Epidiolex (cannabidiol) / Jazz, Nippon Zoki - LARVOL DELTA

Investigating Neuropharmacological Features of the Cortical Activity of Cannabidiol GWP42003 P-A Phase 1 Clinical Trial. (PubMed, Brain Sci) - "Overall, these largely null findings suggest that acute CBD administration lacks a robust, direct modulatory effect on cortical networks. Capturing its precise neuropharmacological mechanisms will likely require future investigations utilizing chronic dosing paradigms or clinical patient populations."

Clinical • Journal • P1 data • CNS Disorders • Epilepsy

Epi-Pre: Epidiolex Trial for Presymptomatic Treatment of Sturge-Weber Syndrome (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Johns Hopkins University | Not yet recruiting ➔ Recruiting

Enrollment open

Combination Use of Acetaminophen and Cannabidiol Leading to Sinusoidal Obstruction-Like Liver Injury (ACG 2026) - "Introduction: A purified pharmaceutical grade cannabidiol (CBD), marketed as Epidiolex is used for patients with Lennox-Gaustaut Syndrome (LGS) and other refractory seizure disorders to decrease seizure frequency...F. Trichrome (5x) pericellular and periportal fibrosis."

Cholestasis • CNS Disorders • Epilepsy • Fibrosis • Hematological Disorders • Hepatology • Immunology • Liver Failure • Primary Immunodeficiency

Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Steven E Harte, PhD | Trial completion date: Oct 2026 ➔ Jun 2027 | Trial primary completion date: Oct 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

CANN-SWITCH: A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex (clinicaltrials.gov) - P4 | N=25 | Not yet recruiting | Sponsor: Elizabeth Donner | Trial primary completion date: Jun 2028 ➔ Jan 2028

Trial primary completion date • CNS Disorders • Epilepsy

Use of Purified Cannabidiol in Treatment-Resistant Pediatric Epilepsy: Beyond Lennox-Gastaut Syndrome, Dravet Syndrome, and Tuberous Sclerosis Complex. (PubMed, Pediatr Neurol) - "Among our cohort of treatment-resistant pediatric epilepsy, purified CBD was efficacious in a broad range of pediatric epilepsies and was well tolerated as an adjunctive anti-seizure medication. This medication may be considered in pharmacoresistant pediatric epilepsies in conditions beyond its FDA-labeled indications."

Journal • CNS Disorders • Epilepsy • Insomnia • Pediatrics • Sleep Disorder

CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: University of Wisconsin, Madison | Trial completion date: May 2027 ➔ May 2028 | Trial primary completion date: May 2027 ➔ May 2028

Trial completion date • Trial primary completion date • CNS Disorders • Orthopedics • Urinary Incontinence • Urology

CBD-CUD Study: A Randomised Controlled Trial of Cannabidiol (CBD) for the treatment of Cannabis Use Disorder (CUD) (ANZCTR) - P3 | N=250 | Completed | Sponsor: University of Sydney | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Psychiatry • Substance Abuse

Epi-Pre: Epidiolex Trial for Presymptomatic Treatment of Sturge-Weber Syndrome (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Johns Hopkins University

New P2 trial

RCT of CBD for Anxiety in Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Breast Cancer • Oncology • Psychiatry • Solid Tumor

Differential Pulse Voltammetric Analysis of Cannabidiol on Fluorine-Doped Tin Oxide (FTO) Electrode Interface: Quantification in Pharmaceutical Oil with Assessment of Electrode Surface Stability. (PubMed, Sensors (Basel)) - "This work presents the use of an unmodified fluorine-doped tin oxide (FTO) electrode as an electrochemical sensor for the stable and highly reproducible detection of cannabidiol (CBD) in an oral pharmaceutical formulation (CBD-OS)...The FTO electrode exhibited high reproducibility, withstanding more than 20 consecutive additions to the same electrode without loss of response, thanks to its intrinsic stability and the strategic use of forced convection. The use of an unmodified electrode enabled the development of a simple, reproducible, robust, and cost-effective analytical methodology for CBD analysis in pharmaceutical samples."

Journal

CAN-SAD: Investigating the Effects of Cannabidiol on Social Anxiety Disorder (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Massachusetts Institute of Technology | Trial completion date: Sep 2026 ➔ May 2027 | Trial primary completion date: May 2026 ➔ May 2027

Trial completion date • Trial primary completion date • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Psychiatric aspects of commercially available products containing cannabidiol (PubMed, Nervenarzt) - "There is no robust evidence of health benefits associated with CPC. However, given the levels of exposure, product deficiencies, and the EFSA safety concerns, it must be assumed that there are relevant health risks (particularly hepatotoxicity) associated with the use of CPC."

Journal • Review • Anesthesia • CNS Disorders • Infectious Disease • Psychiatry • Sleep Disorder • CYP2C19 • CYP3A4

A systematic review of highly purified cannabidiol in developmental and epileptic encephalopathies and complex treatment-resistant epilepsies: Nonseizure outcomes. (PubMed, Epilepsy Res) - "This SLR mainly identified observational studies with moderate to high bias risk. The available evidence suggests CBD may improve various nonseizure outcomes in patients with DEEs and complex TREs, while underscoring the need for rigorous confirmatory studies."

Journal • Review • CNS Disorders • Epilepsy • Psychiatry

EpiGOAL: A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGS (clinicaltrials.gov) - P4 | N=40 | Not yet recruiting | Sponsor: Jazz Pharmaceuticals

New P4 trial • CNS Disorders • Epilepsy

A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy (clinicaltrials.gov) - P2/3 | N=260 | Not yet recruiting | Sponsor: Jazz Pharmaceuticals

New P2/3 trial • CNS Disorders • Epilepsy

A Study to Evaluate the Safety and Efficacy of CBD-OS in Participants With DEE (clinicaltrials.gov) - P3 | N=120 | Not yet recruiting | Sponsor: Jazz Pharmaceuticals

New P3 trial • CNS Disorders • Epilepsy

Evaluating the pharmacokinetics, efficacy and safety of low-dose cannabidiol. (PubMed, Br J Clin Pharmacol) - "PK studies using low-dose, oral CBD (all included PK studies ≤150 mg) showed that peak (Cmax) and total exposure (area under the curve [AUC]) were 5- to 100-fold lower than a typical 20 mg/kg dose of Epidiolex...Drug-drug interactions (DDIs) with Δ9-tetrahydrocannabinol, amitriptyline, and hydromorphone were observed at low doses (10, 30, 50, 60, 100 mg), which may have implications for patients who are co-administering non-prescription CBD with other medications...No studies reported serious adverse events associated with low-dose CBD, which was well tolerated. In conclusion, low doses of CBD show very little evidence of any biological effect or therapeutic value."

Journal • PK/PD data • Review • Addiction (Opioid and Alcohol) • Cardiovascular • CNS Disorders • Crohn's disease • Dermatology • Fibromyalgia • Gastroenterology • Glaucoma • Immunology • Movement Disorders • Multiple Sclerosis • Musculoskeletal Pain • Pain • Parkinson's Disease • Psoriasis • Rheumatology • Sleep Disorder

Co-Creation of the EpiCom Clinical Trial: Bringing the Tuberous Sclerosis Complex Patient Community, Healthcare Professionals, and the Pharmaceutical Industry Together. (PubMed, Patient) - P4 | "Proactively involving PAGs, caregivers, and HCPs enabled the co-creation of a study that explicitly addresses outcomes important to the broader TSC community. This patient- and caregiver-informed approach of EpiCom also highlights the need for stronger collaboration between industry and PAGs in clinical trials, including the opportunities and challenges of trial implementation."

Journal • CNS Disorders • Epilepsy • Mental Retardation • Psychiatry

Effects of pimavanserin, xanomeline and highly-purified plant-derived cannabidiol on MK-801-induced behaviours in mice relevant to psychosis. (PubMed, J Psychopharmacol) - "These results suggest that hpCBD, like PIM and XAN, demonstrates putative antipsychotic-like activity in classic mouse assays relevant to psychosis, consistent with positive clinical data in patients with psychosis."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • Schizophrenia • DRD2

Steroid Hormone Changes after Short-Term High-Dose Exposure to Cannabidiol in Healthy Subjects: An Exploratory Study. (PubMed, Med Cannabis Cannabinoids) - "Cannabis-derived cannabidiol (CBD; Epidiolex®) is FDA-approved for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex, yet its effects on human steroid hormone regulation remain unclear...All subjects received methylphenidate on the final clinical day for an additional independent study objective...A significant decrease in the precursor steroid 21-OH-progesterone was observed in the CBD group compared with the placebo group...All measured hormone levels remained within physiological ranges. This study provides novel evidence that CBD modulates key components of the steroidogenic and endocrine systems, revealing previously unappreciated endocrine effects in humans."

Journal • CNS Disorders • Epilepsy

Cannabidiol as an adjunct in refractory paroxysmal sympathetic hyperactivity following severe traumatic brain injury: a case report. (PubMed, J Med Case Rep) - "This case highlights a potential adjunctive role for cannabidiol in refractory PSH following severe TBI. While causality cannot be inferred from a single observation, the sustained clinical improvement after failure of conventional therapies warrants further prospective investigation."

Journal • Anesthesia • Cardiovascular • CNS Disorders • Epilepsy • Hepatology • Hypertension • Liver Failure • Vascular Neurology

An improved method for quantification of cannabidiol, Δ9-tetrahydrocannabinol, and their metabolites in human plasma and urine. (PubMed, J Pharm Biomed Anal) - "This protocol was used to assess the influence of an oral capsule of CBD (BSPG CBD BRAINS Bioceutical laboratories) on the pharmacokinetics of CBD and its metabolites in plasma and urine relative to an FDA approved CBD formulation (Epidiolex®)...This newly developed analytical method successfully quantified CBD and its metabolites in both plasma and urine, contributing valuable data to the understanding of CBD pharmacokinetics in different oral products. This study's findings have important implications for optimizing CBD administration and assessing therapeutic outcomes."

Journal

DEMURE: Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial (clinicaltrials.gov) - P3 | N=40 | Not yet recruiting | Sponsor: Montefiore Medical Center | Trial completion date: Dec 2027 ➔ May 2028 | Initiation date: May 2026 ➔ Oct 2026 | Trial primary completion date: Dec 2027 ➔ May 2028

Trial completion date • Trial initiation date • Trial primary completion date • Substance Abuse

EpiTALY: Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY (clinicaltrials.gov) - P=N/A | N=111 | Active, not recruiting | Sponsor: Jazz Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Epilepsy