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

March 12, 2024 updated by: Moleac Pte Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Wilayah Persekutuan Kuala Lumpur
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 56000
        • University Kebangsaan Malaysia Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment
NeuroAiD
Drug: NeuroAiD
Other Names:
  • MLC601
  • MLC901

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moleac Pte Ltd.

Investigators

  • Study Chair: Ramesh Kumar, FRCS, University Kebangsaan Malaysia Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

September 20, 2023

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

August 27, 2015

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimated)

September 2, 2015

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SATURN2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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