NCT02536079

Brief Summary

The NeST registry is a pro-active industry-academic collaboration to assess the use and safety of NeuroAiD in the real world setting. An online entry system was set up to allow easy data entry and retrieval of clinical information.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

10.5 years

First QC Date

August 26, 2015

Last Update Submit

February 15, 2023

Conditions

Brain InjuryNeuroAiD Use

Outcome Measures

Primary Outcomes (1)

  • Number of patients experiencing adverse events

    Adverse events categorized according to individual events, organ system, severity (mild, moderate, severe), and relatedness (based on WHO-World Health Organization - Uppsala Monitoring System as 'possibly' 'probably' or 'definitely' related)

    3 months

Secondary Outcomes (8)

  • Functional status based on modified Rankin Scale

    1, 2, 3 months

  • Neurological status based on Glasgow Coma Scale

    1, 2, 3 months

  • Neurological status based on National Institute of Health Stroke Scale

    1, 2, 3 months

  • Cognitive status based on Short Orientation-Memory-Concentration Test

    1, 2, 3 months

  • Cognitive status based on Mini-Mental State Examination (MMSE)

    3, 6,9, 12 months

  • +3 more secondary outcomes

Other Outcomes (4)

  • Number of patients complying to prescribed dosage of NeuroAiD

    1, 2, 3 months

  • Glasgow Outcome Scale Extended (GOS-E)

    1, 2, 3 months, additional visit

  • Rivermead Post-Concussion Symptom Questionnaire (RPQ)

    1, 2, 3 months, additional visit

  • +1 more other outcomes

Interventions

NeuroAiDDRUG
Also known as: MLC601, MLC901

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The NeST Registry is a product-specific and safety outcome registry that includes patients who are taking NeuroAiD. Participation is entirely voluntary and an agreement will be obtained before inclusion. The decision on the use of NeuroAiD should be made following a discussion between participant and physician and only then will the option of participation in the registry be considered.

You may qualify if:

  • Male or female
  • Any age
  • Taking, or has been prescribed NeuroAiD for any duration as judged by the physician and/or the participant
  • Agrees to be included in the registry and allows retrieval and analysis of data in accordance with local requirements

You may not qualify if:

  • Unwillingness to participate
  • Contraindication to NeuroAiD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Brain Center Hospital

Jakarta, Indonesia

RECRUITING

University Kebangsaan Malaysia Medical Centre

Kuala Lumpur, Malaysia

RECRUITING

Related Publications (1)

  • Venketasubramanian N, Kumar R, Soertidewi L, Abu Bakar A, Laik C, Gan R. The NeuroAiD Safe Treatment (NeST) Registry: a protocol. BMJ Open. 2015 Nov 13;5(11):e009866. doi: 10.1136/bmjopen-2015-009866.

    PMID: 26567259DERIVED

MeSH Terms

Conditions

Brain Injuries

Interventions

Neuroaid

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Narayanaswamy Venketasubramanian, FRCP

    Raffles Neuroscience Centre, Raffles Hospital, Singapore

    STUDY CHAIR

  • Ramesh Kumar, FRCS

    Department of Neurosurgery, Faculty of Medicine, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia

    PRINCIPAL INVESTIGATOR

  • Lyna Soertidewi, MD

    Department of Neurology, National Brain Center Hospital, Jakarta, Indonesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Lim

CONTACT

+6562113710emily.lim@moleac.com

Sylvain Durrleman, PhD

CONTACT

sylvain.durrleman@moleac.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2015

First Posted

August 31, 2015

Study Start

June 1, 2014

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations

ID(1)MY(1)