zachw

Largest Study Cbd Study To Date Presented At American Epilepsy Society

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Abst. 3.397), 2015

EFFICACY AND SAFETY OF EPIDIOLEX (CANNABIDIOL) IN CHILDREN AND YOUNG ADULTS WITH TREATMENT-RESISTANT EPILEPSY: UPDATE FROM THE EXPANDED ACCESS PROGRAM

Authors: Orrin Devinsky, Elizabeth Thiele, Linda Laux, Daniel Friedman, Anup Patel, Judith Bluvstein, Michael Chez, Charuta Joshi, Roberta Cilio, Francis Filloux, Evan Fertig, Angus Wilfong, Paul D. Lyons, Yong Park, Robert Flamini, Matthew Wong, Ian Miller, Eric Marsh

 

Content:

 

RATIONALE:Cannabidiol (CBD) is the most abundant non-psychoactive cannabinoid in the cannabis plant. Animal studies demonstrate anticonvulsant efficacy in multiple species and models. Anecdotal reports suggest efficacy in children with treatment-resistant epilepsies (TRE), including Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS). We report current results in our expanded access treatment program. 

 

METHODS:Children and young adults with TRE in an expanded access compassionate use program for CBD were enrolled in a prospective observational study. During the 4 week baseline, parents/caregivers kept prospective seizure diaries of all countable motor seizure types. Patients received a highly standardized pharmaceutical plant-derived, purified CBD. (Epidiolex: GW Pharma), at a gradually increasing dose from 2-5 mg/kg/day until intolerance occurred or a maximum dose of 25 mg/kg/day was achieved. Patients were seen at regular intervals of 2-4 weeks during the initial 12 weeks of therapy. Testing for hematologic, liver, kidney function and AED levels was performed at baseline, and after 4, 8 and 12 weeks of CBD therapy.

 

RESULTS:261 patients received at least 3 months of treatment and had available data at last group data collection (136 (52%) were male; average age 11.8 years, range 4 months-41 years; average weight 38 kg; range 6.4-127). The most common diagnoses were DS (44; 17%) and LGS (40; 15%). The average # of concomitant AEDs was 3.0. After 3 months of therapy, the median overall seizure frequency reduction was 45.1% in all patients and 62.7% in DS patients. For LGS patients, the median reduction of atonic seizures from baseline was 71.1%. Among all patients, 47% had a ≥50% reduction in seizures. Seizure-freedom at 3 months occurred in 9% of patients and 13% of DS patients. Clobazam co-therapy was associated with a higher rate of treatment response (≥50% convulsive seizure reduction): 57% v. 39%; this may reflect elevations in the desmethyl clobazam metabolite. Safety data from 313 patients representing 180 patient years was available at 16 sites. Adverse events in ≥10% of patients included somnolence (23%), diarrhea (23%), fatigue (17%), decreased appetite (17%), convulsions (17%) and vomiting (10%). 14 patients (4%) had an adverse event leading to discontinuation of CBD. 36 patients (12%) withdrew primarily due to lack of efficacy. Serious Adverse Events (SAEs) were reported in 106 patients (34%), including 7 deaths, none of which were considered treatment-related. 16 patients (5%) had SAEs that were considered treatment-related, including altered liver enzymes (4 pts; all were also on valproate and clobazam), status epilepticus/convulsion (4), diarrhea (4), decreased weight (3), thrombocytopenia (1), and others.

 

CONCLUSIONS:These results from an uncontrolled study support the animal studies and prior reports showing that CBD may be a promising treatment for TRE and it is generally well-tolerated in doses up to 25mg/kg/day. Epidiolex is now being investigated in randomized controlled studies in DS and LGS.

 

 

- See more at: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2414222#sthash.IpsKtXZ1.dpuf

Edited by zachw
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Patients received a highly standardized pharmaceutical plant-derived, purified CBD. (Epidiolex: GW Pharma), at a gradually increasing dose from 2-5 mg/kg/day until intolerance occurred or a maximum dose of 25 mg/kg/day was achieved.

 

i must have mised this part.

 

its nice that gw tested up to 25mg/kg/day. i was worried their 2.5mg spray would be worthless for efficacy.

 

25mg/kg would be 1.8 grams of cbd per day for a 160lb adult.

 

 

from the sativex documentation:

Tetrahydrocannabinol - cannabidiol is available as a spray for the mouth. It is sprayed under the tongue or on the inside of the cheeks. The usual starting adult dose of tetrahydrocannabinol - cannabidiol is one spray 2 times a day on the first day. You should start to feel its effects in about 30 minutes. Do not spray the back of the throat or into the nose. After the first day, you may be advised to increase the dose by 1 spray every 24 hours, spacing the doses evenly. No more than 12 doses should be used over a 24 hour period.

 

The maintenance dose depends on each person's medical condition and individual response to the medication. The right dose is reached when you achieve acceptable pain relief with tolerable side effects. Most people require between 4 and 8 doses daily.

it takes roughly 30 minutes to take effect sprayed in the mouth under the tongue. 4-8 doses in say a 16 hour day would be one dose every 2-4 hours.

 

so each dose lasts for 2-4 hours. interesting. that seems to be less effects time than a medible effect, closer to the time for an inhaled smoke or vaporization administration of cannabis.

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