Who is sponsoring NCT05864846?

NCT05864846 is sponsored by Jazz Pharmaceuticals.

What drugs are being tested in NCT05864846?

Interventions in NCT05864846: Cannabidiol Oral Solution [Epidiolex].

What condition does NCT05864846 study?

NCT05864846 studies Tuberous Sclerosis Complex Associated Neuropsychiatric Disease.

Is NCT05864846 still recruiting?

NCT05864846 is currently active, enrolled. Last updated 12 March 2026.

Last reviewed 2026-03-12 · How we verify

NCT05864846: EpiCom

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex

Active, enrolled Phase 4 Last updated 12 March 2026

What this trial tests

Phase 4 trial testing Cannabidiol Oral Solution [Epidiolex] in Tuberous Sclerosis Complex Associated Neuropsychiatric Disease in 79 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

29 June 2023

Primary endpoint
26 March 2026

26 March 2026

Quick facts

Lead sponsor	Jazz Pharmaceuticals
Phase	Phase 4
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	79
Start date	29 June 2023
Primary completion	26 March 2026
Estimated completion	26 March 2026
Sites	19 locations across United Kingdom, Canada, United States, Poland

Drugs / interventions tested

Cannabidiol Oral Solution [Epidiolex] — full drug profile →

Conditions studied

Tuberous Sclerosis Complex Associated Neuropsychiatric Disease — all drugs for Tuberous Sclerosis Complex Associated Neuropsychiatric Disease →

Sponsor

Jazz Pharmaceuticals — full company profile →

Who can join

Adults 1 to 65, any sex, with Tuberous Sclerosis Complex Associated Neuropsychiatric Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

FAAH Modulators from Natural Sources: A Collection of New Potential Drugs.
Nicoara C, Fezza F, Maccarrone M. · · 2025 · cited 4× · PMID 40214504 · DOI 10.3390/cells14070551
Protocol for EpiCom: A phase 3b/4 study of behavioral outcomes following adjunctive cannabidiol for the management of tuberous sclerosis complex-associated neuropsychiatric disorders (TAND).
van Eeghen AM, Thiele EA, Amin S, Samanta D, et al · · 2025 · cited 1× · PMID 40504787 · DOI 10.1371/journal.pone.0324648

Verify or expand the search:

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05864846 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 12 March 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/NCT05864846.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing