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

Phase 4

Completed

• Conditions: Spinal Cord Injury
• Interventions: Drug: NeuroAiD

• Registration Number: NCT02537899
• Lead Sponsor: Moleac Pte Ltd.

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-08-28
• Study First Posted: 2015-09-02
• Primary Completion: 2023-09-20
• Study Completion: 2023-09-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	NeuroAiD	NeuroAiD

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Kebangsaan Malaysia Medical Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia