Product
ganaxolone
Name
ZTALMY
INN Name
ganaxolone
FDA Approved
Yes
4 clinical trials
1 organization
4 indications
1 document
Indication
Drug-resistant Partial Onset SeizureIndication
CDD - CDKL5 Deficiency DisorderIndication
EpilepsyIndication
PartialClinical trial
A Multicenter, Double Blind, Randomized, Placebo-Controlled Trial to Determine the Efficacy and Safety of Ganaxolone as Adjunctive Therapy for Adults With Drug-Resistant Partial-Onset Seizures Followed by Long-term Open-Label TreatmentStatus: Completed, Estimated PCD: 2016-05-01
Clinical trial
A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Children and Young Adults With Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD) Followed by Long-term Open-label TreatmentStatus: Completed, Estimated PCD: 2020-07-31
Clinical trial
A follow-on, Two-year Open-label Extension Study of Ganaxolone as add-on Therapy in Adult Patients With Drug-resistant Partial-onset SeizuresStatus: Terminated, Estimated PCD: 2016-12-01
Clinical trial
An Open-label Extension Study to Evaluate the Safety, Tolerability, and Efficacy of Ganaxolone as add-on Therapy in Adult Patients With Epilepsy Consisting of Uncontrolled Partial-onset Seizures.Status: Completed, Estimated PCD: 2009-12-01
Document
DailyMed Label: ZTALMYOrganization
Marinus Pharmaceuticals, Inc.