Last reviewed · How we verify
NCT05803434: CBD_RE
Cannabidiol in Children and Young Adults With Rare Disease-associated Severe Epilepsy
Phase 2 trial testing Cannabidiol oral solution in Epilepsy in 30 participants. Status unknown.
1 March 2025
Quick facts
| Lead sponsor | Meyer Children's Hospital IRCCS |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 June 2023 |
| Primary completion | 1 March 2025 |
| Estimated completion | 1 March 2025 |
Drugs / interventions tested
- Cannabidiol oral solution — full drug profile →
Conditions studied
- Epilepsy — all drugs for Epilepsy →
- Rare Diseases — all drugs for Rare Diseases →
Sponsor
Meyer Children's Hospital IRCCS
Who can join
Adults 2 to 25, any sex, with Epilepsy or Rare Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a pilot, open-label, phase II study. The main objective of the study is to demonstrate that Cannabidiol (CBD), used in addition to current anti-seizure medications (ASMs) reduces the number and/or severity of motor (generalized, focal, or both) seizures in children and young adults with rare disease-associated severe epilepsy. Secondary objectives include assessment of safety and tolerability, changes in behaviour, cognition and sleep, pharmacokinetic interaction with concurrent ASMs.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05803434
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cannabidiol oral solution
Trials testing the same drug.
- NCT05885542 — SCORE Emerging Adult Cannabis Use & Stress · Phase 1, PHASE2 · recruiting
- NCT05600114 — Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder · Phase 2 · completed
- NCT05097651 — CBD for Sleep in People With HIV · Phase 2 · withdrawn
- NCT03196934 — Expanded Use of Cannabidiol Oral Solution · no longer available
Other recruiting trials for Epilepsy
Currently open trials in the same condition.
- NCT07095933 — The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy · EARLY_PHASE1 · recruiting
- NCT07224191 — Hippocampal Oscillations During Exploration · NA · recruiting
- NCT07219407 — A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures · Phase 2 · recruiting
- NCT07417280 — LIFUS For Neurological Disorders · NA · recruiting
- NCT07490769 — Levetiracetam Three Times Daily in Epilepsy · Phase 3 · recruiting
Other Meyer Children's Hospital IRCCS trials
Trials by the same sponsor.
- NCT07412782 — REMS25: Study on the Use of REMS Technology in Diseases Commonly Associated With Reduced Bone Mineral Density (BMD) · NA · recruiting
- NCT07363304 — Impact of Elexacaftor-Tezacaftor-Ivacaftor Treatment on Metabolic, Epigenetic and Fecal Microbiota Profiles in People Wi · recruiting
- NCT07412769 — ASMact: Study on Management of Bronchial Asthma · recruiting
- NCT07468461 — CACP: Study on Camptodactyly - Arthropathy - Coxa Vara - Pericarditis (CACP) Syndrome · recruiting
- NCT07348263 — EFESO: Study on Juvenile Onset Eosinophilic Fasciitis · 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 NCT05803434 (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 Meyer Children's Hospital IRCCS
- Last refreshed: 18 April 2023
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/NCT05803434.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing