The NeuroAiD™ clinical trials were conducted as phase II and phase III clinical trials on more than 605 patients. They are published in Stroke journal, January 2009: Read the abstract on PubMed

All patients selected had an ischemic stroke in the last six months. The patients were divided into two groups:
- The Trial Group, composed of patients who took NeuroAiD™.
- The Control Group, composed of patients who took the standard treatment used commonly for stroke recovery.

The trial lasted for one month, and was intended to assess NeuroAiD™ effects on reducing post stroke disabilities and regaining independence.

Clinical trials showed NeuroAiD helps:

Reaching Independence

Independence for a stroke victim is the ability to walk, think and live decently after his recovery.

Patients treated with NeuroAiD™ within 6 months after their stroke occurrence have 2.4 times more chances to recover independence.

14.1% of the patients taking NeuroAiD™ recovered their abilities compared to only 5.9% of patients in the control group (i.e. who were not treated with NeuroAiD).

In simple numbers it would be:
- Out of 1,000 patients treated with NeuroAiD™, 141 recovered their independence.
- Out of 1,000 patients not receiving NeuroAiD™, only 59 recovered their independence.

i.e. Patients treated with NeuroAiD™ had more than doubled (x2.4 times) their chances to recover independence, be able to take care of themselves and speak freely.

Reducing Disabilities

Stroke patients usually suffer mental or physical disabilities which vary depending on stroke location and severity.

Most common disabilities resulting from stroke are: paralysis or hemiplegia, language impairments, visual disorders, sensory loss, memory loss or even emotional disturbances.

Patients treated with NeuroAiD regained on average a further 25% of their motor functions.

The clinical trial also looked in detail at the recovery for each type of disability: arm, finger, toe, leg paralysis.

The disability is assessed on a 0 to 5 scale (5 points is a maximum disability like complete arm paralysis, whereas 0 means no disability at all). The difference between both assessments is displayed in the chart, the higher the difference, the bigger the recovery is.

What is a clinical trial?

A clinical trial is a study designed to test the safety and / or effectiveness of a drug in humans. Clinical trials can be divided into four categories or "phases":

Phase I
In Phase I, the experimental drug is tested for the first time in a small group of people (20-80) to evaluate its safety, a safe dosage range and identify side effects. This usually involves healthy volunteers except in certain circumstances where real patients are included, for example patients with terminal diseases in lack of treatment options.

Phase II
In phase II trials, the study drug is given to a larger group of people (100-300) to evaluate its effectiveness and collect more safety information. These studies are closely monitored and involve control groups.

Phase III
Phase III trials are usually done in large groups of people (1000-3000) to confirm its effectiveness, monitor its side effects, compare it to the standard medication used commonly and collect information that will allow the new study drug to be used safely.

Phase IV
Phase IV studies are post-marketing studies to further define the drug’s risks, benefits and optimal use. These studies are designed to detect any rare or long-term adverse effects over a much larger patient population and longer period than was possible during Phase I-III.

Case Reports

In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. A case series (also known as a clinical series) is a medical research study that tracks patients with a known exposure given similar treatment] or examines their medical records for exposure and outcome. Case series may be confounded by selection bias, which limits statements on the causality of correlations observed.

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