Spinal Cord Injury - Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD

Study Overview
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Brief Summary
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SATURN investigates the promising role of NeuroAiD in patients with spinal cord injury and will provide important information on the feasibility of conducting larger controlled trials.

Detailed Description
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SATURN is a prospective cohort study of patients with moderately-severe to severe spinal cord injury, defined as American Spinal Injury Association Impairment Scale A and B, who are treated with open-label NeuroAiD for 6 months in addition to standard care and followed for 24 months. Anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 using a secured online system and will include information on demographics, main diagnostics, neurological and functional state, treatment compliance, concomitant therapies, and side effects, if any.

Official Title
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A Case Series of Patients With Spinal Cord Injury Treated With Standard Therapies and NeuroAiD

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Drug: NeuroAiD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Age 18 to 65 years Diagnosed with spinal cord injury between 3 days and 4 weeks American Spinal Injury Association Impairment Scale A or B Informed consent for inclusion into the database is obtained Exclusion Criteria: Non survivable injury Multiple significant trauma (i.e. significant intracranial and extracranial injuries including limb fractures) that would limit observation of recovery from spinal cord injury Other conditions that would limit clinical assessment of outcomes (e.g. dementia, demyelinating disease, autoimmune disease, etc) Refusal of treatment or contraindication to NeuroAiD

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>NeuroAiD | Drug: NeuroAiD<br> <br> * Other names: MLC901;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal cord injury severity based on American Spinal Injury Association Impairment Scale |  | 6 months | 
| Motor recovery based on American Spinal Injury Association Impairment Scale motor score |  | 6 months | 
| Number of patients experiencing adverse events | Adverse events as individual events and according to organ system, severity, and relatedness | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal cord injury severity based on American Spinal Injury Association Impairment Scale |  | 1, 3, 12, 18, 24 months | 
| Motor recovery based on American Spinal Injury Association Impairment Scale motor score |  | 1, 3, 12, 18, 24 months | 
| Sensory recovery based on American Spinal Injury Association Impairment Scale sensory score |  | 1, 3, 6, 12, 18, 24 months | 
| Functional state based on Spinal Cord Independence Measure |  | 1, 3, 6, 12, 18, 24 months | 
| Quality of life based on Short Form-8 Health Survey |  | 1, 3, 6, 12, 18, 24 months |