Study of NeuroAid In Enhancing Recovery After Stroke (TIERS)

This study has been completed.
Sponsor:
Information provided by:
Moleac Pte Ltd.
ClinicalTrials.gov Identifier:
NCT00721825
First received: July 22, 2008
Last updated: July 23, 2008
Last verified: July 2008
  Purpose

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 Intervention Phase
Stroke
Cerebral Infarction
Drug: Neuroaid
Drug: Neuroaid matched Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Moleac Pte Ltd.:

Primary Outcome Measures:
  • Fugl-Meyer assessment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Independence Measure (FIM) scale [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
  • Fugl-Meyer subscores [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
  • NIHSS and NIHSS subscores [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721825

Locations
Singapore
Tan Tock Seng Rehabilitation department
Singapore, Singapore, 569766
Sponsors and Collaborators
Moleac Pte Ltd.
Investigators
Principal Investigator: Keng He Kong, MD Tan Tock Seng Hospital
  More Information

No publications provided

Responsible Party: Dr Kong Keng He - senior consultant, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT00721825     History of Changes
Other Study ID Numbers: Moleac
Study First Received: July 22, 2008
Last Updated: July 23, 2008
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Moleac Pte Ltd.:
Stroke
Cerebral infarct
Rehabilitation
Double blind Randomized
Placebo controlled
Traditional Chinese Medicine
Neuroaid

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on August 01, 2014