Acute Spinal Cord InjuryPhase 1NCT00406016
Acute Safety, Tolerability, Feasibility and Pharmacokinetics of Intrath. Administered ATI355 in Patients With Acute SCI
A Phase 1 study testing ATI355 in people with Acute Spinal Cord Injury, run by Novartis at 14 sites in 3 countries.
Trial summary
This study will evaluate the acute safety, tolerability, feasibility and pharmacokinetics of 6 dose regimens of ATI355 in acute spinal cord injury patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Spinal Cord Injury
- What is being tested?
- ATI355
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 14 sitesin 3 countries
- Study dates
- May 2006to Sep 2011
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute spinal cord injury paraplegic and tetraplegic patients with confirmed classification of ASIA A (C5 ≤ lesion ≤ T12; 4-14 days post-injury (i.e. study drug treatment must begin 4-14 days post injury) for paraplegic patients and for those tetraplegic patients who do not require artificial respiration at time of treatment initiation within the 4-14 days time interval. In those tetraplegic patients who still require artificial respiration in the 4-14 days time interval treatment can be initiated up to 60 days post-injury as soon as the patient is weaned off the respiratory machine.)
- Tetraplegic patients who were initially diagnosed as ASIA A (neurologically complete lesion) at screening and turned into ASIA B (neurologically incomplete lesion) at baseline.
- Hemodynamically stable (at baseline).
- For female patients of child bearing potential, written agreement to abstain from intercourse during the first 12 weeks of the study and then subsequent use of a double-barrier local contraception, i.e. intra-uterine device plus condom, or spermicidal gel plus condom for up to one year post study drug treatment. Patients must receive documented counseling on contraceptive measures.
- For Cohort 5: Acute spinal cord injury tetraplegic patients with confirmed classification of ASIA A: Cervical lesions (C5 ≤ lesion ≤ T1). 4-28 days post-injury (i.e. study drug treatment must begin 4-28 days post injury). Tetraplegic patients who are allowed to start treatment are those who either do not require mechanical ventilation or who do not completely depend on mechanical ventilation but show some degree of spontaneous ventilation. Only those modes of ventilation where the patient must initiate all breaths are allowed (e.g. continuous positive airway pressure [CPAP]).
Who cannot join
- Complete anatomical transection confirmed by MRI or trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds.
- Magnetic Resonance Imaging (MRI) indicating complete obstruction of the intrathecal space.
- Presence of one of the following:
- multiple spinal cord lesions
- cauda equina damage
- major brachial or lumbar plexus damage/trauma
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- significant head trauma (e.g. cortical damage/lesion), or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function or otherwise compromise the validity of the patient's data.
- Other significant preexisting or current systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including human immunodeficiency virus [HIV]) or kidney disease; or active malignancy or any other condition as determined by history or laboratory investigation that could cause a neurological deficit including syphilis, myelopathy, clinically relevant polyneuropathy, etc.
- History of meningitis, meningoencephalitis, epilepsy or life-threatening allergic or immune-mediated reaction.
- History of or current autoimmune disease or an acute episode of Guillain-Barre syndrome.
- Patients with uncontrolled bleeding diathesis and/or on concomitant treatment with coumarin anticoagulant.
- Presence of any unstable medical or psychiatric condition (defined by the Diagnostic and Statistical Manual of Mental Disorders-IV [DSM-IV]) that could reasonably have been expected to subject the patient to unwarranted risk from participation in the study or result in a significant deterioration of the patient's clinical course.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/ml).
- Hemoglobin levels below 8.0 g/dl and/or patients who required greater than 10 (ten) blood transfusions since the acute injury
- Patients with concomitant treatment with Metamizole from Screening until end of Follow Up phase
- Mechanical ventilation will be allowed for patients in Cohort 5, the patient must not depend completely on the ventilation but should show some degree of spontaneous ventilation. Only those modes of ventilation where the patient must initiate all breaths are allowed (e.g. continuous positive airway pressure [CPAP]).
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Germany9 sites
Novartis Investigative site
Bad Wildungen, 34537
Novartis Investigative site
Bayreuth, 09445
Novartis Investigative site
Bochum, 44789
Novartis Investigative site
Hamburg, 21033
Novartis Investigative site
Heidelberg, 69118
Novartis Investigative site
Karlsbad-Lagensteinbach, 76307
Novartis Investigative site
Murnau am Staffelsee, 82418
Novartis Investigative site
Tübingen, 72076
Novartis Investigative site
Ulm, 89081
Canada4 sites
Novartis Investigative site
Calgary
Novartis Investigative site
Montreal
Novartis Investigative site
Toronto
Novartis Investigative site
Vancouver
About this study
Official title: A Multi-center, Open-label, Cohort Study to Assess Feasibility, Acute Safety, Tolerability and Pharmacokinetics of 4 Dose Regimens of Continuous Intrathecal ATI355 Infusion and Two Regimen of Repeated Intrathecal Bolus Injections in Acute Spinal Cord Injury Paraplegic and Tetraplegic Patients
This study will evaluate the acute safety, tolerability, feasibility and pharmacokinetics of 6 dose regimens of ATI355 in acute spinal cord injury patients
- Conditions
- Acute Spinal Cord Injury
- Being tested
- ATI355
- Keywords
- Acute spinal cord injury;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATI355Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ATI355 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, Safety and Tolerability of a continuous intrathecal (i.t.) infusion or i.t. repeated bolus injections of ATI355 in patients with acute spinal cord injury at every visit and Assessment of serum and CSF pharmacokinetics at predefined visits.
Measured: 1 year
Secondary outcomes (2)
Immunogenicity of ATI355 in acute spinal cord injury patients up to one year.
Measured: 1 year
Early potential signal of efficacy by the American Spinal Cord Injury Association (ASIA) protocol and pharmacodynamic changes assessed by electrophysiology tests for up to one year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startMay 2006
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406016
- Sponsor's protocol ID
- CATI355A2102
- Status last verified
- Nov 2011
- First submitted
- 30 Nov 2006
- Last updated
- 11 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Cohort Study to Assess Feasibility, Acute Safety, Tolerability and Pharmacokinetics of 4 Dose Regimens of Continuous Intrathecal ATI355 Infusion and Two Regimen of Repeated Intrathecal Bolus Injections in Acute Spinal Cord Injury Paraplegic and Tetraplegic Patients
- ClinicalTrials.gov ID
- NCT00406016
- Acronym / sponsor ID
- CATI355A2102
- Conditions
- Acute Spinal Cord Injury
- Keywords
- Acute spinal cord injury;
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Dec 2006 (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 study will evaluate the acute safety, tolerability, feasibility and pharmacokinetics of 6 dose regimens of ATI355 in acute spinal cord injury patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ATI355 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute spinal cord injury paraplegic and tetraplegic patients with confirmed classification of ASIA A (C5 ≤ lesion ≤ T12; 4-14 days post-injury (i.e. study drug treatment must begin 4-14 days post injury) for paraplegic patients and for those tetraplegic patients who do not require artificial respiration at time of treatment initiation within the 4-14 days time interval. In those tetraplegic patients who still require artificial respiration in the 4-14 days time interval treatment can be initiated up to 60 days post-injury as soon as the patient is weaned off the respiratory machine.)
- Tetraplegic patients who were initially diagnosed as ASIA A (neurologically complete lesion) at screening and turned into ASIA B (neurologically incomplete lesion) at baseline.
- Hemodynamically stable (at baseline).
- For female patients of child bearing potential, written agreement to abstain from intercourse during the first 12 weeks of the study and then subsequent use of a double-barrier local contraception, i.e. intra-uterine device plus condom, or spermicidal gel plus condom for up to one year post study drug treatment. Patients must receive documented counseling on contraceptive measures.
- For Cohort 5: Acute spinal cord injury tetraplegic patients with confirmed classification of ASIA A: Cervical lesions (C5 ≤ lesion ≤ T1). 4-28 days post-injury (i.e. study drug treatment must begin 4-28 days post injury). Tetraplegic patients who are allowed to start treatment are those who either do not require mechanical ventilation or who do not completely depend on mechanical ventilation but show some degree of spontaneous ventilation. Only those modes of ventilation where the patient must initiate all breaths are allowed (e.g. continuous positive airway pressure [CPAP]).
Key exclusion criteria (17 listed)
- Complete anatomical transection confirmed by MRI or trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds.
- Magnetic Resonance Imaging (MRI) indicating complete obstruction of the intrathecal space.
- Presence of one of the following:
- multiple spinal cord lesions
- cauda equina damage
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 |
|---|---|---|
| ATI355 | Drug | 1 |
Primary outcome
Feasibility, Safety and Tolerability of a continuous intrathecal (i.t.) infusion or i.t. repeated bolus injections of ATI355 in patients with acute spinal cord injury at every visit and Assessment of serum and CSF pharmacokinetics at predefined visits.
Time frame: 1 year
2 secondary outcomes
Immunogenicity of ATI355 in acute spinal cord injury patients up to one year.
Time frame: 1 year
Early potential signal of efficacy by the American Spinal Cord Injury Association (ASIA) protocol and pharmacodynamic changes assessed by electrophysiology tests for up to one year.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATI355 in people with Acute Spinal Cord Injury, run by Novartis at 14 sites in 3 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 5 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 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Canada, Switzerland. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility, Safety and Tolerability of a continuous intrathecal (i.t.) infusion or i.t. repeated bolus injections of ATI355 in patients with acute spinal cord injury at every visit and Assessment of serum and CSF pharmacokinetics at predefined visits. (time frame: 1 year). 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 11 Feb 2020.