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Study of NeuroAid In Enhancing Recovery After Stroke (TIERS)

Primary Purpose

Stroke, Cerebral Infarction

Status
Completed
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Neuroaid
Neuroaid matched Placebo
Sponsored by
Moleac Pte Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Cerebral infarct, Rehabilitation, Double blind Randomized, Placebo controlled, Traditional Chinese Medicine, Neuroaid

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject had cerebral infarction confirmed by Computed Tomography (CT scan or Magnetic Resonance Imaging (MRI) imaging
  • Presents within 1 month after stroke onset
  • Presents with motor power of from grade 1 - 4/5 in at least one limb
  • Has a pre-stroke modified Rankin score ≤ 1.
  • Age between 21 and 80 years old
  • Female subjects are eligible to participate in the trial if they are of non childbearing potential (hysterectomy or post-menopausal)
  • Subject or legally acceptable representative is willing and able to provide written informed consent
  • Subject and carer are willing and able to comply with investigational drug administration schedule.

Exclusion Criteria:

  • Subject has received thrombolysis
  • Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
  • Subject has definite indication for full-dose or long-term anticoagulation therapy
  • Subject has other significant non-ischemic brain lesion which could affect function disability
  • Subject has co-existing systemic diseases: terminal cancer, renal failure (creatinine >200 μmol/L, if known), cirrhosis, severe dementia or psychosis
  • Subject has a history of previous stroke/s
  • Subject has participated in another clinical trial within the last three months
  • Subject has aphasia or any other cognitive disabilities which prevent cooperation with study instructions
  • Subject has dense hemiplegia (grade 0 motor power)
  • Subject has haemoglobin level of <10mg/dl on admission
  • Subject has a history of craniotomy or seizures

Sites / Locations

  • Tan Tock Seng Rehabilitation department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Neuroaid

Neuroaid matched placebo

Outcomes

Primary Outcome Measures

Fugl-Meyer assessment

Secondary Outcome Measures

Functional Independence Measure (FIM) scale
Fugl-Meyer subscores
NIHSS and NIHSS subscores

Full Information

First Posted
July 22, 2008
Last Updated
July 23, 2008
Sponsor
Moleac Pte Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00721825
Brief Title
Study of NeuroAid In Enhancing Recovery After Stroke
Acronym
TIERS
Official Title
A Double-Blinded, Placebo-Controlled, Randomized Phase II Pilot Study to Investigate the Potential Efficacy of a Traditional Chinese Medicine NeuroAid In Enhancing Recovery After Stroke (TIERS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Moleac Pte Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
TIERS is a phase II to generate detailed preliminary data on the efficacy of NeuroAid in post-stroke recovery, and to assess the utility of the rehabilitation outcome measure instruments used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebral Infarction
Keywords
Stroke, Cerebral infarct, Rehabilitation, Double blind Randomized, Placebo controlled, Traditional Chinese Medicine, Neuroaid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Neuroaid
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Neuroaid matched placebo
Intervention Type
Drug
Intervention Name(s)
Neuroaid
Intervention Description
Neuroaid capsules, 4 capsules, three times per day, during one month
Intervention Type
Drug
Intervention Name(s)
Neuroaid matched Placebo
Intervention Description
Neuroaid matched placebo 4 capsules three times per day during one month
Primary Outcome Measure Information:
Title
Fugl-Meyer assessment
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Functional Independence Measure (FIM) scale
Time Frame
4 weeks and 8 weeks
Title
Fugl-Meyer subscores
Time Frame
4 weeks and 8 weeks
Title
NIHSS and NIHSS subscores
Time Frame
4 weeks and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject had cerebral infarction confirmed by Computed Tomography (CT scan or Magnetic Resonance Imaging (MRI) imaging Presents within 1 month after stroke onset Presents with motor power of from grade 1 - 4/5 in at least one limb Has a pre-stroke modified Rankin score ≤ 1. Age between 21 and 80 years old Female subjects are eligible to participate in the trial if they are of non childbearing potential (hysterectomy or post-menopausal) Subject or legally acceptable representative is willing and able to provide written informed consent Subject and carer are willing and able to comply with investigational drug administration schedule. Exclusion Criteria: Subject has received thrombolysis Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI Subject has definite indication for full-dose or long-term anticoagulation therapy Subject has other significant non-ischemic brain lesion which could affect function disability Subject has co-existing systemic diseases: terminal cancer, renal failure (creatinine >200 μmol/L, if known), cirrhosis, severe dementia or psychosis Subject has a history of previous stroke/s Subject has participated in another clinical trial within the last three months Subject has aphasia or any other cognitive disabilities which prevent cooperation with study instructions Subject has dense hemiplegia (grade 0 motor power) Subject has haemoglobin level of <10mg/dl on admission Subject has a history of craniotomy or seizures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keng He Kong, MD
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Rehabilitation department
City
Singapore
ZIP/Postal Code
569766
Country
Singapore

12. IPD Sharing Statement

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Study of NeuroAid In Enhancing Recovery After Stroke

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