Trial reportEpilepsia2022
Time to onset of cannabidiol treatment effect and resolution of adverse events in tuberous sclerosis complex: Post hoc analysis of randomized controlled phase 3 trial GWPCARE6.
Trial report in Epilepsia, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02544763 (A Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P, CBD) as Add-on Therapy in Patients With Tuberous Sclerosis Complex Who Experience Inadequately-controlled Seizures
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.
- Adverse Events of Cannabidiol Use in Patients With Epilepsy: A Systematic Review and Meta-analysis.JAMA network open · 2023Pooled it
- Cys-loop receptors on cannabinoids: All high?Frontiers in physiology · 2022Pooled it
- Trial
- Long-term cannabidiol treatment for seizures in patients with tuberous sclerosis complex: An open-label extension trial.Epilepsia · 2022Trial
- Time to onset of cannabidiol (CBD) treatment effect in Lennox-Gastaut syndrome: Analysis from two randomized controlled trials.Epilepsia · 2021Trial
- Epilepsy: Molecular Pathogenesis and Emerging Therapies.MedComm · 2026Review
- Cannabinoid Therapies in Less-Common Disorders: Clinical Evidence and Formulation Strategies.Diseases (Basel, Switzerland) · 2026Review
- Update of the statement on safety of cannabidiol as a novel food.EFSA journal. European Food Safety Authority · 2026Article
- Article
- 19 patients report seizure freedom with medical cannabis oil treatment for drug-resistant epilepsy: a case series.Frontiers in neuroscience · 2025Article
- Consensus panel recommendations for the optimization of EPIDIOLEX® treatment for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex.Epilepsia open · 2024Review
- A Cost-Utility Analysis of Add-On Cannabidiol Versus Usual Care Alone for the Treatment of Seizures Associated with Tuberous Sclerosis Complex in England and Wales.PharmacoEconomics - open · 2024Article
- Cannabinoids and endocannabinoids as therapeutics for nervous system disorders: preclinical models and clinical studies.Neural regeneration research · 2024Review
- Pharmacovigilance on cannabidiol as an antiepileptic agent.Frontiers in pharmacology · 2023Article
- Cannabidiol and epilepsy in Brazil: a current review.Arquivos de neuro-psiquiatria · 2022Review
- Time to onset of cannabidiol treatment effects in Dravet syndrome: Analysis from two randomized controlled trials.Epilepsia · 2021Article
- Review of the treatment options for epilepsy in tuberous sclerosis complex: towards precision medicine.Therapeutic advances in neurological disorders · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 7 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo estimate the timing of cannabidiol (CBD) treatment effect (seizure reduction and adverse events [AEs]) onset, we conducted a post hoc analysis of GWPCARE6 (NCT02544763), a randomized, placebo-controlled, phase 3 trial in patients with drug-resistant epilepsy associated with tuberous sclerosis complex (TSC).
methodsPatients received plant-derived pharmaceutical formulation of highly purified CBD (Epidiolex; 100 mg/ml oral solution) at 25 mg/kg/day (CBD25) or 50 mg/kg/day (CBD50) or placebo for 16 weeks (4-week titration, 12-week maintenance). Treatment started at 5 mg/kg/day for all groups and reached 25 mg/kg/day on Day 9 and 50 mg/kg/day on Day 29. Percentage change from baseline in TSC-associated seizure (countable focal or generalized) count was calculated by cumulative day (i.e., including all previous days). Time to onset and resolution of AEs were evaluated.
resultsOf 224 patients, 75 were randomized to CBD25, 73 to CBD50, and 76 to placebo. Median (range) age was 11.3 (1.1-56.8) years. Patients had discontinued a median (range) of 4 (0-15) antiseizure medications and were currently taking 3 (0-5). Difference in seizure reduction between CBD and placebo emerged on Day 6 (titrated dose, 15 mg/kg/day) and became nominally significant (p < .049) by Day 10. Separation between placebo and CBD in ≥50% responder rate also emerged by Day 10. Onset of AEs occurred during the first 2 weeks of the titration period in 61% of patients (CBD25, 61%; CBD50, 67%; placebo, 54%). In patients with an AE, resolution occurred within 4 weeks of onset in 42% of placebo and 27% of CBD patients and by end of trial in 78% of placebo and 51% of CBD patients. SIGNIFICANCE: Onset of treatment effect occurred within 6-10 days. AEs lasted longer for CBD than placebo, but the most common (diarrhea, decreased appetite, and somnolence) resolved during the 16-week trial in most patients.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.