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Trial record 2 of 12 for:    NeuroAiD

NeuroAiD Safe Treatment Registry (NeST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536079
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : August 2, 2021
Sponsor:
Collaborator:
Moleac Pte Ltd.
Information provided by (Responsible Party):
CHIMES Society

Tracking Information
First Submitted Date August 26, 2015
First Posted Date August 31, 2015
Last Update Posted Date August 2, 2021
Study Start Date June 2014
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2018)
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)
Original Primary Outcome Measures
 (submitted: August 26, 2015)
Number of adverse events and 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)
Change History
Current Secondary Outcome Measures
 (submitted: July 26, 2021)
  • Functional status based on modified Rankin Scale [ Time Frame: 1, 2, 3 months ]
    0 No symptoms at all
    1. No significant disability despite symptoms; able to carry out all usual duties and activities
    2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    3. Moderate disability; requiring some help, but able to walk without assistance
    4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    6. Dead
  • Neurological status based on Glasgow Coma Scale [ Time Frame: 1, 2, 3 months ]
    to assess level of consciousness: eye opening, Eye opening 4, Eye Opening Response
    • Spontaneous--open with blinking at baseline 4 points
    • To verbal stimuli, command, speech 3 points
    • To pain only (not applied to face) 2 points
    • No response 1 point;Verbal Response
    • Oriented 5 points
    • Confused conversation, but able to answer questions 4 points
    • Inappropriate words 3 points
    • Incomprehensible speech 2 points
    • No response 1 point;Verbal Response
    • Oriented 5 points
    • Confused conversation, but able to answer questions 4 points
    • Inappropriate words 3 points
    • Incomprehensible speech 2 points
    • No response 1 point;Motor Response
    • Obeys commands for movement 6 points
    • Purposeful movement to painful stimulus 5 points
    • Withdraws in response to pain 4 points
    • Flexion in response to pain (decorticate posturing) 3 points
    • Extension response in response to pain (decerebrate rigidity )
  • Neurological status based on National Institute of Health Stroke Scale [ Time Frame: 1, 2, 3 months ]
    Quantify impairment caused by stroke 0- no stroke, 1-4 Minor stroke, 5-15 Moderate,16-20 Moderate to Severe stroke, 21-42 severe stroke
  • Cognitive status based on Short Orientation-Memory-Concentration Test [ Time Frame: 1, 2, 3 months ]
    test involves 6 items test -1.what year is it now?2.What month is it now?3.Repeat phrase, about what time is it ? (within one hour),Count backwards 20 to 1,Say months in reversw order,repeat phrase just given,
  • Cognitive status based on Mini-Mental State Examination (MMSE) [ Time Frame: 3, 6,9, 12 months ]
    Orientation, Registration,Attention and Calculation,Recall, Language, Copying,
  • Cognitive status based on Alzheimer's Disease Assessment Scale- cognitive subscale (ADAS-cog) [ Time Frame: 3, 6, 9, 12 months ]
    World recall, Naming of objects and fingers,Commands,Constructional Praxis,Ideational Praxis,Orientation, World Recognition,Language,Comprehension of spoken language,Word finding difficulty, Remembering test instructions
  • Cognitive status based on Montreal Cognitive Assessment (MoCA) [ Time Frame: 3, 6, 9, 12 months ]
    Visio spatial /executive,naming, memory ,attention , language,abstraction, delayed recall
  • Functional outcome based on Bristol Activities of Daily Living (BADL) [ Time Frame: 3, 6, 9, 12 ]
    Preparing Food 3 Eating 3 Preparing Drink 3 Drinking 3 Dressing 3 Hygiene 3 Teeth 3 Bath/Shower 3 Toilet/Commode 3 Transfers 3 Mobility 3 Orientation - Time 3 Orientation - Space 3 Communication 3 Telephone 3 Housework/Gardening 3 Shopping 3 Finances 3 Games/Hobbies 3 Transport 3
Original Secondary Outcome Measures
 (submitted: August 26, 2015)
  • Functional status based on modified Rankin Scale [ Time Frame: 1, 2, 3 months ]
  • Neurological status based on Glasgow Coma Scale [ Time Frame: 1, 2, 3 months ]
  • Neurological status based on National Institute of Health Stroke Scale [ Time Frame: 1, 2, 3 months ]
  • Cognitive status based on Short Orientation-Memory-Concentration Test [ Time Frame: 1, 2, 3 months ]
Current Other Pre-specified Outcome Measures
 (submitted: August 26, 2015)
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.'
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title NeuroAiD Safe Treatment Registry
Official Title NeuroAiD Safe Treatment Registry
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.
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]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Months
Biospecimen Not Provided
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.
Condition
  • Brain Injury
  • NeuroAiD Use
Intervention Drug: NeuroAiD
Other Names:
  • MLC601
  • MLC901
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 26, 2015)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Emily Lim +6562113710 ext 3184 emily.lim@moleac.com
Contact: Sylvain Durrleman, PhD sylvain.durrleman@moleac.com
Listed Location Countries Indonesia,   Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number NCT02536079
Other Study ID Numbers NeST2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party CHIMES Society
Original Responsible Party Same as current
Current Study Sponsor CHIMES Society
Original Study Sponsor Same as current
Collaborators 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
PRS Account CHIMES Society
Verification Date July 2021