Approval Probability
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Adjusted LOA
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Epidiolex · 2 trials · 2 indications
Assess the reduction in spike wave index by evaluating the differences in activity from the four 24-hour ambulatory EEGs each participant obtains while enrolled in this study
| Arm | Type | Description |
|---|---|---|
| Presymptomatic Epidiolex Treatment | EXPERIMENTAL | Epidiolex will be started at 2.5 mg/kg/day divided twice daily. The dose will increase weekly as tolerated over the next 5 weeks to a target dose of 20 mg/kg/day. |
| IP | ACTIVE_COMPARATOR | Epidiolex (Cannabidiol) is a colorless to yellow solution in a 100mL vial that is to be administered with a 5mL syringe.The starting dosage is 2.5 mg/kg twice daily, or 5 mg/kg/day. After one week, the dosage can be increased to a maintenance dosage of 5mg/kg twice daily, or 10 mg/kg/day. Patients who are tolerating Epidiolex at 10mg/kg per day and require further reduction of seizures may benefit from a dosage increase up to a maximum recommended maintenance. Dosage of 10mg/kg twice daily (20mg/kg/day), in weekly increments of 2.5 mg/kg twice daily(5mg/kg/day), as tolerated. For patients in whom a more rapid titration from 10 mg/kg/day to 20 mg/kg/day is warranted, the dosage may be increased to no more frequently than every other day administration of the 20 mg/kg/day. Dosage resulted in somewhat greater reductions in seizure rates than the recommended maintenance dosage of 10 mg/kg/day, but with an increase in adverse reactions. |
| Placebo | PLACEBO_COMPARATOR | Placebo is a colorless to yellow solution in a 100mL vial that is to be administered with a 5mL syringe. The starting dosage is 2.5 mg/kg twice daily, or 5 mg/kg/day. After one week, the dosage can be increased to a maintenance dosage of 5mg/kg twice daily, or 10 mg/kg/day. Patients who are tolerating Placebo at 10mg/kg per day and require further reduction of seizures may benefit from a dosage increase up to a maximum recommended maintenance. Dosage of 10mg/kg twice daily (20mg/kg/day), in weekly increments of 2.5 mg/kg twice daily(5mg/kg/day), as tolerated. For patients in whom a more rapid titration from 10 mg/kg/day to 20 mg/kg/day is warranted, the dosage may be increased to no more frequently than every other day administration of the 20 mg/kg/day. Dosage resulted in somewhat greater reductions in seizure rates than the recommended maintenance dosage of 10 mg/kg/day, but with an increase in adverse reactions. |
| Name | Type | Description |
|---|---|---|
| Epidiolex 100 mg/mL Oral Solution | DRUG | Epidiolex is a prescription form of cannabidiol used to treat seizures. Epidiolex will be started at 2.5 mg/kg/day divided twice daily. The dose will increase weekly as tolerated over the next 5 weeks to a target dose of 20 mg/kg/day. |
| Placebo | OTHER | Placebo is composed of dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose. |
Inclusion Criteria: * Clinical diagnosis of Sturge-Weber Syndrome. * Age 1 to 18 months of age, inclusive. * Neuroimaging demonstrating involvement of 3 or more lobes, or bilateral involvement. * No history of seizures. * Patient's parent or legal guardian provides written informed consent prior to...
Epidiolex/mL is an investigational oral solution being studied for Sturge-Weber Syndrome (SWS) and Electrical Status Epilepticus of Slow-Wave Sleep (ESES). It is a small molecule developed by Jazz Pharmaceuticals plc (JAZZ). The drug is currently in Phase 1 and Phase 2 clinical trials for these conditions.
Epidiolex/mL is a small molecule drug. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated for its efficacy in treating Electrical Status Epilepticus of Slow-Wave Sleep and Sturge-Weber Syndrome, both of which involve neurological abnormalities.
Epidiolex/mL is developed by Jazz Pharmaceuticals plc, which trades under the ticker JAZZ. The company is conducting clinical trials for the drug in the United States, including a completed Phase 1 study and a planned Phase 2 study for Sturge-Weber Syndrome.
Epidiolex/mL is in early clinical development. A Phase 1 trial for Electrical Status Epilepticus of Slow-Wave Sleep has been completed, and a Phase 2 trial for Sturge-Weber Syndrome is not yet recruiting. The drug is investigational and not approved for any use.
Epidiolex/mL has two registered trials. NCT04721691 is a completed Phase 1 study in Electrical Status Epilepticus of Slow-Wave Sleep with 16 participants. NCT07778810 is a Phase 2 trial for presymptomatic Sturge-Weber Syndrome, not yet recruiting, with a planned enrollment of 10.
Yes, Epidiolex/mL is also known as Epidiolex 100 mg/mL Oral Solution. This alternative name reflects the drug's formulation as an oral solution at a concentration of 100 mg/mL. Both names refer to the same investigational drug product developed by Jazz Pharmaceuticals.