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Latest updates to the Cenobamate Open-Label Extension Study Clinical Trial page

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    Summary
    The study has expanded to include 42 locations, and the website has been updated to version 2.10.0, replacing the previous version 2.9.7.
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    Check dated 2024-07-23T14:49:03.000Z thumbnail image
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    The website has been updated to Revision v2.9.7 from v2.9.6.
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    The value of Revision has been updated from v2.9.5 to v2.9.6, indicating a recent revision in the content of the webpage.
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    The value of Revision has been updated from v2.9.3 to v2.9.5, indicating a recent revision in the content of the webpage.
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    The value of Revision has been updated from v2.9.1 to v2.9.3, indicating a recent revision in the content of the webpage.
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    32 days ago
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    Summary
    The value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus related topics: Epilepsy Seizures FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Non-Randomized Interventional Model : Single Group Assignment Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Core Study Placebo Subjects who did not receive Cenobamate in the Core Study will receive Cenobamate 12.5 mg tablet once a day for two weeks, 25 mg tablet once a day for two weeks, 50 mg tablet once a day for two weeks, 100 mg tablets once a day for two weeks, 150 mg tablets once a day for two weeks and 200 mg tablets once a day for twelve weeks. Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight. Drug : Cenobamate active drug Other Names: YKP3089 Experimental : Core Study Active Subjects who received cenobamate in the Core study will continue to receive the same daily dose (150 mg or 200mg). Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight. Drug : Cenobamate active drug Other Names: YKP3089 Primary Outcome Measures Outcome Measure Measure Description Time Frame Incidence of Adverse Events and SAEs Summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination and electrocardiogram (ECG) finding. 386 +/- 2 days Keywords Provided by SK Life Science, Inc. Idiopathic Generalized Epilepsy Additional Relevant MeSH Terms Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Epilepsy Seizures Epilepsy, Generalized Anticonvulsants Cenobamate Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Revision: v2.9.1'. This change represents an update in the information displayed on the webpage regarding the study details, design, interventions, and primary outcome measures.
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    Check dated 2024-06-25T08:42:58.000Z thumbnail image

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