Study of NeuroAid In Enhancing Recovery After Stroke (TIERS)

Moleac

Status and phase

Completed

Phase 2

Conditions

Cerebral Infarction

Stroke

Treatments

Drug: Neuroaid

Drug: Neuroaid matched Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00721825

Moleac

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

21 to 80 years old

Volunteers

No 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