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Completed

NCT Number: NCT02537899

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

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Kebangsaan Malaysia Medical Centre

Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeuroAid

Drug

Other names: MLC601, MLC901

Primary outcomes

  1. Spinal cord injury severity based on American Spinal Injury Association Impairment Scale

    Time frame: 6 months

  2. Motor recovery based on American Spinal Injury Association Impairment Scale motor score

    Time frame: 6 months

  3. Number of patients experiencing adverse events

    Time frame: 6 months

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

Secondary outcomes

  1. Spinal cord injury severity based on American Spinal Injury Association Impairment Scale

    Time frame: 1, 3, 12, 18, 24 months

  2. Motor recovery based on American Spinal Injury Association Impairment Scale motor score

    Time frame: 1, 3, 12, 18, 24 months

  3. Sensory recovery based on American Spinal Injury Association Impairment Scale sensory score

    Time frame: 1, 3, 6, 12, 18, 24 months

  4. Functional state based on Spinal Cord Independence Measure

    Time frame: 1, 3, 6, 12, 18, 24 months

  5. Quality of life based on Short Form-8 Health Survey

    Time frame: 1, 3, 6, 12, 18, 24 months

Sponsors and collaborators

Lead sponsor

Moleac Pte Ltd.

Industry

Registry information

Official study title

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

Acronym: SATURN

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Sep 2, 2015
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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