Study of NeuroAid In Enhancing Recovery After Stroke

NCT00721825 | Completed Phase 2

• 1 other identifier: Moleac
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cerebral Infarction

Keywords

Stroke; Cerebral infarct; Rehabilitation; Double blind Randomized; Placebo controlled; Traditional Chinese Medicine; Neuroaid

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer assessment

  4 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Neuroaid

Drug: Neuroaid

2

PLACEBO COMPARATOR

Neuroaid matched placebo

Drug: Neuroaid matched Placebo

Interventions

Neuroaid DRUG

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

1

Neuroaid matched Placebo DRUG

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

2

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Moleac Pte Ltd.: lead

Study Sites (1)

Tan Tock Seng Rehabilitation department

Singapore, 569766, Singapore

Location

MeSH Terms

Conditions

Stroke; Cerebral Infarction

Interventions

Neuroaid

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Keng He Kong, MD

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 24, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 24, 2008

Record last verified: 2008-07

Locations

SG (1)