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

Primary Purpose

Spinal Cord Injury

Status
Active
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
NeuroAiD
Sponsored by
Moleac Pte Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Kebangsaan Malaysia Medical Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

NeuroAiD

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Spinal cord injury severity based on American Spinal Injury Association Impairment Scale
Motor recovery based on American Spinal Injury Association Impairment Scale motor score
Sensory recovery based on American Spinal Injury Association Impairment Scale sensory score
Functional state based on Spinal Cord Independence Measure
Quality of life based on Short Form-8 Health Survey

Full Information

First Posted
August 27, 2015
Last Updated
March 14, 2023
Sponsor
Moleac Pte Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02537899
Brief Title
Spinal Cord Injury - Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD
Acronym
SATURN
Official Title
A Case Series of Patients With Spinal Cord Injury Treated With Standard Therapies and NeuroAiD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2015 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moleac Pte Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm Description
NeuroAiD
Intervention Type
Drug
Intervention Name(s)
NeuroAiD
Other Intervention Name(s)
MLC601, MLC901
Primary Outcome Measure Information:
Title
Spinal cord injury severity based on American Spinal Injury Association Impairment Scale
Time Frame
6 months
Title
Motor recovery based on American Spinal Injury Association Impairment Scale motor score
Time Frame
6 months
Title
Number of patients experiencing adverse events
Description
Adverse events as individual events and according to organ system, severity, and relatedness
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Spinal cord injury severity based on American Spinal Injury Association Impairment Scale
Time Frame
1, 3, 12, 18, 24 months
Title
Motor recovery based on American Spinal Injury Association Impairment Scale motor score
Time Frame
1, 3, 12, 18, 24 months
Title
Sensory recovery based on American Spinal Injury Association Impairment Scale sensory score
Time Frame
1, 3, 6, 12, 18, 24 months
Title
Functional state based on Spinal Cord Independence Measure
Time Frame
1, 3, 6, 12, 18, 24 months
Title
Quality of life based on Short Form-8 Health Survey
Time Frame
1, 3, 6, 12, 18, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramesh Kumar, FRCS
Organizational Affiliation
University Kebangsaan Malaysia Medical Centre
Official's Role
Study Chair
Facility Information:
Facility Name
University Kebangsaan Malaysia Medical Centre
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia

12. IPD Sharing Statement

Citations:
PubMed Identifier
35604343
Citation
Kumar R, Htwe O, Baharudin A, Rhani SA, Ibrahim K, Nanra JS, Gsangaya M, Harun H, Kandar K, Balan M, Peh S, Pokharkar Y, Ingole A, Hisam Ariffin M. Spinal cord injury - assessing tolerability and use of combined rehabilitation and NeuroAiD (SATURN) study - primary results of an exploratory study. J Spinal Cord Med. 2023 Jul;46(4):682-686. doi: 10.1080/10790268.2022.2067972. Epub 2022 May 23.
Results Reference
derived
PubMed Identifier
27919862
Citation
Kumar R, Htwe O, Baharudin A, Ariffin MH, Abdul Rhani S, Ibrahim K, Rustam A, Gan R. Spinal Cord Injury-Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN Study): Protocol of An Exploratory Study In Assessing the Safety and Efficacy of NeuroAiD Amongst People Who Sustain Severe Spinal Cord Injury. JMIR Res Protoc. 2016 Dec 5;5(4):e230. doi: 10.2196/resprot.6275.
Results Reference
derived

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

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