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NeuroAiD Safe Treatment Registry (NeST)

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ClinicalTrials.gov Identifier: NCT02536079
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : February 2, 2018
Sponsor:
Collaborator:
Moleac Pte Ltd.
Information provided by (Responsible Party):
CHIMES Society

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.

Condition or disease Intervention/treatment
Brain Injury NeuroAiD Use Drug: NeuroAiD

Detailed Description:
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. Participation is voluntary. Data collected are similar to information obtained during standard care and are prospectively entered by the participating physicians at baseline (before initialization of NeuroAiD) and during subsequent visits. The follow up visits are timed with clinical appointments. Anonymized data will be extracted and collectively analyzed. Initial target sample size for the registry is 2000.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: NeuroAiD Safe Treatment Registry
Study Start Date : June 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Intervention Details:
  • Drug: NeuroAiD
    Other Names:
    • MLC601
    • MLC901


Primary Outcome Measures :
  1. Number of patients experiencing adverse events [ Time Frame: 3 months ]
    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)


Secondary Outcome Measures :
  1. Functional status based on modified Rankin Scale [ Time Frame: 1, 2, 3 months ]
  2. Neurological status based on Glasgow Coma Scale [ Time Frame: 1, 2, 3 months ]
  3. Neurological status based on National Institute of Health Stroke Scale [ Time Frame: 1, 2, 3 months ]
  4. Cognitive status based on Short Orientation-Memory-Concentration Test [ Time Frame: 1, 2, 3 months ]

Other Outcome Measures:
  1. Number of patients complying to prescribed dosage of NeuroAiD [ Time Frame: 1, 2, 3 months ]
    Compliance assessed as "since last visit, taking NeuroAiD..." never, 'rarely,' 'sometimes,' 'often,' 'always.'



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Unwillingness to participate
  • Contraindication to NeuroAiD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536079


Contacts
Contact: Carine Laik, MD +6596202670 aishah.rustam@moleac.com
Contact: Robert Gan, MD +6562113710 robert.gan@chimes-society.org

Locations
Indonesia
National Brain Center Hospital Recruiting
Jakarta, Indonesia
Contact: Lyna Soertidewi         
Malaysia
University Kebangsaan Malaysia Medical Centre Recruiting
Kuala Lumpur, Malaysia
Contact: Ramesh Kumar         
Sponsors and Collaborators
CHIMES Society
Moleac Pte Ltd.
Investigators
Study Chair: Narayanaswamy Venketasubramanian, FRCP Raffles Neuroscience Centre, Raffles Hospital, Singapore
Principal Investigator: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CHIMES Society
ClinicalTrials.gov Identifier: NCT02536079     History of Changes
Other Study ID Numbers: NeST2014
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries