Clinical trials located in

Newcastle-Upon-Tyne

Newcastle-Upon-Tyne city is located in United Kingdom. Currently, 1 clinical trials are being conducted in this city.

  • CT-EU-00112545

    Evaluating the Safety and Effectiveness of DYNE-101 for Myotonic Dystrophy Type 1 Patients

    This clinical trial is focused on evaluating a new treatment called DYNE-101 for individuals with Myotonic Dystrophy Type 1 (DM1). The main goal is to see how safe and tolerable this treatment is when given through an intravenous (IV) infusion, which means directly into the vein. The study is designed to carefully monitor how participants respond to multiple doses of DYNE-101 over time.

    The trial is structured into four main phases. It starts with a Screening Period that lasts up to 8 weeks to determine eligibility. Following this, there is a multiple-ascending dose (MAD) Placebo-Controlled Period that goes on for 24 weeks, where the safety and effectiveness of different doses of DYNE-101 are compared against a placebo (a treatment with no active drug). This is to ensure that any changes in participants’ health can be accurately attributed to the treatment. After this phase, there is a Treatment Period of another 24 weeks, where all participants receive DYNE-101. The study concludes with a Long-Term Extension (LTE) Period lasting 96 weeks, aimed at understanding the long-term impacts of the treatment.

    One of the key aspects being monitored throughout the study, up to Week 145, is the number of participants who experience any treatment-emergent adverse events (TEAEs), which are any new or worsening health issues that occur during the trial.

    This study represents an important step towards finding a new treatment option for those living with Myotonic Dystrophy Type 1, with a strong focus on safety and the overall well-being of the participants.

    • DYNE-101

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