{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T02:47:35Z","timestamp":1785898055976,"version":"3.56.0"},"reference-count":12,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2021,12,1]],"date-time":"2021-12-01T00:00:00Z","timestamp":1638316800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2021,12,1]],"date-time":"2021-12-01T00:00:00Z","timestamp":1638316800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cannabis &amp; Cannabinoid Research"],"published-print":{"date-parts":[[2021,12,1]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>We assessed the efficacy, safety, and tolerability of cannabidivarin (CBDV) as add-on therapy in adults with inadequately controlled focal seizures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods:<\/jats:title>\n                    <jats:p>\n                      One hundred and sixty-two participants (CBDV\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      =81; placebo\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      =81) were enrolled. After a 4-week baseline, participants titrated from 400 to 800\u2009mg CBDV twice daily (b.i.d.) (or placebo) over 2 weeks, followed by 6 weeks stable dosing (at 800\u2009mg b.i.d.) and a 12-day taper period. The primary endpoint was the change from baseline in focal seizure frequency during the 8-week treatment period. Secondary endpoints included additional efficacy measures relating to seizures, physician- and participant-reported outcomes, change in the use of rescue medication, cognitive assessments, and safety.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Median baseline focal seizure frequencies were 17\u201318 per 28 days in both groups, and similar reductions in frequency were observed in the CBDV (40.5%) and placebo (37.7%) groups during the treatment period (treatment ratio [% reduction] CBDV\/placebo: 0.95 [4.6]; confidence interval: 0.78\u20131.17 [\u221216.7 to 21.9];\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      =0.648). There were no differences between the CBDV and placebo groups for any seizure subtype. There were no significant treatment differences between CBDV and placebo groups for any of the secondary efficacy outcome measures. Overall, 59 (72.8%) of participants in the CBDV group and 39 (48.1%) in the placebo group had \u22651 treatment-emergent adverse event (AE); the 3 most common were diarrhea, nausea, and somnolence. The incidence of serious AEs was low (3.7% in the CBDV group vs. 1.2% in the placebo group). There was little or no effect of CBDV on vital signs, physical examination, or electrocardiogram findings. Elevations in serum transaminases (alanine aminotransferase or aspartate aminotransferase) to levels &gt;3\u00d7upper limit of normal occurred in three participants taking CBDV (two discontinued as a result) and one taking placebo; however, none met the criteria for potential Hy's Law cases.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>It is likely the 40.5% seizure reduction with CBDV represents an appropriate pharmacological response in this population with focal seizures. The placebo response was, however, high, which may reflect the participants' expectations of CBDV, and a treatment difference from placebo was not observed. CBDV was generally well tolerated.<\/jats:p>\n                    <jats:p>Clinical Trial Registration number: NCT02365610.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/can.2020.0075","type":"journal-article","created":{"date-parts":[[2021,2,17]],"date-time":"2021-02-17T11:16:12Z","timestamp":1613560572000},"page":"528-536","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":26,"title":["A Phase 2 Randomized Controlled Trial of the Efficacy and Safety of Cannabidivarin as Add-on Therapy in Participants with Inadequately Controlled Focal Seizures"],"prefix":"10.1177","volume":"6","author":[{"given":"Martin J.","family":"Brodie","sequence":"first","affiliation":[{"name":"Epilepsy Unit, University of Glasgow, Glasgow, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Czapinski","sequence":"additional","affiliation":[{"name":"Epilepsy and Migraine Treatment Center, Krakow, Poland."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ladislav","family":"Pazdera","sequence":"additional","affiliation":[{"name":"Vestra Clinics - Dedicated Research Clinics, Rychnov nad Kneznou, Czech Republic."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josemir W.","family":"Sander","sequence":"additional","affiliation":[{"name":"NIHR University College London Hospitals Biomedical Research Centre, UCL Queen Square Institute of Neurology, London, WC1N 3BG, United Kingdom."},{"name":"Chalfont Centre for Epilepsy, Chalfont St. Peter, United Kingdom."},{"name":"Stichting Epilepsie Instellingen Nederland (SEIN), Heemstede, Netherlands."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel","family":"Toledo","sequence":"additional","affiliation":[{"name":"Epilepsy Unit, Neurology Department, Vall d'Hebron Hospital, Barcelona, Spain."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariana","family":"Napoles","sequence":"additional","affiliation":[{"name":"GW Research Ltd, Cambridge, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Farhad","family":"Sahebkar","sequence":"additional","affiliation":[{"name":"Greenwich Biosciences, Inc., Carlsbad, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashley","family":"Schreiber","sequence":"additional","affiliation":[{"name":"GW Research Ltd, Cambridge, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on Behalf of the GWEP1330 Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomas","family":"Nezadal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jana","family":"Slonkova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Altman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K\u00e1lm\u00e1n","family":"F\u00fcle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00c1gnes","family":"Horv\u00e1th","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Kelemen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u00e1muel","family":"Komoly","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Banach","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iwona","family":"Kurkowska-Jastrzebska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pawe\u0142","family":"Lisewski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Merce","family":"Falip","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodrigo","family":"Rocamora","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manny","family":"Bagary","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2021,12,9]]},"reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.3732\/ajb.91.6.966"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.1111\/bph.12321"},{"key":"e_1_3_5_4_2","doi-asserted-by":"publisher","DOI":"10.1021\/cn5000524"},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.neuropharm.2019.01.002"},{"key":"e_1_3_5_6_2","doi-asserted-by":"crossref","unstructured":"Posner K Brent D Lucas C et al. 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