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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2024
• Main ID: NCT02537899
• Date of registration: 27/08/2015
• Prospective Registration: No
• Primary sponsor: Moleac Pte Ltd.
• Public title: Spinal Cord Injury - Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD SATURN
• Scientific title: A Case Series of Patients With Spinal Cord Injury Treated With Standard Therapies and NeuroAiD
• Date of first enrolment: April 2015
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02537899
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Malaysia

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Spinal Cord Injury

Intervention(s)

Drug: NeuroAiD

Primary Outcome(s)

Motor recovery based on American Spinal Injury Association Impairment Scale motor score [Time Frame: 6 months]

Spinal cord injury severity based on American Spinal Injury Association Impairment Scale [Time Frame: 6 months]

Number of patients experiencing adverse events [Time Frame: 6 months]

Secondary Outcome(s)

Sensory recovery based on American Spinal Injury Association Impairment Scale sensory score [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]

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

Functional state based on Spinal Cord Independence Measure [Time Frame: 1, 3, 6, 12, 18, 24 months]

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

Secondary ID(s)

SATURN2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors