Spinal Cord InjuryPhase 2/3NCT02053883
Cethrin in Acute Cervical Spinal Cord Injury
A Phase 2/3 study testing Cethrin (BA-210) in people with Spinal Cord Injury, run by BioAxone BioSciences, Inc..
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III study designed to evaluate the efficacy and safety of Cethrin as a treatment for acute cervical spinal cord injury. During the trial, high and low doses of Cethrin will be compared with placebo. Read more about this study
- Who is it for?
- Ages 18 to 62 years
- Conditions the study is for
- 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
- Jul 2015to May 2016
- Phase
- Phase 2/3
- 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 18 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females, ages 18-62, inclusive
- Acute cervical spinal cord injury at a neurological level of C4-C6
- AIS Grade A or B
- Scheduled to undergo decompression/stabilization surgery within five days of injury
- Written or verbal consent from patient or legally authorized representative that patient is able and willing to comply with the study protocol, including follow-up visits
Who cannot join
- Participation in any other clinical trial for acute SCI, including previous Cethrin trial
- Inability to receive study medication within five days of injury
- Acute SCI from gunshot or penetrating/stab wound; peripheral nerve injury; brachial plexus injury; complete spinal cord transection; or multifocal SCI
- Significant hemorrhage on MRI/CT scan
- Females who are breastfeeding or have a positive serum pregnancy test
- Body mass index (BMI) of ≥ 35 kg/m2 at screening
Show all 12Show fewer
- History of an adverse reaction to a fibrin sealant or its human or bovine components
- Use of intravenous heparin in previous 48 hours, aspirin-containing products in previous 24 hours, thrombolytics in previous 12 hours
- Hemophilia or other bleeding abnormality (platelet level lower than 100 X 109/L, activated partial thromboplastin time or international normalized ratio higher than the upper limit of normal, or baseline hematocrit lower than 0.25)
- Unconsciousness or other impairment that precludes reliable ASIA examination
- Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs
- Clinically significant pre-existing neurological, cardiac, respiratory, hepatic, or renal disease
About this study
Official title: A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Cethrin in Subjects With Acute Cervical Spinal Cord Injury
This is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III study designed to evaluate the efficacy and safety of Cethrin as a treatment for acute cervical spinal cord injury. During the trial, high and low doses of Cethrin will be compared with placebo.
- Conditions
- Spinal Cord Injury
- Being tested
- Cethrin (BA-210), Placebo
- Keywords
- SCI, spinal cord injury, biologic drug, rho, paralysis, paraplegia, tetraplegia, quadriplegia, trauma, central nervous system, fibrin sealant, neurosurgery, cervical, regeneration, neurotrauma
- Medical subject headings
- Spinal Cord Injuries, Night Blindness, Congenital Stationary, Autosomal Dominant 1, Paralysis, Paraplegia, Quadriplegia, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cethrin (BA-210)Drug
High or low doses of Cethrin administered extradurally in a fibrin sealant during spinal decompression/stabilization surgery.
PlaceboDrug
Fibrin sealant alone administered extradurally during spinal decompression/stabilization surgery.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Fibrin sealant only. Receives: Drug: Placebo |
| Cethrin (BA-210) - Low Dose | Experimental | Low dose of Cethrin in a fibrin sealant. Receives: Drug: Cethrin (BA-210) |
| Cethrin (BA-210) - High Dose | Experimental | High dose of Cethrin in a fibrin sealant. Receives: Drug: Cethrin (BA-210) |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery
Measured: Baseline to 6 Months
Secondary outcomes (7)
ASIA Total Motor Score Recovery
Measured: Baseline to 6 Months
ASIA Impairment Scale (AIS) Grade Recovery
Measured: Baseline to 6 Months
Motor Neurological Level Recovery
Measured: Baseline to 6 Months
ASIA Sensory Score Recovery
Measured: Baseline to 6 Months
Spinal Cord Independence Measure (SCIM) III (Total Score, Self-Care Subscore)
Measured: 6 Months
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Measured: 6 Months
Incidence of Adverse Events
Measured: 0-6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startJul 2015
- Primary completionMay 2016 (estimated)
Why it stopped: Compound recently partnered with another company for continued development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT02053883
- Sponsor's protocol ID
- BA-210-201
- Status last verified
- Nov 2014
- First submitted
- 31 Jan 2014
- Last updated
- 26 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Cethrin in Subjects With Acute Cervical Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02053883
- Acronym / sponsor ID
- BA-210-201
- Conditions
- Spinal Cord Injury
- Keywords
- SCI, spinal cord injury, biologic drug, rho, paralysis, paraplegia, tetraplegia, quadriplegia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Compound recently partnered with another company for continued development.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioAxone BioSciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- May 2016 (estimated)
- First posted
- 4 Feb 2014 (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/III study designed to evaluate the efficacy and safety of Cethrin as a treatment for acute cervical spinal cord injury. During the trial, high and low doses of Cethrin will be compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboFibrin sealant only. |
| Cethrin (BA-210) - Low Dose | Experimental | Drug: Cethrin (BA-210)Low dose of Cethrin in a fibrin sealant. |
| Cethrin (BA-210) - High Dose | Experimental | Drug: Cethrin (BA-210)High dose of Cethrin in a fibrin sealant. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males or females, ages 18-62, inclusive
- Acute cervical spinal cord injury at a neurological level of C4-C6
- AIS Grade A or B
- Scheduled to undergo decompression/stabilization surgery within five days of injury
- Written or verbal consent from patient or legally authorized representative that patient is able and willing to comply with the study protocol, including follow-up visits
Key exclusion criteria (12 listed)
- Participation in any other clinical trial for acute SCI, including previous Cethrin trial
- Inability to receive study medication within five days of injury
- Acute SCI from gunshot or penetrating/stab wound; peripheral nerve injury; brachial plexus injury; complete spinal cord transection; or multifocal SCI
- Significant hemorrhage on MRI/CT scan
- Females who are breastfeeding or have a positive serum pregnancy test
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)High or low doses of Cethrin administered extradurally in a fibrin sealant during spinal decompression/stabilization surgery. | Drug | Cethrin (BA-210) - High Dose, Cethrin (BA-210) - Low Dose |
| PlaceboFibrin sealant alone administered extradurally during spinal decompression/stabilization surgery. | Drug | Placebo |
Primary outcome
American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery
Time frame: Baseline to 6 Months
7 secondary outcomes
ASIA Total Motor Score Recovery
Time frame: Baseline to 6 Months
ASIA Impairment Scale (AIS) Grade Recovery
Time frame: Baseline to 6 Months
Motor Neurological Level Recovery
Time frame: Baseline to 6 Months
ASIA Sensory Score Recovery
Time frame: Baseline to 6 Months
Spinal Cord Independence Measure (SCIM) III (Total Score, Self-Care Subscore)
Time frame: 6 Months
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
Time frame: 6 Months
Incidence of Adverse Events
Time frame: 0-6 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 26 Nov 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 2/3 study testing Cethrin (BA-210) in people with 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 5 inclusion and 12 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 26 Nov 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 combined 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.
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?
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?
American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery (time frame: Baseline to 6 Months). 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 26 Nov 2014.