The neuromuscular junction (NMJ) is the site where motor neurons connect to muscle fibers, allowing signals from the brain to pass to muscles. Glial cells, which support neurons, play a crucial role in maintaining the stability and repair of this junction. Many researchers believe that one of the earliest events in ALS is the disconnection of motor neurons from muscles at the NMJ, along with inadequate glial cell repair. This Phase 2 trial will investigate the effects of the drug darifenacin on the NMJs of people living with ALS. The hypothesis is that darifenacin can help maintain this essential connection between neurons and muscles by targeting glial cell repair, thereby improving muscle control and function while reducing muscle loss. The study will recruit 30 participants, who will be randomly assigned to receive either the active drug or a placebo orally for 24 weeks. Researchers will monitor participants to ensure the drug’s safety and determine the appropriate dosage. They will also assess muscle strength, respiratory function, and changes in the ALS Functional Rating Scale-Revised (ALSFRS-R) score.
View the ALS Clinical Trials Unboxed webinar on darifenacin here.
The progressive paralysis experienced by people living with ALS can eventually make communicating with others difficult as the ability to gesture and speak lessens with the weakening of the muscles. To help improve quality of life for people affected by ALS, researchers from the Ottawa Hospital Research Institute are testing the safety of a new assistive device that uses brain-computer interface (BCI) technology to help people who have motor impairments to communicate. This device can convert brain signals into single letters on a computer screen, allowing people to spell words simply with their thoughts. The technology requires surgical placement of two sensors into the areas of the brain that support motor and cognitive function. Researchers will be monitoring the two participants to ensure that the procedure is safe, and to assess the ability of this technology to support effective communication and improve quality of life.