Company Plans Extension Study for Phase 3 Trial of Amyotrophic Lateral Sclerosis Drug

According to a story from pm360online.com, the Orion Corporation, a pharmaceutical company based in Finland, has recently announced that it plans to continue its Phase 3 trial of levosimendan as a treatment for amyotrophic lateral sclerosis into an open label extension study. This clinical trial is expected to complete enrollment by the summer of 2019.

About Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis, otherwise known as Lou Gehrig’s disease, is a rare, degenerative disease that causes the death of nerve cells associated with the voluntary muscles. Little is known about the origins of amyotrophic lateral sclerosis, with no definitive cause in about 95 percent of cases. The remaining five percent appear to inherit the disease from their parents. Symptoms initially include loss of coordination, muscle weakness and atrophy, muscle stiffness and cramping, and trouble speaking, breathing, or swallowing. These symptoms worsen steadily over time; most patients die because of respiratory complications. Treatment is mostly symptomatic and the medication riluzole can prolong life. Life expectancy after diagnosis ranges from two to four years, but some patients can survive for substantially longer. To learn more about amyotrophic lateral sclerosis, click here.

About The Clinical Trial

This clinical trial will test levosimendan’s ability to improve the function of the respiratory muscles in patients with amyotrophic lateral sclerosis. Failure of the respiratory muscles is often one of the final stages of disease progression before the death of the patient. Delaying or reversing the degeneration of the breathing muscles would be a major improvement in treatment for amyotrophic lateral sclerosis patients. This clinical trial is projected to involve around 450 patients and a total of 105 test sites in the US, EU, Australia, and Canada. The original trial period is expected to last one year.

The purpose of the open label extension is to establish long term data on safety and efficacy; it will also allow patients who see benefit from the treatment to continue use as long as is necessary.

About Levosimendan

Levosimendan was originally developed as a treatment for acute decompensated heart failure and first entered public use in 2000. Hopefully this trial will add a new indication for this drug and provide amyotrophic lateral sclerosis patients with a new and more effective option for treatment.

 


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