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Cannabis Öl Schweiz - Darvet Syndrom Cbd - Vapor Spirit

Cannabis-Öl Rezept - Strains Deutsch - Vape-kartuschen mit cannabis-öl

Das Dravet Syndrome, eine Epilepsie bei Säuglingen, kann mit CBD Öl therapiert werden.

Das zeigte eine Phase 3 Studie aus Grossbritannien

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New York. Cannabidiol, a psychoactive cannabinoid from the female hemp plant, reduced the

frequency of seizures in a phase 3 study in children with Dravet syndrome, a congenital

epilepsy that leads to frequent and often refractory seizures even in infancy. The

British manufacturer, which presented the as yet unpublished results at a press

conference, wants to apply for approval in the USA .

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Dravet syndrome is a relatively rare early childhood epilepsy. The frequency is estimated

at 1: 20,000-1: 40,000, the proportion of all epilepsy in childhood is around 3.5 percent.

The syndrome, which was

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only described by a French pediatrician in 1978, is caused by various genetic defects

that, for example, disrupt the formation of a sodium channel in the membrane of the

nerve cells, which significantly increases the susceptibility to seizures.

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Children with "severe myoclonic epilepsy of infancy" (SMEI) often do not become seizure

-free even under combination treatment with several anti-epileptic drugs. The seizures can

lead to status epilepticus and sudden unexpected death in epilepsy (SUDEP).

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advertisement The 120 participants in a phase 3 study by GW Pharmaceuticals, which

specializes in the development of active ingredients from the cannabis plant, were also

treated with an

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average of three other anti-epileptic drugs at the beginning of the study, after they had

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The children were on average 10 years old, 30 percent were younger than 6

years. At the start of the study, participants had an average of 13 seizures per month.

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During the 14-week treatment with Epidiolex (dose: 20mg / kg / die), the frequency

decreased by 39 percent, which was a significant advantage over the placebo arm of the

study, where there may be a decrease of 13 percent. According to the manufacturer's press

release, a series of sensitivity analyzes of the primary endpoint confirmed the

robustness of the effect.

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A publication by Orrin Devinsky’s team from the Comprehensive

Epilepsy Center at the Langone Medical Center of New York University is still pending.

The difference between Epidiolex and placebo is said to have been apparent as early as

the first month of treatment and then to have persisted over the entire treatment period.

on the subject Manufacturer's press release Registration of the study EMA Orphan Drug

Status nejm.

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The tolerability of the agent that the manufacturer extracts from female cannabis plants

is said to have been generally good.

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The most common adverse events (which occurred in

more than ten percent of patients) were: drowsiness, diarrhea, decreased appetite,

tiredness, fever, vomiting, lethargy, upper respiratory tract infections, and


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Most of the side effects were mild or moderate. Serious complications

occurred in ten patients in the Epidiolex group and three in the placebo group. Eight

patients in the drug arm discontinued treatment due to side effects compared to one

patient in the placebo arm.

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The drug has been classified as an orphan drug worthy of

funding by the US drug authorities and the manufacturer can hope for an early decision

from the FDA thanks to a “Fast Track Designation”.

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The European Medicines Agency (EMA)

has an orphan drug designation for perinatal asphyxia, another targeted indication. The

manufacturer is currently conducting two further phase 3 studies on Lennox-Gastaut

syndrome and one on tuberous sclerosis, which are also associated with epileptic seizures.

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