Study of Safety and Efficacy of MGCND00EP1 as an Add on Treatment in Children and Adolescents With Resistant Epilepsies

Summary

EudraCT: 2018-003887-29 Objective:To evaluate the safety and efficacy of: MGCND00EP1 from MGC PHARMACEUTICALS d.o.o. Study Design: Randomized, double blind, placebo controlled parallel grouped study Sample Size: 103 subjects Study Population: Children from 1 year to 18 years of age Comparator Product :Placebo solution, oral IMP Product : MGCND00EP1 (each ml of solution containing 100 mg of cannabidiol and 5 mg of (-)-trans-Δ9- tetrahydrocannabinol as active substance) from MGC PHARMACEUTICALS D.O.O. According to dosing scheme up to 25 mg/kg BW per day or maximum daily dose 800 mg (whichever smaller) for 6 weeks titration and 6 weeks of treatment, oral administration

Timeline

Start

2024-05-30

Primary completion

2024-05-30

Completion

2024-05-30

Outcome

Outcome not reported

Stopped: “Failure to overcome bureaucratic obstacles within timeframe.”

Publications

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• Background Goodwin SW, Lambrinos AI, Ferro MA, Sabaz M, Speechley KN. Development and assessment of a shortened Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55). Epilepsia. 2015 Jun;56(6):864-72. doi: 10.1111/epi.13000. Epub 2015 Apr 25.
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• Background Sativex smpc , 20.09.2018
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Drugs

Indications