NCT00721825CompletedPhase 2
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Moleac Pte Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Fugl-Meyer assessment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ≤
- •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
Arms & Interventions
1
Active Comparator
Neuroaid
Intervention: Neuroaid (Drug)
2
Placebo Comparator
Neuroaid matched placebo
Intervention: Neuroaid matched Placebo (Drug)
Outcomes
Primary Outcomes
Fugl-Meyer assessment
Time Frame: 4 weeks
Secondary Outcomes
- Functional Independence Measure (FIM) scale(4 weeks and 8 weeks)
- Fugl-Meyer subscores(4 weeks and 8 weeks)
- NIHSS and NIHSS subscores(4 weeks and 8 weeks)
Investigators
Study Sites (1)
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