Study of NeuroAid In Enhancing Recovery After Stroke

Phase 2

Completed

• Conditions: Stroke; Cerebral Infarction
• Interventions: Drug: Neuroaid; Drug: Neuroaid matched Placebo

• Registration Number: NCT00721825
• Lead Sponsor: Moleac Pte Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Status Verified: 2008-07
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2008-07-22
• Study First Submitted QC: 2008-07-23
• Last Update Submitted: 2008-07-23
• Study First Posted: 2008-07-24
• Last Update Posted: 2008-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Neuroaid	Neuroaid
2	Neuroaid matched Placebo	Neuroaid matched placebo

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer assessment	4 weeks

Secondary Outcome Measures

Name	Time	Method
NIHSS and NIHSS subscores	4 weeks and 8 weeks
Functional Independence Measure (FIM) scale	4 weeks and 8 weeks
Fugl-Meyer subscores	4 weeks and 8 weeks

Trial Locations

Locations (1)

Tan Tock Seng Rehabilitation department; 🇸🇬 Singapore, Singapore