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

Spinal Cord Injury Clinical Trial

— SATURN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537899
• Other study ID #: SATURN2015
• Status: Completed
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: September 20, 2023

Study information

• Verified date: March 2024
• Source: Moleac Pte Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 20, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Drug:
• NeuroAiD

Locations

Country	Name	City	State
Malaysia	University Kebangsaan Malaysia Medical Centre	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Moleac Pte Ltd.

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spinal cord injury severity based on American Spinal Injury Association Impairment Scale		6 months
Primary	Motor recovery based on American Spinal Injury Association Impairment Scale motor score		6 months
Primary	Number of patients experiencing adverse events	Adverse events as individual events and according to organ system, severity, and relatedness	6 months
Secondary	Spinal cord injury severity based on American Spinal Injury Association Impairment Scale		1, 3, 12, 18, 24 months
Secondary	Motor recovery based on American Spinal Injury Association Impairment Scale motor score		1, 3, 12, 18, 24 months
Secondary	Sensory recovery based on American Spinal Injury Association Impairment Scale sensory score		1, 3, 6, 12, 18, 24 months
Secondary	Functional state based on Spinal Cord Independence Measure		1, 3, 6, 12, 18, 24 months
Secondary	Quality of life based on Short Form-8 Health Survey		1, 3, 6, 12, 18, 24 months