Trial reportCNS drugs2020
A Phase II Randomized Trial to Explore the Potential for Pharmacokinetic Drug-Drug Interactions with Stiripentol or Valproate when Combined with Cannabidiol in Patients with Epilepsy.
Trial report in CNS drugs, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02607891 (A Phase 2, Double-blind, Randomized, Placebo-controlled Pharmacokinetic Trial in 2 Parallel Groups to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and GWP42003-P in Patients With Epilepsy), which is not on this map. Cited by 32 papers, 7 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 Phase 2, Double-blind, Randomized, Placebo-controlled Pharmacokinetic Trial in 2 Parallel Groups to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and GWP42003-P in Patients With Epilepsy
Who cites it
32 citing papers in PubMed, 7 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Cannabinoids for Medical Purposes in Children: A Living Systematic Review.Acta paediatrica (Oslo, Norway : 1992) · 2025Pooled it
- Evaluation of potential drug-drug interactions with medical cannabis.Clinical and translational science · 2024Pooled it
- Systematic review of drug-drug interactions of delta-9-tetrahydrocannabinol, cannabidiol, andFrontiers in pharmacology · 2024Pooled it
- Adverse Events of Cannabidiol Use in Patients With Epilepsy: A Systematic Review and Meta-analysis.JAMA network open · 2023Pooled it
- Update on Cannabidiol Clinical Toxicity and Adverse Effects: A Systematic Review.Current neuropharmacology · 2023Pooled it
- Medical cannabinoids: a pharmacology-based systematic review and meta-analysis for all relevant medical indications.BMC medicine · 2022Pooled it
- Pooled it
- Narrative Review: Efficacy, Safety, and Tolerability of Newer Third-Generation Antiseizure Medications for Focal Epilepsy: A New Benchmark in Treatment Outcomes?Neurology and therapy · 2026Review
- Questions on Medicines, Alcohol, and Illicit Drug Interactions in the Finnish AddictionLink Online Service: A Descriptive Analysis.Nordisk alkohol- & narkotikatidskrift : NAT · 2026Article
- Cannabinoids and drug-drug pharmacokinetic interactions: Deciphering the risks.British journal of clinical pharmacology · 2026Review
- Clinical Study to Evaluate Drug Interactions of Cannabidiol with Citalopram and Morphine in Healthy Adults.Clinical pharmacology and therapeutics · 2026Article
- Ameliorating Seizures in Dravet Syndrome: A Review of Newly Approved and Investigational Drugs, RNA and Gene-Based Therapies.CNS drugs · 2026Review
- Update of the statement on safety of cannabidiol as a novel food.EFSA journal. European Food Safety Authority · 2026Article
- Genotype-Specific Safety and Pharmacokinetics of Cannabidiol in Healthy Volunteers.Clinical and translational science · 2026Article
- Evaluating cannabidiol-induced liver injury with and without valproate using a three-dimensional human hepatocyte spheroid model.Toxicology in vitro : an international journal published in association with BIBRA · 2025Article
- Article
- Cannabidiol in Foods and Food Supplements: Evaluation of Health Risks and Health Claims.Nutrients · 2025Review
- Update on Cannabidiol in Drug-Resistant Epilepsy.Indian journal of pediatrics · 2025Review
- Clinical guidance for cannabidiol-associated hepatotoxicity: A narrative review.Journal of gastroenterology and hepatology · 2024Review
- Drug-Cannabinoid Interactions in Selected Therapeutics for Symptoms Associated with Epilepsy, Autism Spectrum Disorder, Cancer, Multiple Sclerosis, and Pain.Pharmaceuticals (Basel, Switzerland) · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn recent randomized, placebo-controlled, phase III trials, highly purified cannabidiol demonstrated efficacy with an acceptable safety profile in patients with Lennox-Gastaut syndrome or Dravet syndrome. It is anticipated that antiepileptic drugs such as stiripentol and valproate will be administered concomitantly with cannabidiol.
objectivesThis trial evaluated the effect of cannabidiol on steady-state pharmacokinetics of stiripentol or valproate in patients with epilepsy, and the safety and tolerability of cannabidiol.
methodsThis phase II, two-arm, parallel-group, double-blind, randomized, placebo-controlled trial recruited male and female patients with epilepsy aged 16-55 years. Patients receiving a stable dose of stiripentol or valproate were randomized 4:1 to receive concomitant double-blind cannabidiol or placebo. Patients received plant-derived, highly purified cannabidiol medicine (Epidiolex
resultsIn total, 35 patients were recruited to the stiripentol arm (n = 14) or the valproate arm (n = 21). Both the safety and the pharmacokinetic populations of the stiripentol arm comprised 14 patients (2 placebo; 12 cannabidiol). The safety population of the valproate arm comprised 20 patients (4 placebo; 16 cannabidiol; one withdrew before receiving treatment); the pharmacokinetic population comprised 15 patients (3 placebo; 12 cannabidiol). Concomitant cannabidiol led to a small increase in stiripentol exposure (17% increase in maximum observed plasma concentration [C
conclusionsThe clinical relevance of the increase in stiripentol exposure is unknown; patients receiving cannabidiol and stiripentol concomitantly should be monitored for adverse reactions as individual patient responses may vary. Coadministration of cannabidiol did not affect the pharmacokinetics of valproate or its metabolite, 4-ene-VPA, in adult patients with epilepsy. Safety results were consistent with the known safety profile of cannabidiol at a dose of 20 mg/kg/day. Clinicaltrials.gov: NCT02607891.
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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.