Study of Descartes-08 compared to placebo in adults with generalized myasthenia gravis
Not recruitingStudy of Descartes-08 compared to placebo in adults with generalized myasthenia gravis
- Participants:Adults
Rare diseases
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DESCARTES-08 is an investigational substance being studied in a Phase 3 clinical trial for generalized myasthenia gravis, a chronic autoimmune disease in which the immune system attacks the connection between nerves and muscles, leading to weakness and fatigue.[1] It is not yet described as an authorised medicine in the available trial record.
The available trial record does not describe the mechanism of action of DESCARTES-08 in detail. The trial is designed to evaluate its effect on symptoms of generalized myasthenia gravis, measured by the Myasthenia Gravis Activities of Daily Living (MG-ADL) score, which reflects how well a person can carry out everyday activities affected by muscle weakness.[1]
DESCARTES-08 is given by intravenous use, meaning it is administered directly into a vein.[1] The trial record lists the intervention as a drug for intravenous use.
One clinical trial of DESCARTES-08 is authorised. It is a Phase 3, randomised, double-blind, placebo-controlled study in patients with generalized myasthenia gravis.[1] The trial plans to enroll 119 participants.[1]
The primary outcome measure is the proportion of participants who have a decrease of at least 3 points in MG-ADL score at Month 4 compared to Baseline, in the active group versus the placebo group.[1] The MG-ADL scale assesses the impact of myasthenia gravis on daily activities such as speaking, chewing, swallowing, and breathing.
The authorised trial is for patients with generalized myasthenia gravis. The trial record does not list further eligibility criteria such as age range or prior treatments.[1]
The available sources do not provide information on side effects of DESCARTES-08.
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