Condition: Generalized Myasthenia Gravis · Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
The purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in comparison to placebo. It will also investigate the sustained efficacy, the need for retreatment, and the long-term safety of oral cladribine in gMG. An additional component is included to characterize the Pharmacokinetics (PK) of the new cladribine formulation in gMG participants. This study is divided into 3 periods: the double-blind placebo control (DBPC) pivotal period, and 2 extensions, the blinded extension (BE) and the retreatment (RT) period. Furthermore, in trial interviews will be conducted as a sub-study to MyClad with a sub-set of participants to gain an in depth understanding of the participant cladribine treatment and study experience.
This description comes directly from the study's public registry record.
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| Neurology of Central Florida Research Center, LLC | Altamonte Springs, Florida, United States | Recruiting |
| SFM Clinical Research, LLC | Boca Raton, Florida, United States | Recruiting |
| University of Florida Health Science Center - 300120311 | Jacksonville, Florida, United States | Recruiting |
| Neurology Associates, P. A. | Maitland, Florida, United States | Recruiting |
| University of South Florida - PARENT - PARENT | Tampa, Florida, United States | Recruiting |
| University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN) | Kansas City, Kansas, United States | Recruiting |
| UNC Hospitals - PARENT | Chapel Hill, North Carolina, United States | Recruiting |
| Atrium Health Wake Forest Baptist | Winston-Salem, North Carolina, United States | Recruiting |
+ 133 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06463587