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.
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:
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.
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.
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
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Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms
Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of epilepsy that usually strikes children in the first year of life. There is a great need for safe and effective therapies in the treatment of IS. This need is even more important for infants and toddlers still sick after being treated with medicine that is already available.
This is a multi-center study to evaluate the efficacy and safety of Cannabidiol Oral Solution (CBD) in the treatment of children aged 6 months through 36 months with a diagnosis of infantile spasms who have not responded to first line therapies.
The overall study duration is expected to be 64 weeks for those subjects who respond to CBD treatment. The maximum possible study duration for each patient is approximately 64 weeks, however a subject will be deemed to have completed the study after 58 weeks.
|Condition or disease||Intervention/treatment||Phase|
|Spasms, Infantile||Drug: Cannabidiol Oral Solution||Phase 2|
A protocol amendment in May 2016 created two parts to this trial: Part A (the extended treatment period) and Part B (the safety treatment period), whose objectives are as follows:
Primary Part A: To evaluate the efficacy of Cannabidiol Oral Solution in treating refractory infantile spasms (IS).
- To evaluate the safety of Cannabidiol Oral Solution in treating refractory infantile spasms.
- To assess the long-term safety of Cannabidiol Oral Solution as an adjunctive treatment for subjects with Infantile Spasms (IS)
- To establish the continued efficacy of Cannabidiol Oral Solution in maintaining seizure control in subjects with IS
- To assess the global status of subjects taking Cannabidiol Oral Solution for an extended period of time determined by various qualitative assessments
- To monitor for changes in plasma levels of Cannabidiol Oral Solution during long-term treatment of subjects with IS
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study to Assess the Efficacy and Safety of Cannabidiol Oral Solution for the Treatment of Refractory Infantile Spasms|
|Actual Study Start Date :||January 27, 2016|
|Actual Primary Completion Date :||September 6, 2016|
|Actual Study Completion Date :||September 6, 2016|
The dose of Cannabidiol Oral Solution will begin at 20 mg/kg/day [10 mg/kg twice per day (BID)], will be adjusted at any time if the investigator feels the safety or well-being of the participant is at risk, and will be titrated up or down according to protocol-stipulated parameters and at the investigator’s discretion after Day 14 to enhance efficacy. Dose will not exceed 40 mg/kg/day.
Part A: Percentage of Participants Who Are Considered Complete Responders at Day 14 [ Time Frame: Day 14 ]
Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-electroencephalogram (EEG) at Day 14.
- Part A: Percentage of Participants With Absence of Infantile Spasms at Day 14 [ Time Frame: Day 14 ]
- Part A: Percentage of Participants With Absence of Hypsarrhythmia at Day 14 [ Time Frame: Day 14 ]
- Part A: Median Reduction in Seizure-burden Comparing Video-EEG at Baseline to Repeat Video-EEG at Day 14 [ Time Frame: Baseline, Day 14 ]
- Part A: Parent Impression of Efficacy and Tolerability of Study Drug [ Time Frame: Visit 3 (Day 14), Visit 4 (Week 4), Visit 5 (Week 8), Visit 6 (Week 10), and end of study. ]
Parent impression of efficacy and tolerability, as measured by Clinical Global Impression-Global Improvement Scale (CGI-I), was summarized by visit and status of response (Complete/Partial and No Response) at Visit 3 (Day 14), Visit 4 (Week 4), Visit 5 (Week 8), Visit 6 (Week 10), and end of study. The CGI-I was also analyzed in a continuous scale, as follows: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, and 7 = Very much worse
Partial response was defined as a substantive change in background EEG or reduction in spasms on video EEG obtained at Day 14.
Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-EEG at Day 14.
Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-EEG at Day 14.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||6 Months to 36 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Meets protocol-specified criteria for qualification, including infantile spasms
- Parent(s)/caregiver(s) fully comprehend and sign the informed consent form, understand all study procedures, and can communicate satisfactorily with the Investigator and study coordinator.
History or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters
Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- the safety or well-being of the participant or study staff
- the analysis of results
During the Safety Treatment and Follow-up Periods, subjects are not to receive the following:
- any cannabinoids (CBD, Δ9-tetrahydrocannabinol (THC), hemp oil, Realm Oil or marijuana)
- any other investigational drug or investigational device
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551731
Synthetic pharmaceutical grade cannabidiol for treatment of refractory infantile spasms: A multicenter phase-2 study
Purpose: Limited data suggest that cannabidiol (CBD) may be effective for treatment of refractory infantile spasms (IS). This study was designed to more rigorously evaluate the efficacy and safety of synthetic CBD in the treatment of IS.
Methods: Children six to 36 months of age with IS that failed treatment with both adrenocorticotropic hormone (ACTH) and vigabatrin (VGB) were eligible for enrollment. Children receiving clobazam were excluded. After baseline overnight video-electroencephalography (vEEG) to confirm diagnosis and ascertain hypsarrhythmia, patients were treated with synthetic CBD oral solution (20 mg/kg/day). Overnight video-EEG was repeated after 14 days, and both baseline and repeat video-EEGs were completely de-identified and reviewed in a pairwise fashion by an independent, blinded pediatric electroencephalographer. The primary efficacy endpoint was freedom from spasms and hypsarrhythmia on day 14.
Results: Nine patients were enrolled, comprising an older (median age = 23 months) cohort with long-standing IS (median duration = 13 months) and numerous prior treatment failures (median = 6). One patient responded to therapy and eight patients exhibited neither clinical nor electrographic response.
Conclusions: The immediate but temporary response in a single patient suggests that CBD oral solution is not particularly effective in highly refractory cases, but may, nevertheless, be effective in younger patients with shorter durations of IS. Further study, examining both short- and long-term outcomes, is warranted to further evaluate the efficacy and safety of CBD oral solution in the treatment of IS.
Keywords: Cannabis; Epileptic spasms; Hypsarrhythmia; West syndrome.
Copyright © 2019. Published by Elsevier Inc.
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