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Study on the Effects of THC and CBD Oral Solution for Chronic Neuropathic Pain in Multiple Sclerosis Patients

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for people with multiple sclerosis (MS) who experience chronic neuropathic pain. The treatment being tested is an oral solution called Satalliv, which contains two active substances: Delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). These substances are known for their potential to relieve pain and improve comfort in patients with certain conditions.

The purpose of the study is to evaluate how effective, safe, and tolerable this oral solution is for relieving chronic neuropathic pain in MS patients. Participants in the study will receive either the THC:CBD oral solution or a matching placebo. The study will last for a total of 12 weeks, with the main focus on the first 4 weeks of treatment. During this time, participants will be monitored to see how their pain levels change and to ensure their safety while using the treatment.

Throughout the study, participants will have regular check-ups to assess their pain levels and overall health. The study aims to determine if the THC:CBD solution can significantly reduce pain and improve the quality of life for those living with MS-related chronic neuropathic pain. The results will help researchers understand the potential benefits of this treatment for managing pain in MS patients.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the **THC:CBD oral solution** or a **placebo**. This is a double-blind study, meaning neither you nor the researchers will know which treatment you are receiving to ensure unbiased results.

2 initial assessment

You will undergo an initial assessment to establish a baseline for your current health status. This includes measuring your pain levels using a scale from 0 to 10, where 0 means no pain and 10 means the worst possible pain.

3 treatment phase

You will begin taking the assigned oral solution. The dosage is **25 mg of THC and 25 mg of CBD per milliliter**. The frequency and duration of administration will be explained to you by the study team.

You will continue this treatment for a period of **4 weeks**. During this time, you are required to maintain your current medication regimen and avoid driving motorized vehicles.

4 mid-study evaluation

After 4 weeks, your pain levels and other health indicators will be reassessed. This includes another measurement of your pain using the same 0 to 10 scale.

The study team will evaluate any changes in your condition and monitor for any side effects or adverse events.

5 extended treatment phase

If you continue in the study, the treatment will be extended for an additional **8 weeks**, making a total of **12 weeks** of treatment.

You will continue to take the oral solution as previously instructed and maintain your current medication regimen.

6 final assessment

At the end of the 12-week period, a final assessment will be conducted. This will include a comprehensive evaluation of your pain levels, overall health, and any changes in your condition.

The study team will also review any side effects or adverse events that may have occurred during the study.

7 follow-up

A follow-up will be scheduled to ensure your well-being after the study concludes. This may include additional health assessments and discussions about your experience during the trial.

Who Can Join the Study?

  • Must be a native Portuguese speaker and have given written consent to participate in the study.
  • Must have been on a stable dose of Disease Modifying Therapies (DMTs) for at least 6 months and be willing to continue this treatment during the study.
  • Must have been on a stable regimen of other medications and non-drug therapies for at least 4 weeks before the study and be willing to continue these during the study.
  • Female participants must either be unable to have children or agree to use a highly effective birth control method during the study and for 3 months after the last dose of the study medication. If using hormonal birth control, a barrier method like a condom should also be used.
  • Male participants who are sexually active with a female partner who can have children must use a condom during the study and for 3 months after the last dose of the study medication.
  • Male participants must ensure their female partners use a highly effective birth control method during the same period.
  • Male participants must agree not to donate sperm during the study and for 3 months after the last dose of the study medication.
  • Must be willing to follow all study procedures and restrictions, including not driving motorized vehicles during the study and follow-up period.
  • Must be between 18 to 65 years old at the time of signing the consent form.
  • Must not have any significant abnormalities in vital signs, heart tests (12-lead ECG), or laboratory tests.
  • Must have been diagnosed with multiple sclerosis (MS) for more than 6 months, according to specific criteria, and can have any type of MS.
  • Must have had chronic neuropathic pain due to MS for at least 6 months.
  • Must have tried at least one medication for chronic neuropathic pain that did not work or was not tolerated.

Who Cannot Join the Study?

  • Patients who do not have chronic neuropathic pain due to multiple sclerosis (MS) cannot participate. Chronic neuropathic pain is a type of pain caused by nerve damage, and multiple sclerosis is a disease that affects the brain and spinal cord.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to adults.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who have any other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have a history of substance abuse or dependency cannot participate.
  • Patients who have allergies or adverse reactions to the study medication cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
CCAB Centro Clinico Academico Braga Associacao Braga Portugal

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Portugal Portugal
Recruiting
13.05.2025

Trial locations

Investigated drugs:

THC/CBD Oral Solution is a liquid medication that combines two active ingredients: THC and CBD. These are compounds found in the cannabis plant. In this trial, the solution is being tested to see if it can help reduce chronic nerve pain in people with multiple sclerosis. The goal is to find out if this combination can provide pain relief and improve comfort for patients over a period of four weeks. THC is known for its ability to create a feeling of relaxation, while CBD is often used for its potential to reduce pain and inflammation without causing a high. Together, they may offer a balanced approach to managing pain.

Investigated diseases:

Chronic Neuropathic Pain due to Multiple Sclerosis – Chronic neuropathic pain in multiple sclerosis is a persistent pain condition resulting from nerve damage associated with multiple sclerosis. It is characterized by sensations such as burning, tingling, or shooting pain, often affecting the limbs or trunk. This pain can fluctuate in intensity and may be triggered by movement or touch. Over time, the pain can become more constant and may interfere with daily activities and sleep. The progression of this pain is linked to the underlying progression of multiple sclerosis, which involves the immune system attacking the protective covering of nerves. As the disease progresses, the nerve damage can lead to increased pain and other neurological symptoms.

Trial ID:
2024-520287-34-01
Protocol code:
BLCL-THC/CBD-01
Trial Phase:
Therapeutic exploratory (Phase II)

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