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Trial record 3 of 12 for:    NeuroAiD

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537899
Recruitment Status : Unknown
Verified September 2020 by Moleac Pte Ltd..
Recruitment status was:  Active, not recruiting
First Posted : September 2, 2015
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Moleac Pte Ltd.

Tracking Information
First Submitted Date  ICMJE August 27, 2015
First Posted Date  ICMJE September 2, 2015
Last Update Posted Date September 3, 2020
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spinal Cord Injury - Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD
Official Title  ICMJE A Case Series of Patients With Spinal Cord Injury Treated With Standard Therapies and NeuroAiD
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Drug: NeuroAiD
Other Names:
  • MLC601
  • MLC901
Study Arms  ICMJE Treatment
NeuroAiD
Intervention: Drug: NeuroAiD
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 28, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02537899
Other Study ID Numbers  ICMJE SATURN2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Moleac Pte Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Moleac Pte Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ramesh Kumar, FRCS University Kebangsaan Malaysia Medical Centre
PRS Account Moleac Pte Ltd.
Verification Date September 2020

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