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NCT05485831: EpiTALY
Observational, Prospective, Multicenter Study of Epidyolex® (Cannabidiol CBD 100 mg/ml) Oral Solution, as Adjunctive Treatment for Seizures Associated With Lennox- Gastaut Syndrome (LGS), Dravet Syndrome (DS) and Tuberous Sclerosis Complex (TSC)
trial testing Epidiolex 100 mg/mL Oral Solution in Lennox Gastaut Syndrome in 111 participants. Participants enrolled and being followed up; not accepting new ones.
1 February 2027
Quick facts
| Lead sponsor | Jazz Pharmaceuticals |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 111 |
| Start date | 24 February 2025 |
| Primary completion | 1 February 2027 |
| Estimated completion | 1 February 2027 |
| Sites | 18 locations across Italy |
Drugs / interventions tested
- Epidiolex 100 mg/mL Oral Solution — full drug profile →
Conditions studied
- Lennox Gastaut Syndrome — all drugs for Lennox Gastaut Syndrome →
- Dravet Syndrome — all drugs for Dravet Syndrome →
- Tuberous Sclerosis Complex — all drugs for Tuberous Sclerosis Complex →
Sponsor
Jazz Pharmaceuticals — full company profile →
Who can join
2 and older, any sex, with Lennox Gastaut Syndrome or Dravet Syndrome. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Participants Remaining on Therapy from Enrollment
Time frame: Baseline up to Week 52 post-dose.
Treatment retention will be evaluated through the proportion of participants remaining on therapy from the enrollment visit (baseline, V0) to each study visit (Weeks 4 \[V1\], 16 \[V2\], 28 \[V3\], 40 \[V4\], 52 \[V5\]).
Sponsor's own description
This is a prospective, observational study on approximately 70-100 Real World participants affected by LGS, DS, or TSC treated with Epidyolex® as prescribed in the summary of product characteristics. The eligible participants are expected to participate in the study for a duration of 52 weeks of treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05485831
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Epidiolex 100 mg/mL Oral Solution
Trials testing the same drug.
- NCT04721691 — Efficacy of Epidiolex in Patients With Electrical Status Epilepticus of Sleep (ESES). · Phase 1 · completed
- NCT04642404 — CBD for Dental Pain · Phase 1, PHASE2 · completed
Other recruiting trials for Lennox Gastaut Syndrome
Currently open trials in the same condition.
- NCT05066217 — An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome · Phase 3 · recruiting
- NCT06401538 — BMB-101 in Absence Epilepsy and DEE · Phase 2 · recruiting
- NCT06464653 — Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome · NA · active not recruiting
- NCT05339126 — RNS System LGS Feasibility Study · Phase 2 · active not recruiting
- NCT05374824 — Comparative Effectiveness of Palliative Surgery Versus Additional Anti-Seizure Medications for Lennox-Gastaut Syndrome · recruiting
Other Jazz Pharmaceuticals trials
Trials by the same sponsor.
- NCT07533942 — A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma · Phase 2 · not yet recruiting
- NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC · Phase 2 · not yet recruiting
- NCT07377539 — A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants · Phase 1 · not yet recruiting
- NCT07282587 — Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma · Phase 2 · recruiting
- NCT07233239 — A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05485831 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jazz Pharmaceuticals
- Last refreshed: 1 June 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05485831.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing