Epidiolex

Pain, Epilepsy, Multiple Sclerosis + 5 more
Treatment
4 FDA approvals
20 Active Studies for Epidiolex

What is Epidiolex

CannabidiolThe Generic name of this drug
Treatment SummaryCannabidiol (CBD) is a chemical found in the cannabis plant. It binds to certain receptors in the body and can be used to treat a range of medical conditions, including anxiety, pain, epilepsy, and inflammation. CBD is usually taken as a pill or oil and can be found in products with different amounts of THC, the chemical that causes the ‘high’ associated with marijuana. CBD is available in Canada as a product called Sativex, which is used to treat spasticity in patients with multiple sclerosis. In the U.S., CBD is available under the brand name Epidiolex and is
Epidiolexis the brand name
image of different drug pills on a surface
Epidiolex Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Epidiolex
Cannabidiol
2018
2

Approved as Treatment by the FDA

Cannabidiol, also known as Epidiolex, is approved by the FDA for 4 uses such as Metastatic Cancer and Pain .
Metastatic Cancer
Used to treat Cancer, Advanced in combination with Dronabinol
Pain
Used to treat Severe Pain in combination with Dronabinol
Multiple Sclerosis
Used to treat Multiple Sclerosis in combination with Dronabinol
Pain
Used to treat moderate Pain in combination with Dronabinol

Effectiveness

How Epidiolex Affects PatientsResearchers are still uncovering the full effects of THC and CBD, but we know CBD can have many different effects, such as relieving pain and reducing anxiety. This is because it interacts with multiple parts of the body, such as CB1 and CB2 receptors in the endocannabinoid system, serotonin receptors, and opioid receptors. CBD may also affect the uptake of certain chemicals in the brain and block certain calcium channels.
How Epidiolex works in the bodyCBD and THC work by binding to receptors in the body, particularly the brain and spinal cord. These receptors, called cannabinoid (CB) receptors, regulate many processes in the body such as pain, memory, appetite and mood. CBD is known to act as a "negative allosteric modulator" for the CB1 receptor. This means that it can affect the receptor without completely activating it, allowing it to help with pain and reduce anxiety without causing any psychomimetic effects.

When to interrupt dosage

The measure of Epidiolex is contingent upon the diagnosed illness, including Pain, Pain and Multiple Sclerosis. The dosage also fluctuates as per the mode of administration (e.g. Oil or Kit; Oil; Solution / drops) featured in the table below.
Condition
Dosage
Administration
Tuberous Sclerosis
, 100.0 mg/mL, 8.33 mg/mL, 50.0 mg/mL, 16.7 mg/mL, 25.0 mg/mL, 33.33 mg/mL, 200.0 mg/mL, 30.0 mg/mL, 20.0 mg, 0.0015 mg/mg, 2.5 mg/pump actuation
, Spray - Buccal, Buccal, Spray, Solution, Solution - Oral, Oral, Sublingual, Oil, Oil - Sublingual, Oil - Oral, Capsule, liquid filled, Capsule, liquid filled - Oral, Patch, Topical, Patch - Topical
Pain
, 100.0 mg/mL, 8.33 mg/mL, 50.0 mg/mL, 16.7 mg/mL, 25.0 mg/mL, 33.33 mg/mL, 200.0 mg/mL, 30.0 mg/mL, 20.0 mg, 0.0015 mg/mg, 2.5 mg/pump actuation
, Spray - Buccal, Buccal, Spray, Solution, Solution - Oral, Oral, Sublingual, Oil, Oil - Sublingual, Oil - Oral, Capsule, liquid filled, Capsule, liquid filled - Oral, Patch, Topical, Patch - Topical
Pain
, 100.0 mg/mL, 8.33 mg/mL, 50.0 mg/mL, 16.7 mg/mL, 25.0 mg/mL, 33.33 mg/mL, 200.0 mg/mL, 30.0 mg/mL, 20.0 mg, 0.0015 mg/mg, 2.5 mg/pump actuation
, Spray - Buccal, Buccal, Spray, Solution, Solution - Oral, Oral, Sublingual, Oil, Oil - Sublingual, Oil - Oral, Capsule, liquid filled, Capsule, liquid filled - Oral, Patch, Topical, Patch - Topical
Epilepsy
, 100.0 mg/mL, 8.33 mg/mL, 50.0 mg/mL, 16.7 mg/mL, 25.0 mg/mL, 33.33 mg/mL, 200.0 mg/mL, 30.0 mg/mL, 20.0 mg, 0.0015 mg/mg, 2.5 mg/pump actuation
, Spray - Buccal, Buccal, Spray, Solution, Solution - Oral, Oral, Sublingual, Oil, Oil - Sublingual, Oil - Oral, Capsule, liquid filled, Capsule, liquid filled - Oral, Patch, Topical, Patch - Topical
Multiple Sclerosis
, 100.0 mg/mL, 8.33 mg/mL, 50.0 mg/mL, 16.7 mg/mL, 25.0 mg/mL, 33.33 mg/mL, 200.0 mg/mL, 30.0 mg/mL, 20.0 mg, 0.0015 mg/mg, 2.5 mg/pump actuation
, Spray - Buccal, Buccal, Spray, Solution, Solution - Oral, Oral, Sublingual, Oil, Oil - Sublingual, Oil - Oral, Capsule, liquid filled, Capsule, liquid filled - Oral, Patch, Topical, Patch - Topical
Lennox Gastaut Syndrome
, 100.0 mg/mL, 8.33 mg/mL, 50.0 mg/mL, 16.7 mg/mL, 25.0 mg/mL, 33.33 mg/mL, 200.0 mg/mL, 30.0 mg/mL, 20.0 mg, 0.0015 mg/mg, 2.5 mg/pump actuation
, Spray - Buccal, Buccal, Spray, Solution, Solution - Oral, Oral, Sublingual, Oil, Oil - Sublingual, Oil - Oral, Capsule, liquid filled, Capsule, liquid filled - Oral, Patch, Topical, Patch - Topical
Metastatic Cancer
, 100.0 mg/mL, 8.33 mg/mL, 50.0 mg/mL, 16.7 mg/mL, 25.0 mg/mL, 33.33 mg/mL, 200.0 mg/mL, 30.0 mg/mL, 20.0 mg, 0.0015 mg/mg, 2.5 mg/pump actuation
, Spray - Buccal, Buccal, Spray, Solution, Solution - Oral, Oral, Sublingual, Oil, Oil - Sublingual, Oil - Oral, Capsule, liquid filled, Capsule, liquid filled - Oral, Patch, Topical, Patch - Topical
Epilepsies, Myoclonic
, 100.0 mg/mL, 8.33 mg/mL, 50.0 mg/mL, 16.7 mg/mL, 25.0 mg/mL, 33.33 mg/mL, 200.0 mg/mL, 30.0 mg/mL, 20.0 mg, 0.0015 mg/mg, 2.5 mg/pump actuation
, Spray - Buccal, Buccal, Spray, Solution, Solution - Oral, Oral, Sublingual, Oil, Oil - Sublingual, Oil - Oral, Capsule, liquid filled, Capsule, liquid filled - Oral, Patch, Topical, Patch - Topical

Warnings

There are 20 known major drug interactions with Epidiolex.
Common Epidiolex Drug Interactions
Drug Name
Risk Level
Description
Abemaciclib
Major
The metabolism of Abemaciclib can be decreased when combined with Cannabidiol.
Acalabrutinib
Major
The metabolism of Acalabrutinib can be decreased when combined with Cannabidiol.
Acenocoumarol
Major
The metabolism of Acenocoumarol can be decreased when combined with Cannabidiol.
Alectinib
Major
The metabolism of Alectinib can be decreased when combined with Cannabidiol.
Aminophylline
Major
The metabolism of Aminophylline can be decreased when combined with Cannabidiol.
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Epidiolex Novel Uses: Which Conditions Have a Clinical Trial Featuring Epidiolex?

282 active studies are currently in progress to assess the potential of Epidiolex in alleviating Pain, Pain-related Symptoms and Metastatic Cancer.
Condition
Clinical Trials
Trial Phases
Lennox Gastaut Syndrome
2 Actively Recruiting
Phase 1, Phase 2, Phase 4
Epilepsy
19 Actively Recruiting
Not Applicable, Phase 2, Phase 3, Early Phase 1, Phase 4, Phase 1
Tuberous Sclerosis
4 Actively Recruiting
Phase 3, Phase 4, Phase 2, Phase 1
Pain
0 Actively Recruiting
Metastatic Cancer
75 Actively Recruiting
Phase 2, Phase 1, Not Applicable, Early Phase 1, Phase 3
Pain
0 Actively Recruiting
Epilepsies, Myoclonic
7 Actively Recruiting
Phase 3, Phase 2, Phase 4, Phase 1
Multiple Sclerosis
127 Actively Recruiting
Phase 3, Not Applicable, Phase 4, Phase 2, Phase 1, Early Phase 1

Epidiolex Reviews: What are patients saying about Epidiolex?

4.3Patient Review
1/18/2022
Epidiolex for seizures associated with tuberous sclerosis complex
I've been struggling with seizures since 2020. I tried a lot of other medications before this one, and none of them worked well or had such terrible side effects. Epidiolex has really helped me get my seizures under control, and I didn't even see full results until after the 6 month mark.
3.7Patient Review
3/6/2022
Epidiolex for Epilepsy of the Lennox Gastaut Syndrome
Epidiolex has helped me by decreasing the number of absence seizures and clusters I experience. Additionally, it has a calming effect. However, there are some negative side effects to be aware of such as acute euphoric and delusional episodes which could pose dangers. It is unclear if Epidiolex is the direct cause of these issues or if they occur because of interactions with other medications.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about epidiolex

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Epidiolex used for?

"The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy. This medication is meant for patients two years of age and older who suffer from Lennox-Gastaut syndrome or Dravet syndrome."

Answered by AI

Is Epidiolex a CBD?

"The drug EPIDIOLEX is the first and only FDA approved prescription cannabidiol that is able to treat seizures in patients that are one year of age or older that are associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex."

Answered by AI

Is Epidiolex the same as CBD oil?

"Are Epidiolex and CBD the same thing? Epidiolex is the brand name for the pharmaceutical-grade cannabidiol oil product produced by Greenwich, whereas other CBD, “hemp,” and medical marijuana products available may not be as pure and may contain small amounts of THC."

Answered by AI

How does Epidiolex make you feel?

"If you experience any of the following effects for an extended period of time, you should consult your doctor or pharmacist. These effects include drowsiness, tiredness, difficulty sleeping, lack of energy, decreased appetite, weight loss, and diarrhea."

Answered by AI

Clinical Trials for Epidiolex

Image of University of Texas Southwestern Medical Center in Dallas, United States.

Cobenfy KarXT for Memory Loss

18 - 75
All Sexes
Dallas, TX
The goal of this study is to learn about the effects of Cobenfy KarXT (xanomeline and trospium chloride) on episodic memory processing, including specific effects on areas of the brain involved in memory and changes it may have on brain activity. The investigators will do this by testing epileptic patients who are already undergoing intracranial surgery for seizure monitoring, and measuring the activity from the brain areas being assessed. The main questions it aims to answer are 1) whether Cobenfy KarXT changes memory activity based on its agonist effect on muscarinic receptors and acetylcholine, and 2) what the nature of these brain activity changes are. This work builds on previous experiments evaluating cholinergic antagonists. Participants will complete two treatment arms. One of these will be with the drug, and the other will be with a placebo pill, so that the participants are unaware which session the actual drug has been received. Patients will complete a verbal serial recall and/or associative recognition task each of the two days. An anesthesiologist or patient nurse will administer either the drug or the placebo at a critical point which addresses both of the research questions. Researchers will compare the brain activity between the two treatment arms to determine what brain activity changes, and whether there is an additional behavioral effect on memory.
Phase < 1
Waitlist Available
University of Texas Southwestern Medical CenterBradley C Lega, MD
Image of Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo in Buffalo, United States.

Mindset Training for MS

18 - 65
All Sexes
Buffalo, NY
People with Multiple Sclerosis (MS) often experience cognitive difficulties such as memory problems, concentration issues, and reduced processing speed. These symptoms can have a negative impact on daily functioning and overall quality of life. Previous research on cognitive rehabilitation has shown that regular training focused on memory and concentration can have positive effects on cognitive functioning, including processing speed, memory, and executive functions that support daily activities. Moreover, fMRI studies (brain scans that measure brain activity) have revealed changes in brain activation following cognitive rehabilitation. Recently, the idea has emerged that a more personalized approach could improve treatment outcomes. Specifically, researchers have identified a link between personality traits and cognitive functioning. Since every individual is different, current cognitive rehabilitation programs often fail to take these personal differences into account. In this project, the investigators aim to enhance the effectiveness of cognitive rehabilitation by focusing more closely on individual characteristics through an app-based training program. Participants will complete a 12-week app training prior to a 6-week cognitive rehabilitation program. The first app focuses on mindset training, supported by a coach. Afterwards, all participants will use a second app designed to train processing speed and memory. In addition to cognitive functioning, the investigators will also examine psychological, (neuro)biological, and social changes using questionnaires and fMRI. This research may provide valuable insights into how cognitive functioning and quality of life in people with MS can be improved. This study is funded by the National MS Fund and is a collaboration between several institutions: the Department of Health, Medical and Neuropsychology at Leiden University (The Netherlands), the University at Buffalo (USA), and Reha Rheinfelden (Switzerland).
Recruiting
1 Prior Treatment
Jacobs School of Medicine and Biomedical Sciences, Neurology, University at BuffaloHanneke E Hulst, Prof
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Image of Truway Health, Inc. www.truwayhealth.com (401 E 34th Street, S11P, New York, NY 10016) in New York, United States.

Electromagnetic Resonance Therapy for Autoimmune Diseases

Any Age
All Sexes
New York, NY
The ImmuneNet study is a Phase I/II clinical trial sponsored by Truway Health, Inc. It will test whether gentle, low-frequency electromagnetic resonance (LF-EMR) can influence how immune cells communicate and synchronize with each other. The goal is to see if this "quantum-synaptic" signaling effect can help stabilize immune activity and reduce the number of autoimmune flare-ups in people living with conditions such as lupus, rheumatoid arthritis, or multiple sclerosis. Participants will receive either an active or a sham (placebo) LF-EMR session three times per week for twelve weeks. Each session is completely non-invasive. Blood samples will be collected to study cytokines (immune-system messenger molecules), gene-expression patterns, and electrical field coherence among immune cells. A machine-learning system will analyze these data to predict inflammation patterns and guide individualized treatment settings. All participant data will be securely recorded and time-stamped to ensure transparency and privacy. The expected outcome of the study is a measurable reduction in autoimmune flare frequency and symptom severity, along with improved understanding of how electromagnetic signaling might safely regulate immune function.
Phase 1 & 2
Waitlist Available
Truway Health, Inc. www.truwayhealth.com (401 E 34th Street, S11P, New York, NY 10016)Gavin Solomon, President & CEOTruway Health, Inc.
Image of John D. Dingell VA Medical Center in Detroit, United States.

Ocrelizumab for Multiple Sclerosis

18 - 75
All Sexes
Detroit, MI
This study seeks to assess the effects of long-term ocrelizumab therapy on fatigue (extreme tiredness) as well as cognition (thinking and reasoning skills, such as memory, learning and attention), in veterans with multiple sclerosis. The evaluation will involve cognitive assessment scales (to assess memory, attention and learning abilities), clinical evaluations (to assess nerve function and ability to move), and patient-reported outcome measures (in which you will answer questions about your tiredness, sleep and how you function in daily life). These assessments will occur at baseline (visit 1), 6 month (Visit-2) and 12 months (visit 3) to track changes over time.
Waitlist Available
Has No Placebo
John D. Dingell VA Medical CenterGenentech, Inc.
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Image of Disability Participation and Quality of Life (DPQOL) Laboratory in Urbana, United States.

Fall Prevention Program for Multiple Sclerosis

18+
All Sexes
Urbana, IL
The research team is conducting a study to determine if a fall prevention program designed specifically for people who use wheelchairs and scooters can help people better prevent and manage falls compared to the standard of care. This study will compare two groups of participants: 1. One group will use the iROLL-O+ app, which offers personalized fall prevention tools and strategies. 2. The other group will receive fall prevention information from a well-known program developed by the Centers for Disease Control and Prevention (CDC), called STEADI, which stands for Stopping Elderly Accidents, Deaths, and Injuries. This study includes adults living with Spinal Cord Injury (SCI) or Multiple Sclerosis (MS) who use a wheelchair or scooter every day. The research team aims to determine which approach is more effective in reducing falls and improving confidence in performing daily activities.
Waitlist Available
Has No Placebo
Disability Participation and Quality of Life (DPQOL) Laboratory
Have you considered Epidiolex clinical trials? We made a collection of clinical trials featuring Epidiolex, we think they might fit your search criteria.Go to Trials
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