Cannabis Öl Schweiz - Darvet Syndrom Cbd - Vapor Spirit
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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British manufacturer, which presented the as yet unpublished results at a press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
previously been treated with four others Active substances had been treated
unsuccessfully.
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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
convulsions.
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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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