA motor score
Measured: week 26
Death
Measured: 12 months
Serious Adverse Events
Measured: 12 months
Secondary outcomes (7)
ASIA Impairment Scale (AIS) grade
Measured: Week 4, Week 8, Week 16, Week 26, and Week 52
Total motor score, upper extremity motor score, and lower extremity motor score
Measured: Week 4, Week 8, Week 16, Week 26, and Week 52
Neurological motor level (right and left) and motor zone of partial preservation (ZPP) (right and left)
Measured: Week 4, Week 8, Week 16, Week 26, and Week 52
Change in motor score within the ZPP (right and left)
Measured: Week 4, Week 8, Week 16, Week 26, and Week 52
Spinal cord independence measure (SCIM) total score, subscores and individual items
Measured: Week 4, Week 8, Week 16, Week 26, and Week 52
Functional independence measure (FIM) total score, subscores and individual items
Measured: Week 4, Week 8, Week 16, Week 26, and Week 52
Adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
Why it stopped: Due to a change of sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Cervical Spinal Cord InjuryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioAxone BioSciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610337
- Sponsor's protocol ID
- ALSE-C-01
- Status last verified
- Feb 2010
- First submitted
- 15 Jan 2008
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Double-Blind, Randomized, Placebo Controlled, Multicenter Study to Assess the Safety and Efficacy of Intraoperative Epidural Cethrin® in Adult Subjects With Acute Cervical Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00610337
- Acronym / sponsor ID
- ALSE-C-01
- Conditions
- Acute Cervical Spinal Cord Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to a change of sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioAxone BioSciences, Inc.Industry (pharma, biotech, devices)
- First posted
- 7 Feb 2008 (estimated)
- 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.
This is a multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to be conducted in North America and Europe and will include male and female subjects with acute cervical SCI, 18 to 62 years of age, who receive clinical trial material (CTM) within 72 hours of injury.
This study is being undertaken to evaluate and confirm the safety and efficacy of CETHRIN®. This adaptive study has been designed to efficiently identify the safest and most effective dose in Phase IIb which will be evaluated in a future Phase III study. Given the current lack of effective treatments for SCI, an improvement in motor ability or activities of daily living in these subjects would be a great advancement in the treatment of SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Procedure: placebo |
| 2 | Experimental | Drug: Cethrin® (BA-210)1mg Cethrin® |
| 3 | Experimental | Drug: Cethrin® (BA-210)3mg Cethrin® |
| 4 | Experimental | Drug: Cethrin® (BA-210)6mg Cethrin® |
| 5 | Experimental | Drug: Cethrin® (BA-210)12mg Cethrin®. Administration of this dose is dependent on data from lower doses. |
| 6 | Experimental | Drug: Cethrin® (BA-210)18mg Cethrin®. Administration of this dose is dependent on data from lower doses. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Ability to understand the requirements of the study, provide informed consent, agree to the study restrictions, and agree to return for the required assessments
- Males or females, 18 through 62 years of age, inclusive
- AIS Grade A, complete injury with the ability to obtain accurate baseline assessment
- Motor neurological level of C5, C6, or C7
- Subjects with acute cervical SCI scheduled to receive decompression/stabilization surgery
Key exclusion criteria (22 listed)
- Subjects who have participated in a clinical trial involving investigational medications, devices or procedures within 30 days before administration of CTM
- Subjects who require the use of mechanical ventilation
- Females with a positive serum pregnancy test
- Females who are breastfeeding
- Preexisting SCI
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 |
|---|---|---|
| Cethrin® (BA-210)Also: Cethrin®Intraoperative epidural administration during spinal decompression surgery | Drug | 2, 3, 4, 5, 6 |
| placeboSpinal decompression surgery without administration of Cethrin® BA-210 | Procedure or surgery | 1 |
Primary outcome
Mean change in ASIA motor score
Time frame: week 26
Death
Time frame: 12 months
Serious Adverse Events
Time frame: 12 months
7 secondary outcomes
ASIA Impairment Scale (AIS) grade
Time frame: Week 4, Week 8, Week 16, Week 26, and Week 52
Total motor score, upper extremity motor score, and lower extremity motor score
Time frame: Week 4, Week 8, Week 16, Week 26, and Week 52
Neurological motor level (right and left) and motor zone of partial preservation (ZPP) (right and left)
Time frame: Week 4, Week 8, Week 16, Week 26, and Week 52
Change in motor score within the ZPP (right and left)
Time frame: Week 4, Week 8, Week 16, Week 26, and Week 52
Spinal cord independence measure (SCIM) total score, subscores and individual items
Time frame: Week 4, Week 8, Week 16, Week 26, and Week 52
Functional independence measure (FIM) total score, subscores and individual items
Time frame: Week 4, Week 8, Week 16, Week 26, and Week 52
Adverse events
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cethrin® (BA-210) in people with Acute Cervical Spinal Cord Injury, run by BioAxone BioSciences, Inc..
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 9 inclusion and 22 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: withdrawn, as of the sponsor's last update on 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 in ASIA motor score (time frame: week 26). The study lists 3 primary outcomes in all. 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 17 Jan 2014.