TIERS: Study of NeuroAid In Enhancing Recovery After Stroke

Sponsor

Moleac Pte Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT00721825

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Cerebral Infarction	Drug: Neuroaid Drug: Neuroaid matched Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Neuroaid	Drug: Neuroaid Neuroaid capsules, 4 capsules, three times per day, during one month
Placebo Comparator: 2 Neuroaid matched placebo	Drug: Neuroaid matched Placebo Neuroaid matched placebo 4 capsules three times per day during one month

Arm

Intervention/Treatment

Active Comparator: 1

Neuroaid

Drug: Neuroaid

Neuroaid capsules, 4 capsules, three times per day, during one month

Placebo Comparator: 2

Neuroaid matched placebo

Drug: Neuroaid matched Placebo

Neuroaid matched placebo 4 capsules three times per day during one month

Outcome Measures

Primary Outcome Measures

Fugl-Meyer assessment [4 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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