Chimes Society

The protocol is also available on www.ClinicalTrials.gov under the identifier NCT00554723.

Study Objective
To test the hypothesis that Neuroaid is superior to Placebo in reducing neurological deficit and improving functional outcome in patients with cerebral infarction of an intermediate range of severity (6 ≤ NIHSS ≤ 14).

Study Population
Potential subjects are screened for eligibility at baseline.

Inclusion criteria:
A subject will be eligible for inclusion in the trial only if all the following criteria apply at baseline:

• Subject is aged 18 years old and above
• Subject is on anti-platelet therapy
• Subject has a pre-stroke Modified Rankin Scale inferior or equal to 1
• A female subject is eligible to participate in the trial if she is of non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal)
• Subjects or his/her legally acceptable representative is willing to provide written informed consent
• Subject has a cerebral infarction with compatible imaging using Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI)
• Time window is less than 72 hours after symptoms onset
• Subject has cerebral infarction with an intermediate severity range 6≤NIHSS≤14

Exclusion criteria:
A subject will not be eligible for inclusion in the trial if any of the following criteria apply at baseline:

• Subjects deemed unstable by investigator after thrombolysis treatment
• Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
• Subject has a rapidly improving neurological deficit
• Subject has definite indication for full-dose or long-term anticoagulation therapy
• Subject has other significant non-ischemic brain lesion which could affect function or disability
• Subject has co-existing systemic diseases which may affect assessment or follow-up such as terminal cancer, renal failure (creatinine>200umol/L if known), cirrhosis, severe dementia or psychosis.
• Subject has participated in another clinical trial within the last three months

The Study Endpoints are:

• Primary Efficacy Outcomes is the modified Rankin Scale grades at 3 months for all randomized subjects.
• Secondary Efficacy Outcomes are standard Western scales such as for stroke: NIHSS, mRS, Barthel index, mini-mental State Examination (MMSE).

Eligibility criteria have been chosen to allow most of the ischemic stroke patients to be included in the study and benefit from the TCM treatment.

Patient participation to the study will consist of a simple procedure:

• Recruitment: The investigator in charge of the trial determines whether the patient fits the criteria of inclusion and exclusion. Once eligibility is confirmed, the patient is offered to participate to the trial and is asked to sign a consent form.
• Assignment: The patient eligible is randomly assigned either to NeuroAiD or to a matched-placebo for 3 months.
• Initial assessment: On the first day of treatment, the doctors assess the patient neurological disability on 3 stroke standard scales used in western clinical trial methodology: NIHSS (neurological deficits), mRS (functional outcome) and MMSE (cognitive functions).
• Assessment at discharge from the hospital: When the patient leaves the hospital, the doctor will conduct a similar examination to assess the patient improvement.
• Assessment at 1 month: This assessment is performed by phone and assesses only patient autonomy (mRS).
• Assessment at 3 months: the patient recovery is assessed by investigators on the same three standards scales. Patient independence from any help, physical or verbal will also be measured by a fourth test called Barthel Index.
• As per standard clinical trial guidelines, the CHIMES Society has appointed a Data and Safety Monitoring Board that will provide an unbiased process through which the CHIMES study will be monitored and patient safety protected.