Therapy to enhance plasticity, Regeneration and functional recovery after acute spinal cord injury
- Conditions
- spinal cord injuryMedDRA version: 20.1 Level: PT Classification code 10041554 Term: Spinal cord injury cervical System Organ Class: 10022117 - Injury, poisoning and procedural complicationsMedDRA version: 20.1 Level: PT Classification code 10041552 Term: Spinal cord injury System Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2016-001227-31-DE
- Lead Sponsor
- niversity Zurich, University Hospital Balgrist, Spinal Cord Injury Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 132
1. Male or female, 18 through 70 years of age
2. Acute cervical spinal cord injury (SCI) (Neurological level of injury
C1 = lesion = C8) with confirmed classification of ASIA impairment
scale (AIS) A-D at screening and predicted upper
extremities motor score (UEMS) recovery of less than 41/50
(according to the URP prediction model)
3. 4-28 days post-injury (i.e. initiation of bolus injection within 4-28
days post-injury)
4. 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 show active initiation of breathing are allowed
(e.g. continuous positive airway pressure (CPAP))
5. Hemodynamically and clinically stable according to the acute SCI
condition at baseline
6. For patients of childbearing potential , use of reliable means of contraception
7. Written informed consent by patient before any study assessment
is performed. If the patient is only able to consent orally a witness
signs and confirms the patient’s consent,
8. Cooperation and willingness to complete all aspects of the study
9. Ability of subject to understand character and individual
consequences of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 132
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
1. Complete anatomical transection confirmed by magnetic resonance imaging (MRI).
2. Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds.
3. Multiple levels of clinically relevant spinal cord lesions.
4. Major brachial or lumbar plexus damage/trauma.
5. 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.
6. Other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known 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.
7. History of or an acute episode of Guillain-Barre syndrome.
8. History of recent (6 months) meningitis or meningoencephalitis.
9. History of refractory epilepsy.
10. Patients with uncontrolled bleeding diathesis and/or who require uninterrupted concomitant therapeutic anticoagulation (e.g. phenoprocoumon (Marcumar®), heparin/heparinoids and new oral anticoagulants) at a higher dose than for the prophylaxis of venous thromboembolism
11. Presence of any unstable medical or psychiatric condition (defined by the Diagnostic and Statistical Manual of Mental Disorders, Edition 4 (DSM-IV)) that could reasonably have been expected tosubject the patient to unwarranted risk from participation in the study or result in a significant deterioration of the patient's clinical course.
12. Drug dependence (as defined by DSM-IV) any time during the 6 month’s preceding study entry.
13. 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).
14. History of a life-threatening allergic or immune mediated reaction.
15. Patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections.
16. Inability to communicate effectively with the neurological examiner such that the validity of the patient's data could be compromised.
17. Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
18. Patients who are unconscious, including those patients who are unconscious due to medication causing marked sedation.
19. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method