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Cbd oil treatment for als

Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease

This is a randomised, double-blind, placebo controlled study on a cannabis-based medicine extract (MediCabilis CBD Oil), in patients with Amyotrophic Lateral Sclerosis or Motor Neurone Disease. Participants will be randomised in a 1:1 ratio to receive MediCabilis CBD Oil or placebo oil. The treatment duration is 6 months with one-month safety follow up. Participants will be checked every month either face to face or via telephone and will be assessed to collect data for study objectives such as ALSFRS-R, Forced Vital Capacity, pain and spasticity score, and quality of life. Thirty (30) participants will be randomised.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Motor Neuron Disease Drug: MediCabilis CBD Oil Drug: Placebo Oil Phase 3

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Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Single-centre Study on the Safety, Tolerability and Efficacy of Cannabis Based Medicine Extract (MediCabilis CBD Oil) in Slowing the Disease Progression in Amyotrophic Lateral Sclerosis or Motor Neurone Disease Patients
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : January 30, 2023
    Difference in mean ALS Functional Rating Scale-Revised (ALSFRS-R) total score between groups at end of treatment (Total score: min 0- max 48) [efficacy] [ Time Frame: Baseline to Day 180 ]

Change from baseline in ALS functional rating total scores on the ALSFRS-R at 24 weeks. Total score ranges from 0 to 48. Higher value represents better outcome.

    Nature and number of adverse events [safety and tolerability] [ Time Frame: Baseline to Day 180 ]

Change from baseline in spasticity total score on the Numeric Rating Scale for spasticity at 24 weeks. Total score ranges from 0 to 100. Higher values represent better outcome.

Change from baseline in pain total score on the Numeric Rating Scale for pain at 24 weeks. Total score ranges from 0 to 100. Higher value represents better outcome.

Change from baseline in weight loss on the Percentage of Total Weight Loss at 24 weeks. Percentage ranges from 0 to 100. Higher value represents better outcome.

Change from baseline in quality of life total score on the ALS Specific Quality of Life- Revised (ALSSQOL-R) score at 24 weeks. Total score ranges from 0 to 460. Higher score represent better outcome.

  1. Difference in mean Edinburgh Cognitive and Behavioural ALS Screen (ECAS) total score between groups at end of treatment (Score 0-136) [ Time Frame: Baseline to Day 180 ]

Change from baseline in quality of life total score on the ALS Specific Quality of Life- Revised (ALSSQOL-R) total score at 24 weeks. Total score ranges from 0 to 100. Higher score represent better outcome.

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.

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Ages Eligible for Study: 25 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
  1. Affected by ALS/MND, either of definite or probable according to the El Escorial revised criteria
  2. Can provide written informed consent
  3. Able and willing to comply with all study requirement
  4. Male or female, ages 25-80 years old
  5. Onset of first symptom within the last 2 years
  6. Forced Vital Capacity (FVC) of at least 60% on baseline
  1. Participants who are bedridden
  2. Have used or taken cannabis or cannabinoid-based medications within 30 days of study entry
  3. History of any psychiatric disorder other than depression associated with their underlying condition including immediate family history of schizophrenia
  4. Heavy consumption of alcohol or use of illicit drug
  5. Hypersensitivity to cannabinoids or any of the excipients
  6. Any of the following: eGFR 5 X ULN
  7. Unwillingness of a female participant of child bearing potential, or their partner, to use effective contraception during the study and 30 days thereafter
  8. Pregnant, lactating mother or female participant planning pregnancy during the course of the study and for 30 days thereafter
  9. Received any investigational drug or medical device within 30 days prior randomisation
  10. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study
  11. Inability to cooperate with the study procedures
  12. Unwilling to stop driving vehicle or operating dangerous machinery whilst on study drug.
  13. Close affiliation with the study team, e.g. close relative of the investigator
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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): NCT03690791

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Contact: Arman Sabet, MD +61 1300 744 284 [email protected]
Contact: Berzenn Urbi, RN +61 1300 744 284 [email protected]
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Australia, Queensland
Gold Coast Hospital and Health Service Recruiting
Gold Coast, Queensland, Australia, 4215
Contact: Arman Sabet, MD +61 1300 744 284 [email protected]

This study will comply with the Australian Government Data Sharing Policy, the NHMRC Open Access Policy and the Clinical Trials Registration and Results Information Submission rule.

Additional data can be requested from the authors. However, the decision to disclose data is solely based from authors’ discretion and funding agency.

CBD Oil for ALS (Lou Gehrig’s Disease)

ALS, also known as Lou Gehrig’s disease, is a degenerative disorder. Researchers named this disorder after the famous baseball legend Lou Gehrig, who was the first to be formally diagnosed with the condition. Characteristics of this disorder include gradually worsening muscle control and strength, which can eventually involve the inability to speak or swallow.

Most modern treatments for ALS focus on palliative care rather than curative solutions. Medical experts help patients to deal with chronic pain and discomfort, while also striving to extend life expectancy.

However, new research concerning ALS is underway. In recent years, there has been a focus on using cannabinoids, such as cannabidiol, to address ALS’s symptoms. This article addresses burgeoning research regarding possible uses of CBD in managing ALS symptoms. Various ways in which ALS can affect patients will also be discussed and examined.

What Is ALS?

ALS, or Amyotrophic Lateral Sclerosis, is a degenerative disease that causes the muscles in the body to weaken and atrophy. This makes it challenging to move the limbs, but it also adversely affects many functions within the body, including respiration and swallowing. With no known cure, ALS eventually leads to death by respiratory failure, as the body becomes incapable of even breathing properly without aid.

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Common ALS Treatment Options

Unfortunately, despite the best efforts of scientists everywhere, there are currently no useful medical treatments that work to prevent or treat ALS. Instead, most medical professionals attempt to delay the onset of worsening symptoms.

Doctors often recommend ALS support group plans that work to improve the mental health of sufferers. It is also beneficial for patients as they can connect to others with the same diagnosis.

Since its approval in 1995, Riluzole, under the brand name Rilutek, has been the primary ALS treatment option. The drug works to slow the progression of ALS, all while prolonging the sufferer’s life expectancy after diagnosis.

The main problem is that these drugs are prohibitively expensive, at least in the USA, and they also tend to create extremely unpleasant side effects.

For example, patients commonly report excessive nausea, stomach pain, and general flu-like symptoms after regularly taking Riluzole, forcing them to choose between long-term health and short term pain.

However, CBD may address the side effects of drugs such as Riluzole, allowing patients to have less stress and discomfort. CBD may assist in making patients’ lives easier, allowing doctors and specialists to concentrate on long-range options and care.

What Is CBD & What Can It Do?

CBD is a chemical compound that works with the body to produce a variety of beneficial effects, many of which can mitigate symptoms.

It works because the body already has an endocannabinoid system (ECS), a health system designed to work with cannabinoids naturally. It is responsible for many different responses within the body, such as the release of helpful neurochemicals and even the body’s inflammatory response.

Most conditions that CBD may mitigate are related to these bodily responses – a reduction in anxiety as a result of interaction with the serotonin receptor, or controlling the pain of arthritis by helping diminish the inflammation. These are just two widespread uses of CBD.

What Do the Studies Say?

Over the years, more and more researchers have conducted studies to show CBD’s efficacy as a way to help those with ALS.

One example is a report by Sabrina Giacoppo and Emanuela Mazzon for the Journal of Neural Regenerative Research. It investigated the effects of various cannabinoid compounds on ALS progression and mortality.

The researchers found that delta-9-tetrahydrocannabinol (THC), cannabinol (CBN), Sativex (a 1:1 mixture of THC and CBD), and other compounds had positive effects. They included reducing oxidative stress, protecting the nervous system, and slowing disease progression.

Most of these findings were based on animal studies, meaning further research is warranted. However, the authors concluded: “…there is a valid rationale to propose the use of cannabinoid compounds in the pharmacological management of ALS patients. Cannabinoids indeed are able to delay ALS progression and prolong survival.”

Despite the lack of human clinical trials, a case report by Gerhard Nahler discussed the effects of co-medication with cannabidiol on ALS symptoms.

Co-medication works by pairing CBD with another conventionally used drug, as certain medications seem to work together and produce an increased efficacy rate. Experts observe this in those who have epilepsy, where they note a reduction in seizures when patients take a mixture of CBD and the conventional epilepsy drug, Clobazam.

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The report demonstrated that CBD and Riluzole delayed the progression of the disease in a patient recently diagnosed with ALS. It improved symptoms such as muscle weakness and difficulties with speech and swallowing for approximately 12 months.

Finally, a 2019 study investigated the effects of CBD with THC on spasticity in 32 ALS patients. It found that there was a high level of satisfaction with the treatment, especially among those with moderate to severe symptoms. The researchers state that “THC:CBD may serve as a valuable addition in the spectrum of symptomatic therapy in ALS.” However, they also suggest that further research is necessary.

So Is CBD Oil Only Useful as a Co-Medication?

All this might lead some to believe that the only use CBD oil has is in conjunction with conventional drugs used to treat ALS.

However, while CBD oil can be useful when combined with other drugs, the fact remains that those taking CBD oil still enjoy the various potential benefits that this unique oil would provide. For example, CBD users have stated that this substance reduces stress, increases relaxation, and eases pain, and it is known to have pain-relieving and anti-anxiety properties.

Another potential benefit of CBD for ALS patients is its ability to regulate the immune system and quell inflammation. Experts have suggested that immune dysfunction may contribute to the development of ALS and research has shown that people with the condition often have excessive levels of inflammation.

Although there is currently no evidence that CBD can reduce inflammation in ALS, specifically, it may well have positive effects. While CBD seems to be a worthwhile option, some might be wondering why patients use CBD oil rather than whole-plant, medical marijuana. , In fact, there are a few reasons why some experts don’t recommend regular cannabis for treating ALS.

Why Not Just Smoke Regular Marijuana?

While there are many people who smoke cannabis regularly to manage many of the underlying symptoms of ALS, there are a few significant drawbacks that make taking CBD oil a preferable option.

For starters, THC’s psychogenic effects can potentially be a problem for those with ALS. While some people may find the high pleasant, others may not enjoy the sensation. Furthermore, THC can cause various side effects, including dizziness, confusion, or increased anxiety levels.

Furthermore, marijuana sales are not currently allowed in a variety of jurisdictions in the USA, making it all the more difficult for doctors to recommend it as a useful option to assist with ALS symptoms.

There is also a more practical issue with smoking cannabis – the ability to smoke it at all. As ALS develops, the ability to breathe independently can be impaired, making it challenging to attempt to smoke marijuana. This is often one of the main reasons why CBD oil is preferable, as it is far easier to take for someone with reduced motility.

Final Verdict About CBD Oil for ALS

ALS patients may now use CBD oil to mitigate or reduce their symptoms as it is readily available in many places. Studies show that there is great promise in how people can benefit from CBD.

Although there is still plenty of research to be done, CBD oil seems to be a compelling choice for those looking to lessen the effects of many ALS symptoms.