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

NCT02537899 | Completed Phase 4

• 1 other identifier: SATURN2015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (3)

• Spinal cord injury severity based on American Spinal Injury Association Impairment Scale

  6 months

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

  6 months

• Number of patients experiencing adverse events

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

  6 months

Secondary Outcomes (5)

• Spinal cord injury severity based on American Spinal Injury Association Impairment Scale

  1, 3, 12, 18, 24 months

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

  1, 3, 12, 18, 24 months

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

  1, 3, 6, 12, 18, 24 months

• Functional state based on Spinal Cord Independence Measure

  1, 3, 6, 12, 18, 24 months

• Quality of life based on Short Form-8 Health Survey

  1, 3, 6, 12, 18, 24 months

Study Arms (1)

Treatment

OTHER

NeuroAiD

Drug: NeuroAiD

Interventions

NeuroAiD DRUG

Also known as: MLC601, MLC901

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Moleac Pte Ltd.: lead

Study Sites (1)

University Kebangsaan Malaysia Medical Centre

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (2)

• Kumar R, Htwe O, Baharudin A, Rhani SA, Ibrahim K, Nanra JS, Gsangaya M, Harun H, Kandar K, Balan M, Peh S, Pokharkar Y, Ingole A, Hisam Ariffin M. Spinal cord injury - assessing tolerability and use of combined rehabilitation and NeuroAiD (SATURN) study - primary results of an exploratory study. J Spinal Cord Med. 2023 Jul;46(4):682-686. doi: 10.1080/10790268.2022.2067972. Epub 2022 May 23.

  PMID: 35604343 DERIVED

• 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. doi: 10.2196/resprot.6275.

  PMID: 27919862 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Neuroaid

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 2, 2015
• Study Start: April 1, 2015
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

MY (1)