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A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures

StatusRecruiting
PhasePhase 1
Started2025-11-26
View on ClinicalTrials.gov ↗

Amendment history

2026-08-07
minor
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 24 sites
2026-07-30
minor
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 24 sites
2026-06-05
minor
Study Status, Contacts/Locations v10
Study sitesdetails revised at 1 of 24 sites
2026-06-01
minor
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 24 sites
2026-05-01
minor
Study Status, Contacts/Locations v8
Study sites23→24
Show 7 earlier versions
2026-03-31
minor
Study Status, Eligibility, Contacts/Locations v7
Eligibility criteria+133 characters
[...] izure types with typical interictal/ictal EEG findings (eg, history of an EEG with focal sharp waves or slowing). Participants with a documented diagnosis of focal epilepsy and a normal EEG are eligible for inclusion. Participant is currently treated with at least 1, but no mor [...] in for the duration of the study. Presence of only nonmotor onsetfocal aware seizures or primary generalized epilepsies.
Study sitesdetails revised at 4 of 23 sites
2026-03-06
minor
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 23 sites
2026-02-05
minor
Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 23 sites
2025-12-16
minor
Study Status, Contacts/Locations v4
Study sitesdetails revised at 3 of 23 sites
2025-12-05
minor
Study Status, Contacts/Locations v3
Study sitesdetails revised at 1 of 23 sites
2025-12-01
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-12-31→confirmed 2025-11-26
Study sitesdetails revised at 23 of 23 sites
2025-11-20
minor
Study Identification, Study Status, Contacts/Locations v1
Study sites0→23
Study title-34 characters
A Phase 1b, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Cannabidiol Or [...]
2025-11-14
minor
Original filing
723 trials monitored
See 41 trials at risk
Cannabidiol oral solution (CBD-OS) is approved in the US for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or Tuberous sclerosis complex (TSC) in patients 1 year of age and older. This study will assess the efficacy and safety of CBD-OS in participants aged 12 to 75 years for the treatment of focal-onset seizures (FOS).
Trial Details
NCT Number NCT07233239
Lead Sponsor Jazz Pharmaceuticals
Collaborators: Jazz Pharmaceuticals Research UK Ltd.
Conditions Focal Seizures
Enrollment 100 participants
Start Date 2025-11-26
Primary Completion 2027-11-29 (estimated)
Study Completion 2027-11-29 (estimated)
Updated on ClinicalTrials.gov 2026-08-11