Spinal Cord InjuryPhase 4SATURNNCT02537899

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

A Phase 4 study testing NeuroAiD in people with Spinal Cord Injury, run by Moleac Pte Ltd. at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Spinal Cord Injury
What is being tested?: NeuroAiD
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteMalaysia
Study dates: Apr 2015to 20 Sep 2023
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

University Kebangsaan Malaysia Medical Centre
Kuala Lumpur, Kuala Lumpur, 56000

Other trials in Malaysia

About this study

Official title: 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.

Read the 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.

Conditions: Spinal Cord Injury
Being tested: NeuroAiD
Medical subject headings: Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NeuroAiDDrug
Also called MLC601, MLC901

Study groups in NCT02537899
Study group	Role	What they receive
Treatment	Other	NeuroAiD Receives: Drug: NeuroAiD

What is being measured

The primary outcome is the main question the study is designed to answer.

Spinal cord injury severity based on American Spinal Injury Association Impairment Scale
Measured: 6 months
Motor recovery based on American Spinal Injury Association Impairment Scale motor score
Measured: 6 months
Number of patients experiencing adverse events
Adverse events as individual events and according to organ system, severity, and relatedness
Measured: 6 months

Secondary outcomes (5)

Spinal cord injury severity based on American Spinal Injury Association Impairment Scale
Measured: 1, 3, 12, 18, 24 months
Motor recovery based on American Spinal Injury Association Impairment Scale motor score
Measured: 1, 3, 12, 18, 24 months
Sensory recovery based on American Spinal Injury Association Impairment Scale sensory score
Measured: 1, 3, 6, 12, 18, 24 months
Functional state based on Spinal Cord Independence Measure
Measured: 1, 3, 6, 12, 18, 24 months
Quality of life based on Short Form-8 Health Survey
Measured: 1, 3, 6, 12, 18, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201520 Sep 2023

First posted2 Sep 2015 (estimated)
Study startApr 2015
Primary completion20 Sep 2023
Study completion20 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02537899
Sponsor's protocol ID: SATURN2015
Acronym: SATURN
Status last verified: Mar 2024
First submitted: 27 Aug 2015
Last updated: 15 Mar 2024
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 35604343
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.
PubMed 27919862

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
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Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury

All Spinal Cord Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Case Series of Patients With Spinal Cord Injury Treated With Standard Therapies and NeuroAiD
ClinicalTrials.gov ID: NCT02537899
Acronym / sponsor ID: SATURN / SATURN2015
Conditions: Spinal Cord Injury
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Moleac Pte Ltd.Industry (pharma, biotech, devices)
Study start: Apr 2015 (actual)
Primary completion: 20 Sep 2023 (actual)
Study completion: 20 Sep 2023 (actual)
First posted: 2 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Other	Drug: NeuroAiDNeuroAiD

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NeuroAiDAlso: MLC601, MLC901	Drug	Treatment

Primary outcome

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

5 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Derived from this study: PubMed 35604343Kumar 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.
Derived from this study: PubMed 27919862Kumar 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.

Related trials for Spinal Cord Injury

Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing NeuroAiD in people with Spinal Cord Injury, run by Moleac Pte Ltd. at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spinal cord injury severity based on American Spinal Injury Association Impairment Scale (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02537899, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.