NeuroAiD™ clinical trials

The NeuroAiD™ clinical trials were conducted as phase II and phase III clinical trials on more than 600 patients. All patients selected had a stroke in the last six months. The patients were divided into two groups:

1. The Trial Group, composed of patients who took NeuroAiD™.
2. 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 measure how NeuroAiD™ can or cannot, help patients to reduce their disabilities and regain independence.

 

Reaching independence

14.1% of the patients taking NeuroAiD™ recovered their independence after one month of treatment compared to only 5.9% of patients in the control group (i.e. who were not treated with NeuroAiD™). Independence is defined as the ability to take care of one’s self and speak freely.

In simple numbers it would be:
Out of 1,000 patients treated with NeuroAiD™, 141 recovered their independence. And out of 1,000 patients, not treated with NeuroAiD™, only 59 recovered their independence. Which means that patients treated with NeuroAiD™, had more than doubled (x2.4 times) their chances to recover independence, being able to take care of themselves and speak freely.

 

Reducing disabilities

Similarly 41.5% of the patients taking NeuroAiD™ recovered more than 55% of their disabilities after one month of treatment compared to only 31.2% of patients in the control group (i.e. who weren’t treated with NeuroAiD™).

In simple numbers it would be:
Out of 1,000 patients treated with NeuroAiD™, 415 reduced significantly their disabilities from stroke (more than 55%). And out of 1,000 patients, not treated with NeuroAiD™, only 312 did recover.

Which means that patients treated with NeuroAiD™, had 33% more chances to reduce significantly their disabilities from stroke.

 

 

More in details

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 before and after the treatment. (5 points is a maximum disability like complete arm paralysis, whereas 0 means no disability at all).

The difference of both assessments is displayed in the chart, the higher the difference, the bigger the recovery is.

 

 

In simple words: Patients treated with NeuroAiD™...
Recovered 27% more of their paralysis in the arms compared to control patients.
Recovered 28% more of their paralysis in the fingers compared to control patients.
Recovered 24% more of their paralysis in the legs compared to control patients.
Recovered 23% more of their paralysis in the toes compared to control patients.

More clinical trials are being performed with NeuroAiD™ and we look forward to share the results with you as soon as we have them.

 

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":

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 end terminal diseases where they lack treatment options.

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 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 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.