PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS

This study is looking for men and women with a confirmed diagnosis of ALS, aged between 18 and 75 years old. To be considered, you should have been diagnosed with ALS fairly recently (within the last two years) and your symptoms should be mild to moderate, rather than very severe.

You also need to be able to use an inhaler to take the study medication and be well enough to attend all appointments. Crucially, you must already be taking Riluzole, a standard ALS medication, and have been on a stable dose for at least four weeks before joining the study.

For women who could become pregnant, it's important to agree to use effective contraception during the study and for three months afterwards. Your doctor will carefully check all these requirements to see if this study could be a good fit for you.

If you decide to take part, you'll be in the study for about 24 weeks, which is roughly six months. During this time, you'll receive the study medication through a dry powder inhaler, either PHENOGENE-1A (at a low or high dose), or a dummy treatment (placebo). You will take this twice a day. You'll also continue to take your usual Riluzole medication as prescribed by your doctor.

The study involves regular visits to the clinic where you'll have various checks and tests. These will include assessing your ability to do daily tasks using a special rating scale, checking your lung function with breathing tests (like forced vital capacity), and having blood tests to look for signs of inflammation. These assessments help the researchers understand how the treatment is working. It's important to attend all your scheduled appointments so the researchers can gather all the necessary information.