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Anhydrous Cholestyramine

Anhydrous Cholestyramine, a bile acid sequestrant, is being investigated in clinical trials for its potential role in treating multiple sclerosis (MS). These trials aim to evaluate the long-term safety, tolerability, and efficacy of tolebrutinib, a primary drug under study, in patients with various forms of MS. Anhydrous Cholestyramine is included as a secondary medication in these trials, possibly to manage side effects or complement the main treatment. The studies focus on different types of MS, including relapsing, primary progressive, and secondary progressive forms.

Table of Contents

What is Anhydrous Cholestyramine?

Anhydrous Cholestyramine, also known by its brand name Colestyramine, is a medication classified as a bile acid sequestrant[1]. This means it works by binding to bile acids in your intestines, which helps remove them from your body. Bile acids are produced by your liver and play a role in digesting fats.

Medical Uses

While the primary focus of the clinical trials mentioned in the source material is on multiple sclerosis, it’s important to note that Anhydrous Cholestyramine has several established uses in medicine:

  • Lowering Cholesterol: It’s primarily used to reduce high levels of cholesterol in the blood, particularly LDL (low-density lipoprotein) cholesterol, often referred to as “bad” cholesterol[1].
  • Treating Itching Associated with Liver Disease: It can help relieve itching caused by partial biliary obstruction (a condition where bile flow from the liver is partially blocked).
  • Managing Diarrhea: In some cases, it’s used to treat certain types of diarrhea, particularly those caused by bile acid malabsorption.

In the context of the clinical trials mentioned, Anhydrous Cholestyramine is being studied as part of a broader investigation into treatments for multiple sclerosis (MS). However, it’s important to note that the drug’s role in these trials is not explicitly stated, and it may be used as a comparator or for managing side effects of other treatments[2].

How is it Administered?

Anhydrous Cholestyramine is typically taken orally (by mouth)[1]. It often comes in a powder form that needs to be mixed with water or other liquids before consumption. The exact dosage and frequency of administration would be determined by your healthcare provider based on your specific medical condition and response to treatment.

Current Clinical Trials

The clinical trials mentioned in the source material are primarily focused on investigating a drug called tolebrutinib for multiple sclerosis. Anhydrous Cholestyramine is listed as a secondary medication in these trials, but its specific role is not detailed[2]. These trials are:

  • Phase 3 extension studies to investigate the long-term safety and tolerability of tolebrutinib in participants with various forms of multiple sclerosis, including relapsing multiple sclerosis (RMS), primary progressive multiple sclerosis (PPMS), and non-relapsing secondary progressive multiple sclerosis (NRSPMS).
  • The studies aim to assess the long-term efficacy of tolebrutinib on disability progression, relapse rate, and magnetic resonance imaging (MRI) parameters in participants with these forms of MS.

While Anhydrous Cholestyramine is mentioned in these trials, its specific role and any potential benefits for MS patients are not explicitly stated in the provided information[2].

Potential Side Effects and Precautions

As with any medication, Anhydrous Cholestyramine can cause side effects. Some potential side effects and precautions to be aware of include:

  • Gastrointestinal Issues: Constipation is a common side effect. Less common side effects may include nausea, bloating, or abdominal discomfort.
  • Vitamin Deficiencies: Long-term use may lead to deficiencies in fat-soluble vitamins (A, D, E, K) as the medication can interfere with their absorption.
  • Drug Interactions: Anhydrous Cholestyramine can interact with other medications, potentially reducing their effectiveness. It’s important to take other medications at least 1 hour before or 4-6 hours after taking cholestyramine.
  • Liver Function: The clinical trials mention exclusion criteria related to liver function, suggesting that individuals with certain liver conditions may need to use this medication with caution[2].

It’s crucial to discuss any potential side effects or concerns with your healthcare provider. They can provide personalized advice based on your specific medical history and current health status.

Aspect Details
Study Type Phase 3 extension study
Primary Drug Tolebrutinib
Secondary Drug Anhydrous Cholestyramine
Conditions Studied Relapsing Multiple Sclerosis (RMS), Primary Progressive Multiple Sclerosis (PPMS), Non-relapsing Secondary Progressive Multiple Sclerosis (NRSPMS)
Main Objectives Long-term safety and tolerability of tolebrutinib
Secondary Objectives Efficacy on disability progression, relapse rate, and MRI parameters
Key Inclusion Criteria Completion of previous Phase 2b or Phase 3 tolebrutinib trials
Key Exclusion Criteria Chronic infections, prohibited treatments, liver conditions, alcohol use disorder, abnormal ECG, bleeding disorders
Primary Endpoints Number of participants with adverse events, serious adverse events, and events leading to discontinuation
Secondary Endpoints Time to disability worsening/progression, annualized relapse rate, changes in MRI lesions

FAQ

  • What is Anhydrous Cholestyramine and how is it being used in these clinical trials? Anhydrous Cholestyramine is a bile acid sequestrant. In these trials, it is included as a secondary medication alongside tolebrutinib, the primary drug being studied for multiple sclerosis treatment. Its exact role is not specified, but it may be used to manage side effects or complement the main treatment.
  • What types of multiple sclerosis are being studied in these trials? The trials are investigating the effects of treatment on various forms of multiple sclerosis, including relapsing multiple sclerosis (RMS), primary progressive multiple sclerosis (PPMS), and non-relapsing secondary progressive multiple sclerosis (NRSPMS).
  • What are the main objectives of these clinical trials? The main objectives are to determine the long-term safety and tolerability of tolebrutinib in participants with relapsing and progressive forms of multiple sclerosis. Secondary objectives include assessing long-term efficacy on disability progression, relapse rate, and magnetic resonance imaging (MRI) parameters.
  • Who is eligible to participate in these trials? Eligible participants are those who have completed previous Phase 2b or Phase 3 tolebrutinib trials for multiple sclerosis. This includes participants who may have temporarily discontinued the investigational medicinal product due to a national emergency but completed the trial visits.
  • What are some of the key exclusion criteria for these trials? Key exclusion criteria include having persistent chronic or recurring systemic infections, receiving treatments not permitted by the study protocol, having certain liver conditions, active alcohol use disorder, abnormal ECG results, bleeding disorders, and other clinically relevant systemic diseases that could interfere with the study or put the participant at risk.

Ongoing Clinical Trials on Anhydrous Cholestyramine

  • Study on Long-Term Safety of Tolebrutinib and Teriflunomide for Patients with Multiple Sclerosis

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia Denmark +17

  • Study on Long-Term Safety of Tolebrutinib for Patients with Relapsing or Progressive Multiple Sclerosis

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark The Netherlands

Glossary

  • Anhydrous Cholestyramine: A bile acid sequestrant medication that is being investigated as a secondary treatment in multiple sclerosis clinical trials.
  • Multiple Sclerosis (MS): A chronic disease affecting the central nervous system, where the immune system attacks the protective covering of nerves.
  • Tolebrutinib: The primary investigational drug being studied in these clinical trials for the treatment of multiple sclerosis.
  • Relapsing Multiple Sclerosis (RMS): A form of MS characterized by clearly defined attacks of new or increasing neurologic symptoms, followed by periods of partial or complete recovery.
  • Primary Progressive Multiple Sclerosis (PPMS): A type of MS where symptoms steadily worsen from the onset of the disease, without early relapses or remissions.
  • Non-relapsing Secondary Progressive Multiple Sclerosis (NRSPMS): A stage of MS that follows relapsing-remitting MS, where the disease steadily worsens without distinct relapses.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious Adverse Events (SAEs): Adverse events that result in death, are life-threatening, require hospitalization, cause persistent or significant disability, or lead to birth defects.
  • Confirmed Disability Worsening (CDW): A measure used in MS clinical trials to assess the progression of disability over time.
  • Annualized Relapse Rate (ARR): The average number of relapses a patient with MS experiences per year.
  • T2-hyperintense lesions: Areas of damage in the brain or spinal cord visible on MRI scans, indicative of MS activity.

References

  1. http://clinicaltrials.eu/trial/study-on-long-term-safety-of-tolebrutinib-for-patients-with-relapsing-or-progressive-multiple-sclerosis/
  2. http://clinicaltrials.eu/trial/study-on-long-term-safety-of-tolebrutinib-and-teriflunomide-for-patients-with-multiple-sclerosis/