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

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ClinicalTrials.gov Identifier: NCT02537899
Recruitment Status : Recruiting
First Posted : September 2, 2015
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Moleac Pte Ltd.

August 27, 2015
September 2, 2015
August 16, 2018
June 2015
June 2019   (Final data collection date for primary outcome measure)
  • Spinal cord injury severity based on American Spinal Injury Association Impairment Scale [ Time Frame: 6 months ]
  • Motor recovery based on American Spinal Injury Association Impairment Scale motor score [ Time Frame: 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
Same as current
Complete list of historical versions of study NCT02537899 on ClinicalTrials.gov Archive Site
  • Spinal cord injury severity based on American Spinal Injury Association Impairment Scale [ Time Frame: 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 ]
  • Sensory recovery based on American Spinal Injury Association Impairment Scale sensory score [ Time Frame: 1, 3, 6, 12, 18, 24 months ]
  • Functional state based on Spinal Cord Independence Measure [ Time Frame: 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 ]
Same as current
Not Provided
Not Provided
 
Spinal Cord Injury - Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD
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.
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.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Spinal Cord Injury
Drug: NeuroAiD
Other Names:
  • MLC601
  • MLC901
Treatment
NeuroAiD
Intervention: Drug: NeuroAiD
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Same as current
June 2019
June 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact: Carine Laik, MD +6562113710 carine.laik@moleac.com
Contact: Robert Gan +6562113710 robert.gan@moleac.com
Malaysia
 
 
NCT02537899
SATURN2015
No
Not Provided
Not Provided
Moleac Pte Ltd.
Moleac Pte Ltd.
Not Provided
Study Chair: Ramesh Kumar, FRCS University Kebangsaan Malaysia Medical Centre
Moleac Pte Ltd.
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP