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CBD-OS · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| CBD-OS | EXPERIMENTAL | Participants with DEE will be randomized to CBD-OS up to 10 mg/kg twice daily for a 6-week treatment period. |
| Placebo | PLACEBO_COMPARATOR | Participants with DEE will be randomized to matching placebo for a 6-week treatment period. |
| Open-Label Extension: CBD-OS | EXPERIMENTAL | Participants with DEE who completed the double-blind phase of the study and enter the optional OLE will begin a 22-week open-label treatment period with CBD-OS up to 10 mg/kg twice daily following a 2-week Blinded Transition Period. |
| Name | Type | Description |
|---|---|---|
| CBD-OS | DRUG | Oral solution, twice daily |
| Placebo | DRUG | Oral solution, twice daily |
Participants are eligible to be included in the study only if all the following criteria apply: 1. Is at least 1 year of age at the time of signing the informed consent/assent. 2. Meets the clinical phenotype for DEE as specified in the protocol. 3. Per the investigator, the underlying etiology con...
CBD-OS is an investigational small molecule being developed by Jazz Pharmaceuticals for the treatment of focal seizures and developmental and epileptic encephalopathy (DEE). It is a cannabidiol oral solution being studied in clinical trials for these epilepsy-related conditions.
CBD-OS is a pharmaceutical formulation of cannabidiol, a cannabinoid compound. While its exact molecular target is not specified, it is being studied for its antiseizure effects in patients with focal seizures and developmental and epileptic encephalopathy.
CBD-OS is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company listed on the NASDAQ under the ticker symbol JAZZ. The company is conducting clinical trials to evaluate the efficacy and safety of this oral solution for seizure disorders.
CBD-OS is currently in Phase 3 clinical development. One Phase 3 trial is recruiting participants with focal seizures, and another Phase 3 trial is not yet recruiting for developmental and epileptic encephalopathy. It remains investigational and is not yet approved by regulatory authorities.
CBD-OS is being studied in two clinical trials. NCT07233239 is a Phase 1 study evaluating efficacy and safety in focal-onset seizures, with 100 participants in the United States. NCT07723976 is a Phase 3 study in developmental and epileptic encephalopathy, with 120 participants.
Yes, CBD-OS is also known as GWP42003-P and JZP926. These names refer to the same investigational cannabidiol oral solution being developed by Jazz Pharmaceuticals for the treatment of seizure disorders.