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Trial record 48 of 284 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

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 : September 2, 2015
Sponsor:
Information provided by (Responsible Party):

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
Spinal Cord Injury Drug: NeuroAiD 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  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : June 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 [ 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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537899


Contacts
Contact: Carine Laik, MD +6562113710 carine.laik@moleac.com
Contact: Robert Gan +6562113710 robert.gan@moleac.com

Locations
Malaysia
University Kebangsaan Malaysia Medical Centre Recruiting
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 56000
Contact: Ramesh Kumar         
Sub-Investigator: Ramesh Kumar         
Sub-Investigator: Ohnmar Htwe         
Principal Investigator: Shaharuddin Abd. Rhani         
Sub-Investigator: Azmi Baharudin         
Sub-Investigator: Mohd. Hisam Ariffin         
Sub-Investigator: Kamalnizat Ibrahim         
Sponsors and Collaborators
Moleac Pte Ltd.
Investigators
Study Chair: Ramesh Kumar, FRCS University Kebangsaan Malaysia Medical Centre
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Moleac Pte Ltd.
ClinicalTrials.gov Identifier: NCT02537899     History of Changes
Other Study ID Numbers: SATURN2015
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System