A PHASE 1B, MULTICENTER, RANDOMIZED, PLACEBO- CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND BIOLOGICAL ACTIVITY OF TQS-168 IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS
This research study is looking into a new potential treatment called TQS-168 for people who have Motor Neurone Disease (MND), also known as Amyotrophic Lateral Sclerosis (ALS). It's an early-stage study, meaning it’s one of the first times this medicine is being tested in humans. The main goals are to check if TQS-168 is safe to use and how well people tolerate it. Researchers will also be looking for early signs that the medicine might have a positive effect on the condition. To make sure the results are reliable, some people will receive the new medicine and others will receive a dummy pill (placebo), but neither the patients nor the doctors will know who is getting what. This helps to get unbiased results about the medicine's effects.
At a glance
What is this study about?
This study is exploring a new medicine called TQS-168 for people living with Motor Neurone Disease (MND), which is also known as Amyotrophic Lateral Sclerosis (ALS).
When a new medicine is developed, it goes through different stages of testing. This particular study is in an early stage, which means it's one of the first times researchers are giving TQS-168 to human volunteers. The main aims at this point are to find out if the medicine is safe, what dose can be given without causing serious side effects, and how the body handles the medicine. Researchers will also be keeping a close eye to see if there are any early indications that TQS-168 might be helping with MND/ALS.
To make the study as fair and accurate as possible, it's set up in a special way. Some people will receive the actual medicine, TQS-168, while others will receive a placebo – which looks exactly like the medicine but contains no active ingredients. This helps researchers compare the effects of the real medicine against doing nothing special. Neither the patients nor the doctors involved will know who is receiving which, to prevent any bias in the results. This is called a 'double-blind' study.
Key takeaways
- This study is testing a new medicine (TQS-168) for MND/ALS.
- It's an early-stage study to check for safety and how the body handles the medicine.
- Some people will get the medicine, others a dummy pill (placebo), and no one will know which.
- Participation involves regular clinic visits for health checks and tests.
- It's open to adults aged 18 and over, with no upper age limit.
- You can stop participating at any time if you change your mind.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. There is no upper age limit set, so people of all adult ages and backgrounds are welcome to be considered.
This study is specifically for people who have been diagnosed with Motor Neurone Disease (MND), also known as Amyotrophic Lateral Sclerosis (ALS). It's important that your diagnosis is confirmed for you to be eligible.
Both men and women can take part in this research. Beyond these general points, there will be more detailed health checks and requirements that the study team will discuss with you to make sure the study is a good fit for your individual situation.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with Motor Neurone Disease (MND) / Amyotrophic Lateral Sclerosis (ALS)?
- Are you able to attend regular clinic appointments as required by the study?
- Are you willing to potentially receive either the new medicine or a dummy pill (placebo)?
What does participation involve?
If you decide to take part, you will be part of a group that receives either the new medicine (TQS-168) or a dummy pill (placebo) for a set period. You won't know which one you are getting, and neither will your study doctor.
The study will involve several visits to the clinic. These visits will allow the research team to monitor your health closely, perform examinations, and collect samples (like blood or urine) to see how you are responding to the treatment. You will also be asked questions about how you are feeling and any changes you notice.
Each visit will likely include assessments to track your MND/ALS symptoms. There will also be follow-up appointments after you finish taking the study medicine to ensure your well-being. The exact number of visits and the total duration of your participation will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is Motor Neurone Disease (MND) or ALS?
MND/ALS is a condition that affects the nerves in the brain and spinal cord, which gradually stops the muscles from working.
What does 'early-stage study' mean?
It means this is one of the first times this new medicine is being tested in people. The main goals are to check if it's safe and how the body copes with it.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active ingredients. It helps researchers compare the actual drug's effects.
Will I know if I'm getting the real medicine?
No, neither you nor your doctor will know if you're receiving the new medicine or the placebo. This is to ensure the study results are as fair and accurate as possible.
Can I stop participating if I want to?
Yes, you are free to stop participating in the study at any time, for any reason. Your decision will not affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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