Table 2.
Pharmacological efficacy of cannabinoid products tested in clinical trials.
Clinical Trial Number/Year | Patients | Description | Results | References |
---|---|---|---|---|
NCT02224560/2018 | Adults and children (2–55 years of age, n = 225) with Lennox-Gastaut syndrome | Randomized, double-blind trial 14-week study of two dose levels (10 mg/kg/day and 20 mg/kg/day), to evaluate the efficacy and safety of CBD (GWP42003-P) | It confirmed a reduction in the number of seizures | [59] |
NCT02224690/2015 | Patients (2-55 years of age) with Lennox-Gastaut syndrome (n = 171) | GWP42003-P in a single dose of 20 mg/kg/day for 14 weeks | The results confirmed the reduction in seizure frequency after administration | [60] |
NCT02091206/ | Children (4–10 years) suffering from Dravet syndrome (n = 34) | It was a safety and pharmacokinetic dose-ranging study of Epidiolex (5, 10 and 20 mg/kg/day) with a duration of 21 days | Results confirmed that Epidiolex is a safe drug; however, it caused more adverse effects than placebo did | [61] |
NCT02091375/ 2015 |
Children and adults (2–18 years) with Dravet syndrome (n = 120) | Evaluation of the antiepileptic efficacy of GWP42003-P | Results confirmed that CBD (20 mg/kg/day/14 weeks) resulted in 43% of the patients experiencing a reduction in seizure frequency of 50% or more. Three of these patients became seizure-free | [62] |
NCT02700412/ 2015 |
Eighty epileptic subjects between 18 and 99 years |
This interventional study evaluated the safety and tolerability of Epidiolex at various doses between 5 and 50 mg/kg/day as an add-on drug for the treatment of drug-resistant debilitating epilepsy | Results confirmed Epidiolex seizure reduction in 63.6% of patients after 12 weeks of treatment | [63] |
NCT02695537/ 2015 |
Children and adults (1–19 years), n = 89 | Evaluation of the safety and tolerability of Epidiolex for the treatment of drug-resistant debilitating epilepsy | The results confirmed after administration of various doses between 5 and 50 mg/kg/day a seizure reduction of 63.6% after 12 weeks of treatment | [63] |