Status:
COMPLETED
Study of NeuroAid In Enhancing Recovery After Stroke
Lead Sponsor:
Moleac Pte Ltd.
Conditions:
Stroke
Cerebral Infarction
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00721825
Start Date
January 1 2008
End Date
July 1 2008
Last Update
July 24 2008
Active Locations (1)
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1
Tan Tock Seng Rehabilitation department
Singapore, Singapore, 569766