Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease or motor neuron disease (MND), is a fatal disease of the nervous system, characterized by progressive muscle weakness resulting in paralysis. Symptoms include stiff muscles, muscle twitching, and gradually worsening weakness due to muscles decreasing in size.
In ALS, moton neurons controlling the voluntary muscles, start to gradually degenerate and die. With muscles not receiving the nerve impulses, shrink and waste away.
Clinical Trials On ALS
In total, A total of 708 studies have been registered around the world, where the major studies were from North America (373), Europe (225), East Asia (64), and Pacifica (24).
Currently, a total of 180 ongoing studies on ALS are recorded on Clinicaltrials.gov, where the major studies are going in North America (94), Europe (64), East Asia (20), and Pacifica (12).
Data as in Sep 2020
- In August 2016, Agency for Toxic Substances and Disease Registry (ATSDR) released its second prevalence report, which indicated an estimated 16,000 persons (5.0 per 100,000 population) were living with ALS in 2013.
- Approximately 5600 people in the United States are diagnosed with ALS each year.
- The annual incidence is 2-3 per 100,000 population; this is about equal to that of multiple sclerosis and 5 times higher than that of Huntington disease.
- The lifetime risk for developing ALS for individuals aged 18 years has been estimated to be 1 in 350 for men and 1 in 420 for women. These estimates are close to those reported from 4 European registries, using different methods.
- ALS remains more common among whites, males, non-Hispanics, and persons aged 60–69 years.
- The ratio of affected males to affected females may approach 2:1.
- A study estimates that the number of ALS cases will increase substantially in the developing world over the next 25 years.
- Notably, developing countries (China, Iran, Libya, Serbia, Taiwan, and Uruguay) will see a 50% increase in the number of ALS cases from 2015 to 2040.
- It also estimates the number of cases of ALS in the world will increase from 222,801 in 2015 to 376,674 in 2040, representing an increase of 69%. The largest increase will be seen in Africa with 116%, followed by Asia with 81% and South America with 73%.
Recruitment in ALS Clinical Trials
With such prevalence reported worldwide, generally, a rate of recruitment of about 2-3 patients per site per month is considered to be good recruitment to plan study at that site.
However, in a recently performed clinical trial feasibility on Credevo, sites with potentially high recruitment rates were found. Some of these sites reported a prospective recruitment rate as high as 15 patients per month.
Clinical Trial Feasibility That Found High Recruitment Sites For ALS Trials
This clinical trial was a Phase III study in Amyotrophic Lateral Sclerosis (ALS). It was designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial.
The target patient population included both males and females patients within 18 to 81 years age-group, diagnosed with laboratory supported, clinically “probable” or “definite” ALS according to the World Federation of Neurology revised El Escorial criteria (Brooks, 1994) with disease duration (from symptoms onset) no longer than 36 months at the screening visit.
The feasibility of this well-designed clinical trial was explored in Canadian sites. The choice of Canada as the clinical trial destination was well supported by the excellent regulatory environment and availability of great quality investigators in Canada. (Click here for details about Canadian Clinical Trial Regulatory Process)
Here are the salient points from the feasibility results obtained.
1. Number of responses received were 100% of required site number.
2. More than half of the sites reported a prospective recruitment rate of 4 patients/month or more.
3. More than a quarter of sites reported a prospective recruitment rate of 10 patients/month or more.
4. Highest prospective recruitment rate reported was 15 patients/month.
5. Responding sites included more of public than private institutes.
6. Average prospective recruitment rate reported was 5.5 patients per site per month.
7. This average rate reported was more than the expected range of 2-5 patients per site per month.
How To Contact These High Recruiting Sites And Investigators?
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