Here are some of the details
In total, 470 patients with ALS will be included in the trial in 5 different countries (France, Germany, the United Kingdom, Belgium and Spain).
Benefit of the trial
You were invited to participate in this trial because you have been diagnosed with ALS. It is possible that you may benefit from this new drug because presumably (as was demonstrated in animal experiments) it can exert protective and regenerative (restoring) effects on the nerve cells and so contribute to reducing your discomfort and symptoms, and slowing disease progression. In the case of your random assignment to the group of patients receiving placebo-capsules (without active substance) you will not have the potential benefits of this new medication. You may decide to withdraw from this trial at any time, without giving a reason, and without penalty or loss of any rights or benefits to which you are otherwise entitled. In addition, as part of your participation in the trial your health will be closely monitored. Your participation in the study may help patients in the future by giving important information about TRO19622 and the treatment of ALS.
Currently, the only medicine shown to be beneficial in MND is the medicine called riluzole, which you’re already taking. This alters the rate at which MND progresses and in a study of people with MND treated with riluzole or placebo over a period of 18 months, those taking riluzole survived on average 3 months longer than those on placebo.