Stiris Research Inc. Announces First Patient Enrolled in Phase II-III Congenital Myotonic Dystrophy Trial
Stiris Research (“Stiris”) an entrepreneurial clinical trial management company focused on the management of Phase I-IIIB trials, today announces the first patient enrolled in a Phase II/III open label congenital myotonic dystrophy trial
“We are very pleased to have completed our first Site Initiation Visit (SIV) for this on 03Aug2021. This is an important milestone as the first subject from the randomized, double-blind antecedent study will rollover to the Open-Label Extension study at the end of August. We would like to thank the study team for their collaboration so far on this important study and look forward to initiating further sites in the coming months,” said Madison Pearce, Project Manager
Congenital Myotonic Dystrophy (CMD) is a rare early childhood form of myotonic dystrophy (also known as Steinert’s disease) with symptoms generally beginning to show in childhood or later in life, however symptoms of congenital myotonic dystrophy are evident from birth. CMD is generally characterized by diminished muscle tone (hypotonia), progressive muscle weakness and degeneration (atrophy). CMD only occurs when the mother already has myotonic dystrophy (although she may not be aware of this) and passes it on to her child in a more severe form. Myotonic, meaning “involving muscle stiffness” and Dystrophy, meaning “muscle wasting, and weakness” have a devastating impact on these children. CMD varies considerably in severity, symptoms and progression from child to child, but in some cases can be fatal, especially in the early weeks of life (www.musculardystrophyuk.org) and (https://rarediseases.org/rare-diseases/congenital-muscular-dystrophy).
About Stiris Research
Stiris Research is an entrepreneurial Clinical Trial Management company specializing in conducting complex Phase I through IIIB trials for North American biotechnology and biopharmaceutical companies, with a focus on Oncology, CNS and Neurology. Stiris Research was formed as a result of listening to the stakeholders engaged in clinical trials, identifying their unmet needs, and developing a unique, value-based approach to address those needs.
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