Evidence map›Paper›PMID 28538134›Full record

Trial reportThe New England journal of medicine2017

Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome.

Orrin Devinsky, J Helen Cross, Linda Laux, Eric Marsh, Ian Miller, Rima Nabbout, Ingrid E Scheffer, Elizabeth A Thiele, Stephen Wright, Cannabidiol in Dravet Syndrome Study Group

6 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 676 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
676citing papers in PubMed, 8 pooled it
134.9field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT02091375 phase3completednot on this map

A Double Blind, Placebo Controlled Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

TypeinterventionalSponsorJazz PharmaceuticalsRan2015 to 2015Enrolled120ConditionsEpilepsy, Dravet SyndromeArmsGWP42003-P 20 mg/kg/day Dose, Placebo control
NCT04197102 phase2suspendednot on this mapstarted 2020, after this paper: background citation

Use of Cannabidiol (CBD) Oil in the Treatment of PTSD: A Placebo-Controlled Randomized Clinical Trial

TypeinterventionalSponsorUniversity of Texas at AustinRan2020 to 2025Enrolled150ConditionsPost Traumatic Stress DisorderArmsCBD Isolate, CBD Broad Spectrum, Placebo oil
NCT04280289 early_phase1completednot on this mapstarted 2021, after this paper: background citation

CBD Cannabis Extract: Pharmacokinetic Studies

TypeinterventionalSponsorUniversity of Mississippi, OxfordRan2021 to 2021Enrolled10ConditionsEpilepsyArmscannabidiol extract
NCT04603781 phase2 / phase3suspendednot on this mapstarted 2020, after this paper: background citation

Use of CBD Oil for Reducing the Negative Emotional Impact of COVID-19: A Randomized Placebo-Controlled Clinical Trial

TypeinterventionalSponsorUniversity of Texas at AustinRan2020 to 2023Enrolled200ConditionsAnxiety Depression, Alcohol Abuse, Substance Abuse, AngerArmsCBD Isolate, Full Spectrum CBD Oil, Broad-Spectrum CBD Oil, Placebo Oil
NCT04611438 phase3unknown statusnot on this mapstarted 2020, after this paper: background citation

A Prospective Multi-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet Syndrome and Lennox-Gastaut Syndrome

TypeinterventionalSponsorYonsei UniversityRan2020 to 2021Enrolled107ConditionsDravet Syndrome, Lennox Gastaut SyndromeArmsCannabidiol
NCT06578455 phase1completednot on this mapstarted 2024, after this paper: background citation

A Randomized, Open-Label, 4-Way Crossover, Pharmacokinetic Study to Compare CBD-NE to Epidyolex in Healthy Adult Volunteers Under Both Fed and Fasted Conditions

TypeinterventionalSponsordsm-firmenich Switzerland AGRan2024 to 2024Enrolled32ConditionsCBD Pharmacokinetics, Healthy ParticipantsArmsCannabidiol (CBD) Powder, Cannabidiol 100 MG/ML [Epidiolex]
3 · Its place in the literature

Who cites it

676 citing papers in PubMed, 8 syntheses or guidelines pooled it, 1,629 citations in OpenAlex.

  1. Pooled it
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  17. Reimagining Cannabidiol Delivery Through Carbon Nanodots.Molecules (Basel, Switzerland) · 2026
    Review
  18. Article
  19. Article
  20. Article

616 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 9 institutions in 4 countries.

Orrin DevinskyFrom the New York University Langone Comprehensive Epilepsy Center, New York (O.D.); the University College London Great Ormond Street Institute of Child Health (J.H.C.) and GW Pharmaceuticals (S.W.) - both in London; Lurie Children's Epilepsy Center, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (L.L.); the Children's Hospital of Philadelphia, Philadelphia (E.M.); Miami Children's Hospital, Miami (I.M.); Hôpital Necker-Enfants Malades, Paris (R.N.); Florey Institute, Austin Health and Royal Children's Hospital, University of Melbourne, Melbourne, VIC, Australia (I.E.S.); and Massachusetts General Hospital, Boston (E.A.T.).
J Helen CrossFrom the New York University Langone Comprehensive Epilepsy Center, New York (O.D.); the University College London Great Ormond Street Institute of Child Health (J.H.C.) and GW Pharmaceuticals (S.W.) - both in London; Lurie Children's Epilepsy Center, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (L.L.); the Children's Hospital of Philadelphia, Philadelphia (E.M.); Miami Children's Hospital, Miami (I.M.); Hôpital Necker-Enfants Malades, Paris (R.N.); Florey Institute, Austin Health and Royal Children's Hospital, University of Melbourne, Melbourne, VIC, Australia (I.E.S.); and Massachusetts General Hospital, Boston (E.A.T.).
Linda LauxFrom the New York University Langone Comprehensive Epilepsy Center, New York (O.D.); the University College London Great Ormond Street Institute of Child Health (J.H.C.) and GW Pharmaceuticals (S.W.) - both in London; Lurie Children's Epilepsy Center, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (L.L.); the Children's Hospital of Philadelphia, Philadelphia (E.M.); Miami Children's Hospital, Miami (I.M.); Hôpital Necker-Enfants Malades, Paris (R.N.); Florey Institute, Austin Health and Royal Children's Hospital, University of Melbourne, Melbourne, VIC, Australia (I.E.S.); and Massachusetts General Hospital, Boston (E.A.T.).
Eric MarshFrom the New York University Langone Comprehensive Epilepsy Center, New York (O.D.); the University College London Great Ormond Street Institute of Child Health (J.H.C.) and GW Pharmaceuticals (S.W.) - both in London; Lurie Children's Epilepsy Center, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (L.L.); the Children's Hospital of Philadelphia, Philadelphia (E.M.); Miami Children's Hospital, Miami (I.M.); Hôpital Necker-Enfants Malades, Paris (R.N.); Florey Institute, Austin Health and Royal Children's Hospital, University of Melbourne, Melbourne, VIC, Australia (I.E.S.); and Massachusetts General Hospital, Boston (E.A.T.).
Ian MillerFrom the New York University Langone Comprehensive Epilepsy Center, New York (O.D.); the University College London Great Ormond Street Institute of Child Health (J.H.C.) and GW Pharmaceuticals (S.W.) - both in London; Lurie Children's Epilepsy Center, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (L.L.); the Children's Hospital of Philadelphia, Philadelphia (E.M.); Miami Children's Hospital, Miami (I.M.); Hôpital Necker-Enfants Malades, Paris (R.N.); Florey Institute, Austin Health and Royal Children's Hospital, University of Melbourne, Melbourne, VIC, Australia (I.E.S.); and Massachusetts General Hospital, Boston (E.A.T.).
Rima NabboutFrom the New York University Langone Comprehensive Epilepsy Center, New York (O.D.); the University College London Great Ormond Street Institute of Child Health (J.H.C.) and GW Pharmaceuticals (S.W.) - both in London; Lurie Children's Epilepsy Center, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (L.L.); the Children's Hospital of Philadelphia, Philadelphia (E.M.); Miami Children's Hospital, Miami (I.M.); Hôpital Necker-Enfants Malades, Paris (R.N.); Florey Institute, Austin Health and Royal Children's Hospital, University of Melbourne, Melbourne, VIC, Australia (I.E.S.); and Massachusetts General Hospital, Boston (E.A.T.).
Ingrid E SchefferFrom the New York University Langone Comprehensive Epilepsy Center, New York (O.D.); the University College London Great Ormond Street Institute of Child Health (J.H.C.) and GW Pharmaceuticals (S.W.) - both in London; Lurie Children's Epilepsy Center, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (L.L.); the Children's Hospital of Philadelphia, Philadelphia (E.M.); Miami Children's Hospital, Miami (I.M.); Hôpital Necker-Enfants Malades, Paris (R.N.); Florey Institute, Austin Health and Royal Children's Hospital, University of Melbourne, Melbourne, VIC, Australia (I.E.S.); and Massachusetts General Hospital, Boston (E.A.T.).
Elizabeth A ThieleFrom the New York University Langone Comprehensive Epilepsy Center, New York (O.D.); the University College London Great Ormond Street Institute of Child Health (J.H.C.) and GW Pharmaceuticals (S.W.) - both in London; Lurie Children's Epilepsy Center, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (L.L.); the Children's Hospital of Philadelphia, Philadelphia (E.M.); Miami Children's Hospital, Miami (I.M.); Hôpital Necker-Enfants Malades, Paris (R.N.); Florey Institute, Austin Health and Royal Children's Hospital, University of Melbourne, Melbourne, VIC, Australia (I.E.S.); and Massachusetts General Hospital, Boston (E.A.T.).
Stephen WrightFrom the New York University Langone Comprehensive Epilepsy Center, New York (O.D.); the University College London Great Ormond Street Institute of Child Health (J.H.C.) and GW Pharmaceuticals (S.W.) - both in London; Lurie Children's Epilepsy Center, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (L.L.); the Children's Hospital of Philadelphia, Philadelphia (E.M.); Miami Children's Hospital, Miami (I.M.); Hôpital Necker-Enfants Malades, Paris (R.N.); Florey Institute, Austin Health and Royal Children's Hospital, University of Melbourne, Melbourne, VIC, Australia (I.E.S.); and Massachusetts General Hospital, Boston (E.A.T.).
Cannabidiol in Dravet Syndrome Study Group
Children's Hospital of Philadelphia · USFlorey Institute of Neuroscience and Mental Health · AUGW Pharmaceuticals (United Kingdom) · GBHôpital Necker-Enfants Malades · FRLurie Children's Hospital · USMassachusetts General Hospital · USMiami Children's Hospital · USNYU Langone Health · USUniversity College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Dravet syndrome is a complex childhood epilepsy disorder that is associated with drug-resistant seizures and a high mortality rate. We studied cannabidiol for the treatment of drug-resistant seizures in the Dravet syndrome.

methodsIn this double-blind, placebo-controlled trial, we randomly assigned 120 children and young adults with the Dravet syndrome and drug-resistant seizures to receive either cannabidiol oral solution at a dose of 20 mg per kilogram of body weight per day or placebo, in addition to standard antiepileptic treatment. The primary end point was the change in convulsive-seizure frequency over a 14-week treatment period, as compared with a 4-week baseline period.

resultsThe median frequency of convulsive seizures per month decreased from 12.4 to 5.9 with cannabidiol, as compared with a decrease from 14.9 to 14.1 with placebo (adjusted median difference between the cannabidiol group and the placebo group in change in seizure frequency, -22.8 percentage points; 95% confidence interval [CI], -41.1 to -5.4; P=0.01). The percentage of patients who had at least a 50% reduction in convulsive-seizure frequency was 43% with cannabidiol and 27% with placebo (odds ratio, 2.00; 95% CI, 0.93 to 4.30; P=0.08). The patient's overall condition improved by at least one category on the seven-category Caregiver Global Impression of Change scale in 62% of the cannabidiol group as compared with 34% of the placebo group (P=0.02). The frequency of total seizures of all types was significantly reduced with cannabidiol (P=0.03), but there was no significant reduction in nonconvulsive seizures. The percentage of patients who became seizure-free was 5% with cannabidiol and 0% with placebo (P=0.08). Adverse events that occurred more frequently in the cannabidiol group than in the placebo group included diarrhea, vomiting, fatigue, pyrexia, somnolence, and abnormal results on liver-function tests. There were more withdrawals from the trial in the cannabidiol group.

conclusionsAmong patients with the Dravet syndrome, cannabidiol resulted in a greater reduction in convulsive-seizure frequency than placebo and was associated with higher rates of adverse events. (Funded by GW Pharmaceuticals; ClinicalTrials.gov number, NCT02091375 .).

Indexed as

AdolescentAnticonvulsantsCannabidiolChildChild, PreschoolDouble-Blind MethodEpilepsies, MyoclonicFatigueFemaleHumansLiverLiver Function TestsMaleSeizuresAnticonvulsantsCannabidiol

Identifiers

PMID28538134
OpenAlexW2620218661

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.