WO2022017930A1 - Utilisation de cannabidiol dans le traitement de crises associées au syndrome de jeavon - Google Patents

Utilisation de cannabidiol dans le traitement de crises associées au syndrome de jeavon Download PDF

Info

Publication number
WO2022017930A1
WO2022017930A1 PCT/EP2021/069858 EP2021069858W WO2022017930A1 WO 2022017930 A1 WO2022017930 A1 WO 2022017930A1 EP 2021069858 W EP2021069858 W EP 2021069858W WO 2022017930 A1 WO2022017930 A1 WO 2022017930A1
Authority
WO
WIPO (PCT)
Prior art keywords
cbd
preparation
seizures
cannabinoids
syndrome
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2021/069858
Other languages
English (en)
Inventor
Daniel Adam CHECKETTS
Kevin James CRAIG
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
GW Research Ltd
Original Assignee
GW Research Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by GW Research Ltd filed Critical GW Research Ltd
Publication of WO2022017930A1 publication Critical patent/WO2022017930A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/4015—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42—Oxazoles
    • A61K31/423—Oxazoles condensed with carbocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/53—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/658—Medicinal preparations containing organic active ingredients o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants

Definitions

  • the present invention relates to the use of cannabidiol (CBD) for the treatment of seizures associated with rare epilepsy syndromes.
  • CBD cannabidiol
  • the seizures associated with rare epilepsy syndromes that are treated are those which are experienced in patients diagnosed with Jeavon’s syndrome.
  • the types of seizures include absence, myoclonic-absence, myoclonic, focal seizures without impairment and focal seizures with secondary generalisation.
  • the dose of CBD is between 5 mg/kg/day to 50 mg/kg/day.
  • the CBD used is in the form of a highly purified extract of cannabis such that the CBD is present at greater than 95% of the total extract (w/w) and the cannabinoid tetrahydrocannabinol (THC) has been substantially removed, to a level of not more than 0.15% (w/w).
  • the CBD used is in the form of a botanically derived purified CBD which comprises greater than or equal to 98% (w/w) CBD and less than or equal to 2% (w/w) of other cannabinoids. More preferably the other cannabinoids present are THC at a concentration of less than or equal to 0.1% (w/w); CBD-C1 at a concentration of less than or equal to 0.15% (w/w); CBDV at a concentration of less than or equal to 0.8% (w/w); and CBD-C4 at a concentration of less than or equal to 0.4% (w/w).
  • the botanically derived purified CBD preferably also comprises a mixture of both trans-THC and cis-THC. Alternatively, a synthetically produced CBD is used.
  • the other cannabinoids present are THC at a concentration of about 0.01% to about 0.1% (w/w); CBD-C1 at a concentration of about 0.1% to about 0.15% (w/w); CBDV at a concentration of about 0.2% to about 0.8% (w/w); and CBD-C4 at a concentration of about 0.3% to about 0.4% (w/w).
  • THC is present at a concentration of about 0.02% to about 0.05% (w/w).
  • the CBD may be formulated for administration separately, sequentially or simultaneously with one or more AED or the combination may be provided in a single dosage form.
  • Epilepsy occurs in approximately 1% of the population worldwide, (Thurman et ai, 2011) of which 70% are able to adequately control their symptoms with the available existing anti-epileptic drugs (AED). However, 30% of this patient group, (Eadie etal., 2012), are unable to obtain seizure freedom from the AED that are available and as such are termed as suffering from intractable or “treatment-resistant epilepsy” (TRE).
  • TRE treatment-resistant epilepsy
  • Intractable or treatment-resistant epilepsy was defined in 2009 by the International League against Epilepsy (I LAE) as “failure of adequate trials of two tolerated and appropriately chosen and used AED schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom ” (Kwan et al., 2009).
  • Childhood epilepsy is a relatively common neurological disorder in children and young adults with a prevalence of approximately 700 per 100,000. This is twice the number of epileptic adults per population.
  • the main symptom of epilepsy is repeated seizures.
  • Clinical observations and electroencephalography (EEG) tests are conducted and the type(s) of seizures are classified according to the ILEA classification.
  • Generalized seizures where the seizure arises within and rapidly engages bilaterally distributed networks, can be split into six subtypes: tonic-clonic (grand mal) seizures; absence (petit mal) seizures; clonic seizures; tonic seizures; atonic seizures and myoclonic seizures.
  • Focal (partial) seizures where the seizure originates within networks limited to only one hemisphere, are also split into sub-categories.
  • the seizure is characterized according to one or more features of the seizure, including aura, motor, autonomic and awareness / responsiveness.
  • a seizure begins as a localized seizure and rapidly evolves to be distributed within bilateral networks this seizure is known as a bilateral convulsive seizure, which is the proposed terminology to replace secondary generalized seizures (generalized seizures that have evolved from focal seizures and are no longer remain localized).
  • focal seizures where the subject’s awareness / responsiveness is altered are referred to as focal seizures with impairment and focal seizures where the awareness or responsiveness of the subject is not impaired are referred to as focal seizures without impairment.
  • Jeavon’s syndrome is a rare type of epilepsy. It is sometimes referred to as epilepsy with eyelid myoclonia. It is one of the most distinctive reflex syndromes of idiopathic generalized epilepsy characterized by the triad of eyelid myoclonia with and without absences, eye-closure- induced seizures, EEG paroxysms, or both, and photosensitivity.
  • Eyelid myoclonia with or without absences is a form of epileptic seizure manifesting with myoclonic jerks of the eyelids with or without a brief absence. These are mainly precipitated by closing of the eyes and lights. Eyelid myoclonia is the defining seizure type of Jeavon’s syndrome.
  • Anti-epileptic drugs including valproic acid, lamotrigine and ethosuximide may help treat seizures in Jeavon’s syndrome. Levetiracetam and clobazam may also be helpful.
  • CBD Cannabidiol
  • the patent EP3157512 describes using CBD to treat a number of different childhood epilepsy syndromes one of which is listed is Jeavon’s syndrome. There are no data in the patent which demonstrate or suggest that the use of CBD may be efficacious in the treatment of seizures associated with Jeavon’s syndrome.
  • Example 1 demonstrates use of CBD was able to reduce absence seizures whilst Example 2 provides efficacy of the CBD in treating myoclonic absence seizures.
  • GB 2568929 describes the concurrent use of CBD and an immunosuppressant drug in the treatment of childhood-onset epilepsy syndromes one of which is listed is Jeavon’s syndrome. There are no data in the patent application which demonstrate or suggest that the use of CBD may be efficacious in the treatment of seizures associated with Jeavon’s syndrome.
  • GB 2539472 and GB 2569961 both disclose the use of highly purified CBD for the treatment of various types of seizures, but do not show any data to suggest efficacy in the treatment of Jeavon’s syndrome
  • CBD cannabidiol
  • the seizures associated with Jeavon’s syndrome are absence, myoclonic-absence, myoclonic, focal seizures without impairment and focal seizures with secondary generalisation.
  • the CBD preparation comprises greater than 95% (w/w) CBD and not more than 0.15% (w/w) tetrahydrocannabinol (THC).
  • the CBD preparation comprises greater than or equal to 98% (w/w) CBD and less than or equal to 2% (w/w) other cannabinoids, wherein the less than or equal to 2% (w/w) other cannabinoids comprise the cannabinoids tetrahydrocannabinol (THC); cannabidiol- C1 (CBD-C1); cannabidivarin (CBDV); and cannabidiol-C4 (CBD-C4), and wherein the THC is present as a mixture of trans-THC and cis-THC.
  • THC cannabinoids tetrahydrocannabinol
  • CBD-C1 cannabidiol- C1
  • CBDDV cannabidivarin
  • CBD-C4 cannabidiol-C4
  • the CBD preparation is used in combination with one or more concomitant anti-epileptic drugs (AED).
  • AED concomitant anti-epileptic drugs
  • the one or more AED is selected from the group consisting of: valproic acid, clobazam, lamotrigine, zonisamide and ethosuximide.
  • the CBD is present is isolated from cannabis plant material.
  • the CBD is present as a synthetic preparation.
  • the dose of CBD is greater than 5 mg/kg/day. More preferably the dose of CBD is 20 mg/kg/day. More preferably the dose of CBD is 25 mg/kg/day. More preferably the dose of CBD is 50 mg/kg/day.
  • a method of treating seizures associated with Jeavon’s syndrome comprising administering a cannabidiol (CBD) preparation to the subject in need thereof.
  • CBD cannabidiol
  • cannabinoids Over 100 different cannabinoids have been identified, see for example, Handbook of Cannabis, Roger Pertwee, Chapter 1, pages 3 to 15. These cannabinoids can be split into different groups as follows: Phytocannabinoids; Endocannabinoids and Synthetic cannabinoids (which may be novel cannabinoids or synthetically produced phytocannabinoids or endocannabinoids).
  • phytocannabinoids are cannabinoids that originate from nature and can be found in the cannabis plant.
  • the phytocannabinoids can be isolated from plants to produce a highly purified extract or can be reproduced synthetically.
  • “Highly purified cannabinoids” are defined as cannabinoids that have been extracted from the cannabis plant and purified to the extent that other cannabinoids and non-cannabinoid components that are co-extracted with the cannabinoids have been removed, such that the highly purified cannabinoid is greater than or equal to 95% (w/w) pure.
  • Synthetic cannabinoids are compounds that have a cannabinoid or cannabinoid-like structure and are manufactured using chemical means rather than by the plant.
  • Phytocannabinoids can be obtained as either the neutral (decarboxylated form) or the carboxylic acid form depending on the method used to extract the cannabinoids. For example, it is known that heating the carboxylic acid form will cause most of the carboxylic acid form to decarboxylate into the neutral form.
  • Treatment-resistant epilepsy (TRE) or “intractable epilepsy” is defined as per the I LAE guidance of 2009 as epilepsy that is not adequately controlled by trials of one or more AED.
  • Myoclonic seizures are characterised by a ‘muscle jerk’. Myoclonic seizures are brief but can happen in clusters (many happening close together in time) and often happen shortly after waking. In myoclonic seizures the person is conscious, but they are classified as generalised seizures.
  • Myoclonic-absence seizures are characterised by the patient’s neck, back, and arms become stiff or rigid (tonic contraction). There is ratchet-like jerking of the head, arms, and legs. The patient is not aware and has a staring facial expression. The loss of awareness might be subtle and hard to notice.
  • “Absence seizures” also may be called a "petit mal” these types of seizure cause a loss of awareness for a short time. They mainly affect children although can happen at any age. During an absence seizure, a person may: stare blankly into space; look like they are "daydreaming"; flutter their eyes; make slight jerking movements of their body or limbs. The seizures usually only last up to 15 seconds and may occur several times a day.
  • “Focal Seizures” are defined as seizures which originate within networks limited to only one hemisphere. What happens during the seizure depends on where in the brain the seizure happens and what that part of the brain normally does.
  • “Focal seizure with secondary generalisation” seizures start in a limited area on one side of the brain and spread to involve both sides. This is different from a generalized onset seizure, which starts on both sides of the brain.
  • the drug substance used is a liquid carbon dioxide extract of high-CBD containing chemotypes of Cannabis sativa L. which had been further purified by a solvent crystallization method to yield CBD.
  • the crystallisation process specifically removes other cannabinoids and plant components to yield greater than or equal to 95% CBD.
  • CBD is highly purified because it is produced from a cannabis plant rather than synthetically there is a small number of other cannabinoids which are co-produced and co-extracted with the CBD. Details of these cannabinoids and the quantities in which they are present in the medication are as described in Table A below.
  • Table A Composition of highly purified CBD extract > - greater than NMT - not more than
  • the drug substance used in the trials is a liquid carbon dioxide extract of high-CBD containing chemotypes of Cannabis sativa L. which had been further purified by a solvent crystallization method to yield CBD.
  • the crystallisation process specifically removes other cannabinoids and plant components to yield greater than 95% CBD w/w, typically greater than 98% w/w.
  • Cannabis sativa L. plants are grown, harvested, and processed to produce a botanical extract (intermediate) and then purified by crystallization to yield the CBD (botanically derived purified CBD).
  • the plant starting material is referred to as Botanical Raw Material (BRM); the botanical extract is the intermediate; and the active pharmaceutical ingredient (API) is CBD, the drug substance.
  • BRM Botanical Raw Material
  • API active pharmaceutical ingredient
  • Table B CBD botanical raw material specification
  • Table C Specification of an exemplary botanically derived purified CBD preparation
  • the purity of the botanically derived purified CBD preparation was greater than or equal to 98%.
  • the botanically derived purified CBD includes THC and other cannabinoids, e.g., CBDA, CBDV, CBD-C1, and CBD-C4.
  • the CBD preparation comprises not more than 0.15% THC based on total amount of cannabinoid in the preparation. In some embodiments, the CBD preparation comprises about 0.01% to about 0.1% THC based on total amount of cannabinoid in the preparation. In some embodiments, the CBD preparation comprises about 0.02% to about 0.05% THC based on total amount of cannabinoid in the preparation.
  • the CBD preparation comprises about 0.2% to about 1.0% CBDV based on total amount of cannabinoid in the preparation. In some embodiments, the CBD preparation comprises about 0.2% to about 0.8% CBDV based on total amount of cannabinoid in the preparation. [0056] In some embodiments, the CBD preparation comprises about 0.3% to about 0.5%
  • CBD-C4 based on total amount of cannabinoid in the preparation.
  • the CBD preparation comprises about 0.3% to about 0.4% CBD-C4 based on total amount of cannabinoid in the preparation.
  • the CBD preparation comprises about 0.1% to about 0.15% CBD-C1 based on total amount of cannabinoid in the preparation.
  • Distinct chemotypes of the Cannabis sativa L. plant have been produced to maximize the output of the specific chemical constituents, the cannabinoids. Certain chemovars produce predominantly CBD. Only the (-)-trans isomer of CBD is believed to occur naturally. During purification, the stereochemistry of CBD is not affected.
  • High CBD chemovars were grown, harvested, dried, baled and stored in a dry room until required.
  • the botanical raw material (BRM) was finely chopped using an Apex mill fitted with a 1 mm screen. The milled BRM was stored in a freezer prior to extraction.
  • the BDS produced using the methodology above was dispersed in C5-C12 straight chain or branched alkane.
  • the mixture was manually agitated to break up any lumps and the sealed container then placed in a freezer for approximately 48 hours.
  • the crystals were isolated via vacuum filtration, washed with aliquots of cold C5-C12 straight chain or branched alkane, and dried under a vacuum of ⁇ 10mb at a temperature of 60°C until dry.
  • the botanically derived purified CBD preparation was stored in a freezer at -20°C in a pharmaceutical grade stainless steel container, with FDA food grade approved silicone seal and clamps.
  • the botanically derived purified CBD used in the clinical trial described in the invention comprises greater than or equal to 98% (w/w) CBD and less than or equal to 2% (w/w) of other cannabinoids.
  • the other cannabinoids present are THC at a concentration of less than or equal to 0.1% (w/w); CBD-C1 at a concentration of less than or equal to 0.15% (w/w); CBDV at a concentration of less than or equal to 0.8% (w/w); and CBD-C4 at a concentration of less than or equal to 0.4% (w/w).
  • the botanically derived purified CBD used additionally comprises a mixture of both trans-THC and cis-THC. It was found that the ratio of the trans-THC to cis-THC is altered and can be controlled by the processing and purification process, ranging from 3.3:1 (trans-THC:cis- THC) in its unrefined decarboxylated state to 0.8:1 (trans-THC:cis-THC) when highly purified. [0067] Furthermore, the cis-THC found in botanically derived purified CBD is present as a mixture of both the (+)-cis-THC and the (-)-cis-THC isoforms.
  • CBD preparation could be produced synthetically by producing a composition with duplicate components.
  • Example 1 describes the use of a botanically derived purified CBD in an open label, expanded-access program to investigate the clinical efficacy and safety of purified pharmaceutical cannabidiol formulation (CBD) in the treatment of patients diagnosed with Jeavon’s syndrome.
  • CBD cannabidiol formulation
  • EXAMPLE 1 CLINICAL EFFICACY AND SAFETY OF PURIFIED PHARMACEUTICAL CANNABIDIOL (CBD) IN THE TREATMENT OF PATIENTS DIAGNOSED WITH JEAVON'S SYNDROME. Study design
  • Subjects were required to be on one or more AEDs at stable doses for a minimum of two weeks prior to baseline and to have stable vagus nerve stimulation (VNS) settings and ketogenic diet ratios for a minimum of four weeks prior to baseline.
  • VNS vagus nerve stimulation
  • Patients were administered botanically derived purified CBD in a 100 mg/ml_ sesame oil- based solution at an initial dose of between 4.4 and 20 milligrams per kilogram per day (mg/kg/day) in two divided doses. Dose was then increased weekly by 5mg/kg/day to a goal of 20 to 25 mg/kg/day.
  • a maximum dose of 50 mg/kg/day could be utilised for patients who were tolerating the medication but had not achieved seizure control; these patients had further weekly titration by 5mg/kg/day.
  • Seizure frequency, intensity, and duration were recorded by caregivers in a diary during a baseline period of at least 28 days. Changes in seizure frequency relative to baseline were calculated after at least 2 weeks and at defined timepoints of treatment.
  • Patients may be defined as responders if they had more than 50% reduction in seizure frequency compared to baseline.
  • the percent change in seizure frequency was calculated as follows:
  • % change (weekly seizure frequency time interval) - (weekly seizure frequency Baseline) seizure frequency (weekly seizure frequency Baseline)
  • the percent change of seizure frequency may be calculated for any time interval where seizure number has been recorded.
  • the percent change of seizure frequency for the end of the treatment period was calculated as follows:
  • % reduction ((weekly seizure frequency Baseline) - (weekly seizure frequency End)) x100 seizure frequency
  • VPA valproic acid
  • CLB clobazam
  • LTG lamotrigine
  • ZNS zonisamide
  • ETH ethosuximide
  • Tables 2A-2D illustrate the seizure frequency for each patient as well as the dose of
  • Table 2A Seizure frequency data for Patient 1
  • Patient 3 was treated for 144 weeks and experienced a 100% reduction in absence seizures, myoclonic-absence seizures and focal seizures with secondary generalisation over the treatment period.
  • Patient 4 was treated for 84 weeks and experienced a 60.4% reduction in absence seizures over the treatment period.
  • CBD was effective in reducing the frequency of the following seizure types: absence, myoclonic-absence and focal seizures with impairment. Significantly, one patient became seizure free of absence seizures, myoclonic-absence seizures and focal seizures with secondary generalisation after 144 weeks (patients #3) of CBD treatment.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Engineering & Computer Science (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne l'utilisation de cannabidiol (CBD) pour le traitement de crises associées à des syndromes épileptiques rares. En particulier, les crises associées à des syndromes épileptiques rares qui sont traitées sont celles survenant chez des patients chez lesquels on a diagnostiqué un syndrome de Jeavon. Dans un autre mode de réalisation, les types de crises comprennent les crises d'absence, d'absence myocloniques, myocloniques, focales sans altération de la conscience et focales avec généralisation secondaire. De préférence, la dose de CBD est comprise entre 5 mg/kg/jour et 50 mg/kg/jour.
PCT/EP2021/069858 2020-07-20 2021-07-15 Utilisation de cannabidiol dans le traitement de crises associées au syndrome de jeavon Ceased WO2022017930A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB2011128.2 2020-07-20
GB2011128.2A GB2597286A (en) 2020-07-20 2020-07-20 Use of cannabidiol in the treatment of seizures associated with rare epilepsy syndromes

Publications (1)

Publication Number Publication Date
WO2022017930A1 true WO2022017930A1 (fr) 2022-01-27

Family

ID=72339084

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2021/069858 Ceased WO2022017930A1 (fr) 2020-07-20 2021-07-15 Utilisation de cannabidiol dans le traitement de crises associées au syndrome de jeavon

Country Status (2)

Country Link
GB (1) GB2597286A (fr)
WO (1) WO2022017930A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015193668A1 (fr) * 2014-06-17 2015-12-23 Gw Pharma Limited Utilisation de cannabidiol dans le traitement de l'épilepsie
GB2539472A (en) 2015-06-17 2016-12-21 Gw Res Ltd Use of cannabinoids in the treatment of epilepsy
GB2568929A (en) 2017-12-01 2019-06-05 Gw Res Ltd Use of cannabinoids in the treatment of epilepsy
GB2569961A (en) 2018-01-03 2019-07-10 Gw Res Ltd Pharmaceutical

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015193668A1 (fr) * 2014-06-17 2015-12-23 Gw Pharma Limited Utilisation de cannabidiol dans le traitement de l'épilepsie
EP3157512A1 (fr) 2014-06-17 2017-04-26 GW Pharma Limited Utilisation de cannabidiol dans le traitement de l'épilepsie
GB2539472A (en) 2015-06-17 2016-12-21 Gw Res Ltd Use of cannabinoids in the treatment of epilepsy
GB2568929A (en) 2017-12-01 2019-06-05 Gw Res Ltd Use of cannabinoids in the treatment of epilepsy
GB2569961A (en) 2018-01-03 2019-07-10 Gw Res Ltd Pharmaceutical

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
KUCHENBUCH MATHIEU ET AL: "Add-on cannabidiol significantly decreases seizures in 3 patients with SYNGAP1 developmental and epileptic encephalopathy", EPILEPSIA OPEN, vol. 5, no. 3, 4 June 2020 (2020-06-04), pages 496 - 500, XP055847803, ISSN: 2470-9239, Retrieved from the Internet <URL:https://onlinelibrary.wiley.com/doi/full-xml/10.1002/epi4.12411> DOI: 10.1002/epi4.12411 *
PORCARI ET AL.: "Efficacy of artisanal preparations of cannabidiol for the treatment of epilepsy: Practical experiences in a tertiary medical center", EPILEPSY AND BEHAVIOUR, 2018, pages 3 - 15

Also Published As

Publication number Publication date
GB202011128D0 (en) 2020-09-02
GB2597286A (en) 2022-01-26

Similar Documents

Publication Publication Date Title
EP4182024A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à des mutations dans le gène syngap1
EP4181888A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à des syndromes épileptiques rares liés à des anomalies structurales du cerveau
WO2022017945A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à des syndromes épileptiques rares liés à des anomalies génétiques
EP4181902A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à des syndromes épileptiques rares liés à des anomalies génétiques
EP4181894A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à des syndromes épileptiques rares liés à des anomalies génétiques
WO2020234569A1 (fr) Utilisation de cannabidiol dans le traitement de spasmes épileptiques
WO2022017947A1 (fr) Utilisation du cannabidiol dans le traitement de crises associées à des syndromes épileptiques rares liés à des anomalies génétiques
WO2022017949A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à une mutation de chrna4
EP4181890A1 (fr) Utilisation du cannabidiol dans le traitement de crises associées au syndrome de rett
WO2022017909A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à des syndromes d&#39;épilepsies rares associées à des anomalies structurales du cerveau
EP4181899A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à des syndromes épileptiques rares liés à des anomalies génétiques
EP4259112A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à des syndromes épileptiques chez des patients prenant du brivaracétam
WO2022017956A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées au virus de l&#39;herpès simplex
WO2022017930A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées au syndrome de jeavon
WO2022017958A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées au syndrome du bébé secoué
WO2022017954A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à des syndromes épileptiques rares liés à des anomalies structurales du cerveau
WO2022017944A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à une dégénérescence cérébrale bilatérale
WO2022017957A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à un accident vasculaire cérébral ou à une hémorragie cérébrale
WO2022017915A1 (fr) Cannabidiol destiné à être utilisé dans le traitement de crises associées à des lésions cérébrales
WO2022017943A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à une déficience en arginase
WO2022017913A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à des syndromes épileptiques rares liés à des anomalies génétiques
WO2022017925A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées au syndrome épileptique multifocal
WO2022017950A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à la sclérose temporale mésiale bilatérale
WO2022017929A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à la lissencéphalie
WO2022017936A1 (fr) Utilisation de cannabidiol dans le traitement de crises associées à des syndromes d&#39;épilepsies rares liés à des anomalies structurales du cerveau

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21751985

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 21751985

Country of ref document: EP

Kind code of ref document: A1