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

Sponsor
Moleac Pte Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02537899
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
80.1
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Case Series of Patients With Spinal Cord Injury Treated With Standard Therapies and NeuroAiD
Study Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Treatment

NeuroAiD

Drug: NeuroAiD
Other Names:
  • MLC601
  • MLC901

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Spinal cord injury severity based on American Spinal Injury Association Impairment Scale [6 months]

    2. Motor recovery based on American Spinal Injury Association Impairment Scale motor score [6 months]

    3. Number of patients experiencing adverse events [6 months]

      Adverse events as individual events and according to organ system, severity, and relatedness

    Secondary Outcome Measures

    1. Spinal cord injury severity based on American Spinal Injury Association Impairment Scale [1, 3, 12, 18, 24 months]

    2. Motor recovery based on American Spinal Injury Association Impairment Scale motor score [1, 3, 12, 18, 24 months]

    3. Sensory recovery based on American Spinal Injury Association Impairment Scale sensory score [1, 3, 6, 12, 18, 24 months]

    4. Functional state based on Spinal Cord Independence Measure [1, 3, 6, 12, 18, 24 months]

    5. Quality of life based on Short Form-8 Health Survey [1, 3, 6, 12, 18, 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Kebangsaan Malaysia Medical Centre Kuala Lumpur Wilayah Persekutuan Kuala Lumpur Malaysia 56000

    Sponsors and Collaborators

    • Moleac Pte Ltd.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Moleac Pte Ltd.
    ClinicalTrials.gov Identifier:
    NCT02537899
    Other Study ID Numbers:
    • SATURN2015
    First Posted:
    Sep 2, 2015
    Last Update Posted:
    Sep 3, 2020
    Last Verified:
    Sep 1, 2020
    Additional relevant MeSH terms:
    Spinal Cord Injuries
    Wounds and Injuries

    Study Results

    No Results Posted as of Sep 3, 2020