Study of NeuroAid In Enhancing Recovery After Stroke

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Moleac Pte Ltd.

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