cbd oil for infantile spasms

Cannabidiol Therapy for Refractory Epilepsy and Seizure Disorders

Cannabis-derived cannabinoids have neuroactive properties. Recently, there has been emerging interest in the use of cannabidiol (CBD)-enriched products for treatment of drug-resistant epilepsy. In 2018, the FDA approved the use of CBD-rich Epidiolex for two severe forms of epilepsy in children (Lennox-Gastaut and Dravet syndromes). Experimental research supports the use of CBD in many CNS disorders, though the mechanisms underlying its anticonvulsant and neuroprotective effects remain unclear. CBD has been shown to reduce inflammation, protect against neuronal loss, normalize neurogenesis, and act as an antioxidant. These actions appear to be due to the multimodal mechanism of action of CBD in the brain. This chapter briefly describes the current information on cannabis pharmacology with an emphasis on the clinical utility of CBD in the treatment of refractory epilepsies and other related seizure conditions. Clinical trials are ongoing for other forms of epilepsy and refractory seizures associated with infantile spasms, tuberous sclerosis, and Rett syndrome. Overall, adjunct CBD has been found to be generally safe and effective for treatment-resistant seizures in children with severe early-onset epilepsy. Whether an add-on CBD is efficacious for the long-term treatment of various epilepsy and seizure types in adults being tested in various clinical trials.

Keywords: CBD, THC; Cannabidiol; Cannabis; Epilepsy; Marijuana; Refractory seizure.

West Syndrome and CBD – Medical Marijuana

West Syndrome, also known as infantile spasms, is a rare, severe form of epilepsy in infants. CBD oil, when used under the supervision of a doctor, may reduce seizures in West syndrome. CBD has less negative, long-term, detrimental health effects when compared to seizure medications used in infants, and may be more effective in intractable epilepsy.

What is West Syndrome?

West syndrome is considered a rare disease that occurs in fewer than 6 out of every 10,000 babies. Infants can show signs of West syndrome between the ages of 3 to 13 months, but the most common age of onset is 5 months.

West syndrome has several names: infantile spasms, infantile epileptic encephalopathy, or infantile myoclonic encephalopathy. It makes up about 30% of infantile epilepsy.

West syndrome may or may not have an identified cause. Some causes are brain injury or lack of oxygen during birth, brain tumors or infections, encephalitis, vitamin B deficiency, chromosomal abnormalities, or a rare genetic condition called tuberous sclerosis. Babies with West syndrome may also experience developmental delays, display autistic traits, and have cognitive deficits.

Signs and Symptoms of West Syndrome

Seizures are the most prominent sign of West syndrome and can occur in clusters. The baby may appear as if he or she is twitching of having uncontrollable muscle movements.

Jackknife seizures are common in West syndrome where the baby suddenly bends forward at the waist. Other signs of a seizure include rapid or slow breathing, sweating, turning pale or red, crying, watery eyes, or wide pupils.

Some children may develop normally and then experience a regression of motor skills, including sitting up or rolling over, after developing West syndrome.

Fatalities are increased in West syndrome. 5 out of every 100 children perish before the age of 5 and about 61% won’t make it to the age of 10.

Having West syndrome or infantile spasms increases the risk of developing other forms of rare, drug-resistant childhood epilepsy, such as Lennox-Gastaut syndrome.

West Syndrome Treatment

Current treatments include anti-seizure and convulsant medications, surgical removal of damaged brain tissue, sedative medications, steroid treatments, or vitamin B if doctors believe it is caused by a vitamin B deficiency.

West Syndrome and CBD – Medical Marijuana

West syndrome is extremely distressing for parents and their children. Medications may reduce the number or frequency of seizures in some, but not all cases. They often have negative side effects that can further harm a baby’s health, resulting in vision loss or digestive issues.

CBD is providing a lot of hope as an alternative treatment for West syndrome and infantile spasms.

Clinical trials and parent reports overwhelmingly demonstrate people are having success in reducing or eliminating seizures with CBD oil. CBD is a cannabinoid in medical marijuana that is non-intoxicating. While it may seem controversial to give medical marijuana to children, it is important to remember that it is a safe, natural substance. CBD is proven safe for use in children and does not produce intoxicating effects.

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The effectiveness of CBD in treating seizures has prompted medical marijuana programs in some states. Desperate parents have relocated to obtain the medicine legally for their children.

The FDA recently approved a synthetic form of CBD, called Epidiolex, for use in children over the age of 2 with severe, drug-resistant epilepsy.

Reports are abundant of parents who were able to reduce or eliminate drug-resistant seizures and clinical trials have confirmed these results.

In one survey of 117 parents who used CBD extracts for intractable epilepsy, 85% reported seizure reduction, and 14% became seizure free. Some of the parents in this survey reported using CBD for infantile spasms.

In another survey of 53 parents with children ages 9 months through 18 years using CBD oil for intractable epilepsy, 83% reported a reduction of seizures and 16% became seizure free. A small percentage reported an aggravation of seizures.

In an Israeli clinical trial of 74 children with drug-resistant epilepsy, 52% of the patients had a 50% reduction of seizures using CBD oil in a 20:1 CBD to THC ratio.

Clinical trials of Epidiolex, the synthetic form of CBD, showed significant reductions in seizures in children with Dravet syndrome and Lennox-Gastaut syndrome – two related forms of severe childhood epilepsy that often don’t respond to traditional treatments.

One double-blind placebo controlled study showed patients who added CBD to traditional therapies significantly reduced seizures in Lennox-Gastaut syndrome.

Another similar study showed doses of both 10 milligrams and 20 milligrams of CBD oil per 1 kilogram of body weight per day reduced seizures in Lennox-Gastaut syndrome when compared to a placebo. Lennox-Gastaut syndrome may develop as children with West syndrome age.

There are no studies specific to West syndrome and CBD oil due to its early onset in infancy. The American Epilepsy Society and Epilepsy Foundation are supportive of using CBD and medical marijuana as potential treatments for epilepsy and seizures.

Using CBD for West Syndrome

Patients have found success using CBD oil in combination with other therapies or CBD oil on its own. The dosage of CBD oil commonly used for epilepsy in children is 10 to 20 milligrams of CBD oil per 1 kilogram of body weight each day, according to research. While this is the average dose, it is always important to speak with a knowledgeable doctor who is supportive of CBD when determining a dose for your child. CBD and all medications used in infants and children should be overseen by a knowledgeable doctor.

Because other medications may not have worked and can have long term damaging effects, many parents are turning to CBD to relieve seizures as a safer, sometimes more effective option.

CBD oil has not cured seizures in 100% of patients, but a majority of children find at least a significant reduction in seizures. Since CBD is a safe, natural substance, it may be worth exploring for parents and children who can’t find seizure relief through traditional treatments.

To use medical marijuana effectively for West syndrome, parents should use it under doctor supervision and be knowledgeable about dosing, THC and CBD, and using the medicine.

West syndrome is a very scary and expensive condition. Sabina Holistic Health helps medical marijuana patients with approved conditions afford medical marijuana. We believe that all patients who need CBD or medical cannabis should be able to incorporate it into their treatment plans affordably. Seizures and epilepsy are usually approved for CBD treatment.

Find more patient resources for using cannabis for wellness and as medicine:

Our Mission

Sabina Holistic Health is a nonprofit that provides financial assistance to medical marijuana patients with serious medical conditions that are approved in their states. All patients who need medical cannabis should be able to access it affordably. If you or a loved one need assistance, we may be able to help. Request medical cannabis assistance or donate to patients with serious medical conditions.

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Disclaimer: This post gives information about medical marijuana as demonstrated through scientific study and reported by doctors and patients. This content is for informational purposes only and is not a substitute for professional medical advice, diagnoses, and treatment.

Resources:

Ben-Zeev B. (2020). Medical Cannabis for Intractable Epilepsy in Childhood: A Review. Rambam Maimonides medical journal, 11(1), e0004. https://doi.org/10.5041/RMMJ.10387

Blesching, Uwe. The Cannabis Health Index: Combining the Science of Medical Marijuana with Mindfulness Techniques to Heal 100 Chronic Symptoms and Diseases. North Atlantic Books, 2015.

Backes, M., Weil, A., & McCue, J. D. (2017). Cannabis pharmacy: the practical guide to medical marijuana. New York: Black Dog & Leventhal Publishers.

Devinsky, O., Cross, J. H., Laux, L., Marsh, E., Miller, I., Nabbout, R., . . . Wright, S. (2017). Trial of cannabidiol for drug-resistant seizures in the dravet syndrome. New England Journal of Medicine, 376(21), 2011-2020. doi:10.1056/nejmoa1611618

Devinsky, O., Patel, A. D., Cross, J. H., Villanueva, V., Wirrell, E. C., Privitera, M., . . . Zuberi, S. M. (2018). Effect of cannabidiol on drop seizures in the lennox–gastaut syndrome. New England Journal of Medicine, 378(20), 1888-1897. doi:10.1056/nejmoa1714631

Infantile spasms project. (2019, May 8). Retrieved March 6, 2021, from https://infantilespasmsproject.org/index.php/medical-marijuana

Moskowitz, M. H. (2017). Medical cannabis: a guide for patients, practitioners, and caregivers. Virginia Beach, VA: Koehler Books.

Tzadok M, Uliel-Siboni S, Linder I, Kramer U, Epstein O, Menascu S, Nissenkorn A, Yosef OB, Hyman E, Granot D, Dor M, Lerman-Sagie T, Ben-Zeev B. CBD-enriched medical cannabis for intractable pediatric epilepsy: The current Israeli experience. Seizure. 2016 Feb;35:41-4. doi: 10.1016/j.seizure.2016.01.004. Epub 2016 Jan 6. PMID: 26800377.

West syndrome. (2019, April 23). Retrieved March 6, 2021, from https://rarediseases.org/rare-diseases/west-syndrome/

Wolf, L. G., & Wolf, M. (2016). The medical marijuana dispensary: understanding, medicating, and cooking with cannabis. Berkeley, CA: Althea Press.

CBD for Infantile Spasms Given OK by The FDA

Insys Therapeutics, Inc. (NASDAQ: INSY) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its pharmaceutical cannabidiol (CBD) candidate for the treatment of infantile spasms (IS).

“We are pleased to have received orphan drug designation for CBD to treat infantile spasms, a catastrophic form of childhood epilepsy,” said Michael L. Babich, President and Chief Executive Officer. “If successful, our CBD product could offer certain children the potential to attain seizure control and to potentially achieve an improved level of development. It is also an opportunity to have a significant, positive impact in the lives of these unfortunate children and their families. We are updating our current IND to initiate a clinical trial at UCLA.”

Raman Sankar, MD, PhD, lead investigator for Insys’ planned CBD trial for the treatment of IS with Dr. Shaun Hussain at UCLA, stated, “The population that we are studying in this clinical trial is infants who have failed currently approved therapies for a debilitating disease associated with detrimental effects on their short- and long-term development. I am pleased to be leading this investigation of CBD which, if successful, could offer a new treatment option for these infants for whom there are limited or no currently available therapies.”

Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity upon approval, as well as certain financial incentives that can help support its development.

Insys expects that its new, DEA-inspected facility in Round Rock, Texas, will enable it to manufacture ample quantities of CBD for its research and commercial plans.

About Pharmaceutical CBD

Cannabidiol (CBD) is one of at least 60 active cannabinoids identified in cannabis. CBD is considered to have a wider scope of medical applications than tetrahydrocannabinol (THC), and appears to have anti-convulsive action in animal models.

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Insys’ pharmaceutical CBD is over 99.5% pure cannabidiol. It is synthesized to be chemically identical to the CBD extracted from cannabis, and is produced in a controlled environment. The FDA issued a Drug Master File (DMF) to Insys for its CBD active pharmaceutical ingredient in May 2014.

About Infantile Spasms

An infantile spasm (IS), also known as West Syndrome, is a specific type of seizure seen in an epilepsy syndrome of infancy and childhood. West Syndrome is characterized by infantile spasms, developmental regression, and a specific pattern on electroencephalography (EEG) testing called hypsarrhythmia (chaotic brain waves). The onset of infantile spasms is usually in the first year of life, typically between 4-8 months. The seizures primarily consist of a sudden bending forward of the body with stiffening of the arms and legs; some children arch their backs as they extend their arms and legs.(1)an Drug Designation for Its Pharmaceutical Cannabidiol for the Treatment of Infantile Spasms
PHOENIX, AZ–(Marketwired – Aug 4, 2015) – Insys Therapeutics, Inc. (NASDAQ: INSY) (“Insys” or “the Company”) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its pharmaceutical cannabidiol (CBD) candidate for the treatment of infantile spasms (IS).

“We are pleased to have received orphan drug designation for CBD to treat infantile spasms, a catastrophic form of childhood epilepsy,” said Michael L. Babich, President and Chief Executive Officer. “If successful, our CBD product could offer certain children the potential to attain seizure control and to potentially achieve an improved level of development. It is also an opportunity to have a significant, positive impact in the lives of these unfortunate children and their families. We are updating our current IND to initiate a clinical trial at UCLA.”

Raman Sankar, MD, PhD, lead investigator for Insys’ planned CBD trial for the treatment of IS with Dr. Shaun Hussain at UCLA, stated, “The population that we are studying in this clinical trial is infants who have failed currently approved therapies for a debilitating disease associated with detrimental effects on their short- and long-term development. I am pleased to be leading this investigation of CBD which, if successful, could offer a new treatment option for these infants for whom there are limited or no currently available therapies.”

Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity upon approval, as well as certain financial incentives that can help support its development.

Insys expects that its new, DEA-inspected facility in Round Rock, Texas, will enable it to manufacture ample quantities of CBD for its research and commercial plans.

About Pharmaceutical CBD

Cannabidiol (CBD) is one of at least 60 active cannabinoids identified in cannabis. CBD is considered to have a wider scope of medical applications than tetrahydrocannabinol (THC), and appears to have anti-convulsive action in animal models.

Insys’ pharmaceutical CBD is over 99.5% pure cannabidiol. It is synthesized to be chemically identical to the CBD extracted from cannabis, and is produced in a controlled environment. The FDA issued a Drug Master File (DMF) to Insys for its CBD active pharmaceutical ingredient in May 2014.

About Infantile Spasms

An infantile spasm (IS), also known as West Syndrome, is a specific type of seizure seen in an epilepsy syndrome of infancy and childhood. West Syndrome is characterized by infantile spasms, developmental regression, and a specific pattern on electroencephalography (EEG) testing called hypsarrhythmia (chaotic brain waves). The onset of infantile spasms is usually in the first year of life, typically between 4-8 months. The seizures primarily consist of a sudden bending forward of the body with stiffening of the arms and legs; some children arch their backs as they extend their arms and legs.(1)