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What are clinical trials?
Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce the best data available for health care decisionmaking.
The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help produce reliable study results.
Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ideas.
If an approach seems promising, the next step may involve animal testing. This shows how the approach affects a living body and whether it’s harmful. However, an approach that works well in the lab or animals doesn’t always work well in people. Thus, research in humans is needed.
For safety purposes, clinical trials start with small groups of patients to find out whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about the new approach’s risks and benefits.
A clinical trial may find that a new strategy, treatment, or device:
- Improves patient outcomes
- Offers no benefit
- Causes unexpected harm
All of these results are important because they advance medical knowledge and help improve patient care.
What is Radicut?
Radicut (Edaravone) is a drug tested for ALS by the Japanese pharmaceutical company Mitsubishi Tanabe. This company claims positive results of Radicut in ALS, based on which Radicut has been approved for use in ALS in Japan. However, this study included a limited number of patients and had a relatively short time frame of 24 weeks. Moreover, Mitsubishi Tanabe has not published its research yet in a peer-reviewed* scientific journal. This makes it very difficult to assess its claims about Radicut. If Radicut could indeed slow down the progression of ALS this would be promising for further studies, but until results are published the effectiveness of Radicut in ALS remains unclear.
Radicut is not approved for use in ALS in any other country than Japan at this time. In the study with Radicut, ALS patients received 60mg of the compound via intravenous injection daily for two weeks followed by two weeks off. Treeway, a Dutch biotechnology company, has announced that it will reformulate Radicut into an oral medication for further exploration and rigorous testing in ALS patients.
*A peer-reviewed journal is one where published work has been evaluated by respected researchers qualified to comment on the subject matter. As a result, peer-reviewed journals are held in greater respect. Generally scientists would only be confident in work that was published in a journal of this type.
What is GM604?
GM604 is an experimental drug of the pharmaceutical company Genervon. GM604 is under investigation as a treatment for motor neurone disease / ALS.
Genervon has published a press release about “very promising results” from a clinical trial with GM604 conducted to date on 12 people over a 12-week period.
Understandably this has generated hope among people living with MND around the world.
However, this study is very small and most results from earlier small scale studies have unfortunately not been reproduced in larger studies. Therefore, neurologists and scientists are cautious about results from small, short-term studies, such as tests on GM604 to date. A larger phase 3 trial of GM604 is needed. TRICALS would like to invite Genervon to conduct this trial with European ALS Centres connected to TRICALS.
More information about GM604 can be found on the website of the MND Association, the British patient organisation for ALS/MND and in the blog about GM604 from the research director of the MND Association.
Which ALS Centres are connected to TRICALS?
Several European ALS Centres are already connected to TRICALS. Please see ALS Centres in the main menu on the home page.
TRICALS is currently located at the ALS Centre Netherlands, located in the University Medical Center (UMC) Utrecht, in the Netherlands.
The ALS Centre Netherlands works closely with several ALS centers throughout Europe (ENCALS) and the rest of the world. The goal of ENCALS is to find an effective treatment for ALS by working together as European ALS Centres and researchers. Professor L.H. van den Berg (bio), coordinator of the ALS Centre Netherlands, is currently the chair of ENCALS.