The NeuroAiD Safe Treatment (NeST) Registry: a protocol

Narayanaswamy Venketasubramanian, Ramesh Kumar, Lyna Soertidewi, Azizi Abu Bakar, Carine Laik, Robert Gan, Narayanaswamy Venketasubramanian, Ramesh Kumar, Lyna Soertidewi, Azizi Abu Bakar, Carine Laik, Robert Gan

Abstract

Introduction: NeuroAiD (MLC601, MLC901), a combination of natural products, has been shown to be safe and to aid neurological recovery after brain injuries. The NeuroAiD Safe Treatment (NeST) Registry aims to assess its use and safety in the real-world setting.

Methods and analysis: The NeST Registry is designed as a product registry that would provide information on the use and safety of NeuroAiD in clinical practice. An online NeST Registry was set up to allow easy entry and retrieval of essential information including demographics, medical conditions, clinical assessments of neurological, functional and cognitive state, compliance, concomitant medications, and side effects, if any, among patients on NeuroAiD. Patients who are taking or have been prescribed NeuroAiD may be included. Participation is voluntary. Data collected are similar to information obtained during standard care and are prospectively entered by the participating physicians at baseline (before initialisation of NeuroAiD) and during subsequent visits. The primary outcome assessed is safety (ie, non-serious and serious adverse event), while compliance and neurological status over time are secondary outcomes. The in-person follow-up assessments are timed with clinical appointments. Anonymised data will be extracted and collectively analysed. Initial target sample size for the registry is 2000. Analysis will be performed after every 500 participants entered with completed follow-up information.

Ethics and dissemination: Doctors who prescribe NeuroAiD will be introduced to the registry by local partners. The central coordinator of the registry will discuss the protocol and requirements for implementation with doctors who show interest. Currently, the registry has been approved by the Ethics Committees of Universiti Kebangsaan Malaysia (Malaysia) and National Brain Center (Indonesia). In addition, for other countries, Ethics Committee approval will be obtained in accordance with local requirements.

Trial registration number: NCT02536079.

Keywords: CLINICAL PHARMACOLOGY; REHABILITATION MEDICINE; STATISTICS & RESEARCH METHODS; STROKE MEDICINE.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
NeST Registry flow chart (GCS, Glasgow Coma Scale; mRS, modified Rankin Scale; NeST, NeuroAiD Safe Treatment; NIHSS, National Institutes of Health Stroke Scale; SOMCT, Short Orientation Memory Concentration Test).
Figure 2
Figure 2
Organisational structure of oversight of NeuroAiD Safe Treatment (NeST) Registry.

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