cannabidivarin (GWP42006) / Jazz - LARVOL DELTA

CBDV vs Placebo in Children and Adults up to Age 30 With Prader-Willi Syndrome (PWS) (clinicaltrials.gov) - P2 | N=14 | Completed | Sponsor: Montefiore Medical Center | Active, not recruiting ➔ Completed | Trial primary completion date: Aug 2024 ➔ Oct 2024

Trial completion • Trial primary completion date • Prader–Willi syndrome

Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Montefiore Medical Center | Trial completion date: Jul 2024 ➔ Dec 2025 | Trial primary completion date: Jul 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders

CBDV vs Placebo in Children and Adults up to Age 30 With Prader-Willi Syndrome (PWS) (clinicaltrials.gov) - P2; N=26; Recruiting; Sponsor: Montefiore Medical Center; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Prader–Willi syndrome

Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Montefiore Medical Center; Trial completion date: Oct 2021 ➔ Aug 2022; Trial primary completion date: Oct 2021 ➔ Aug 2022

Clinical • Trial completion date • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders

Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Montefiore Medical Center; Trial primary completion date: Jun 2021 ➔ Oct 2021

Clinical • Trial primary completion date • Autism Spectrum Disorder • Genetic Disorders

A Phase 2 Randomized Controlled Trial of the Efficacy and Safety of Cannabidivarin as Add-on Therapy in Participants with Inadequately Controlled Focal Seizures. (PubMed, Cannabis Cannabinoid Res) - P2 | "CBDV was generally well tolerated. Clinical Trial Registration number: NCT02365610."

Clinical • Journal • P2 data • CNS Disorders • Epilepsy

Safety and Tolerability of Cannabidivarin (CBDV) in Children and Young Adults With Autism Spectrum Disorder (clinicaltrials.gov) - P2; N=1; Terminated; Sponsor: GW Research Ltd; N=30 ➔ 1; Trial completion date: Nov 2021 ➔ May 2020; Recruiting ➔ Terminated; Trial primary completion date: Oct 2021 ➔ May 2020; Study terminated due to enrollment challenges during COVID-19 pandemic.

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Autism Spectrum Disorder • Genetic Disorders

GW Pharmaceuticals Provides Preliminary Fourth Quarter and Full-Year 2020 Net Product Sales Results and 2021 Program Milestones (GlobeNewswire) - "Key Priorities for 2021: Nabiximols in the US: Continue recruitment of two ongoing pivotal MS spasticity trials and commence three additional pivotal trials in MS spasticity; Achieve data from at least one pivotal MS spasticity trial in 2021; NDA submission expected following first positive pivotal MS spasticity trial; Commence clinical program to expand future label to include spasticity associated with Spinal Cord Injury....Conduct placebo-controlled trials with both CBDV...in autism."

Clinical data • Enrollment status • New trial • sNDA • CNS Disorders

[VIRTUAL] Cannabidivarin (CBDV) Phase I Trial to Treat Epilepsy in Rett Syndrome (AES 2020) - "CBDV, at a dose of 10mg/kg/day, produced an overall significant decrease in monthly seizure burden for 80% of participants with refractory epilepsy and Rett syndrome. This dose was well tolerated by all children, with adverse events managed without drug cessation. Non-epilepsy outcome measures are to be analysed."

P1 data • CNS Disorders • Cognitive Disorders • Developmental Disorders • Epilepsy • Gastrointestinal Disorder • Movement Disorders • Rare Diseases

CBDV vs Placebo in Children and Adults up to Age 30 With Prader-Willi Syndrome (PWS) (clinicaltrials.gov) - P2; N=26; Recruiting; Sponsor: Montefiore Medical Center; Trial completion date: Oct 2020 ➔ Dec 2021; Trial primary completion date: Oct 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Prader–Willi syndrome

A Study of GWP42006 in People With Focal Seizures - Part A (clinicaltrials.gov) - P2; N=32; Completed; Sponsor: GW Research Ltd; Recruiting ➔ Completed; Trial primary completion date: Jun 2015 ➔ Oct 2015

Trial completion • Trial primary completion date • Biosimilar • Epilepsy

A Study of GWP42006 in People With Focal Seizures - Part B (clinicaltrials.gov) - P2; N=140; Recruiting; Sponsor: GW Research Ltd; N=100 ➔ 140; Trial primary completion date: Dec 2016 ➔ Aug 2017

Enrollment change • Trial primary completion date • Biosimilar • Epilepsy

A Study of GWP42006 in People With Focal Seizures - Part B (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: GW Research Ltd; Not yet recruiting ➔ Recruiting; Initiation date: Aug 2015 ➔ Mar 2016; Trial primary completion date: Apr 2016 ➔ Dec 2016

Enrollment open • Trial initiation date • Trial primary completion date • Biosimilar • Epilepsy

CBDV vs Placebo in Children and Adults up to Age 30 With Prader-Willi Syndrome (PWS) (clinicaltrials.gov) - P2; N=26; Recruiting; Sponsor: Montefiore Medical Center; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Genetic Disorders • Prader–Willi syndrome

Cannabinoids in the treatment of epilepsy: Current status and future prospects (Dovepress) - "Cannabidivarin (CBDV), the propyl analogue of CBD, showed anti-convulsant properties in pre-clinical studies, but a plant-derived, purified proprietary formulation of CBDV recently failed the Phase II RCT in patients with uncontrolled focal seizures."

Review

Safety and Tolerability of Cannabidivarin (CBDV) in Children and Young Adults With Autism Spectrum Disorder (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: GW Research Ltd; Not yet recruiting ➔ Recruiting; N=20 ➔ 30; Trial completion date: Aug 2021 ➔ Nov 2021; Initiation date: May 2019 ➔ Jan 2020; Trial primary completion date: Jul 2021 ➔ Oct 2021

Clinical • Enrollment change • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date

GW Pharmaceuticals plc reports financial results and operational progress for the second quarter ended June 30, 2019 (GW Pharma Press Release) - "IND open for 30-patient open label study in autism expected to begin recruitment by the end of 2019."

IND

Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD) (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Eric Hollander; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Safety and Tolerability of Cannabidivarin (CBDV) in Children and Young Adults With Autism Spectrum Disorder (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: GW Research Ltd

Clinical • New P2 trial