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Carbamazepine (Ph. Eur.)

This article discusses the use of Carbamazepine (Ph. Eur.), an anticonvulsant medication, in clinical trials for patients with chronic pain due to diabetic polyneuropathy. The study aims to evaluate the effectiveness and safety of this drug as part of a combination treatment for managing neuropathic pain in diabetes patients.

Table of Contents

What is Carbamazepine?

Carbamazepine, also known by its pharmaceutical name CARBAMAZEPINE (PH. EUR.), is a medication primarily used as an anticonvulsant[1]. It belongs to a class of drugs that work on the nervous system to control seizures and manage certain types of pain. In the context of the clinical trial discussed here, carbamazepine is being studied for its potential in treating chronic pain associated with diabetic neuropathy.

Uses of Carbamazepine

While carbamazepine is traditionally used to treat epilepsy and certain psychiatric conditions, this clinical trial is exploring its effectiveness in managing chronic pain due to diabetic polyneuropathy[1]. Diabetic polyneuropathy is a complication of diabetes that causes nerve damage, leading to chronic pain in various parts of the body, particularly the extremities.

Dosage and Administration

According to the clinical trial information, carbamazepine is administered orally[1]. The maximum daily dose mentioned in the study is 120 mg, with a maximum total dose amount of 201,600 mg over the course of the treatment[1]. The maximum treatment period is set at 60 weeks, which is equivalent to about 14 months[1].

Clinical Trial Information

The clinical trial (number 2022-500897-32-00) is a Phase III study, which means it is in an advanced stage of testing the effectiveness and safety of carbamazepine for chronic pain due to diabetic polyneuropathy[1]. The study aims to evaluate the efficacy of a treatment called AP707, which includes carbamazepine, as an add-on treatment for patients with this condition.

Eligibility Criteria

To participate in this study, patients must meet certain criteria. Some key inclusion criteria are:

  • Adults (18 years or older) with chronic pain due to diabetic polyneuropathy for at least 3 months[1]
  • Moderate to severe pain (score of 5 or higher on a 0-10 scale)[1]
  • Life expectancy of more than 1 year[1]

Some exclusion criteria include:

  • History of severe cardiovascular disease[1]
  • Severe mental illness or history of addictive disease[1]
  • Severe liver or kidney diseases[1]

Potential Benefits

The study aims to assess several potential benefits of the treatment, including:

  • Reduction in pain levels[1]
  • Improvement in quality of life[1]
  • Better sleep quality[1]
  • Reduced psychological distress[1]

Safety Considerations

As with any medication, there are potential risks and side effects associated with carbamazepine. The study will closely monitor participants for any adverse events[1]. Patients with a history of hypersensitivity or intolerance to the drug or its ingredients are excluded from the study to minimize risks[1].

It’s important to note that this information is based on an ongoing clinical trial, and the full effectiveness and safety profile of carbamazepine for chronic pain in diabetic neuropathy is still being evaluated. Patients should always consult with their healthcare provider before considering any new treatment options.

Aspect Details
Study Type Phase III clinical trial (therapeutic exploratory and confirmatory)
Main Objective Evaluate efficacy of AP707 (including Carbamazepine) as add-on treatment for chronic pain in diabetic polyneuropathy
Secondary Objective Evaluate safety and tolerability of the treatment
Key Inclusion Criteria Adults (≥18 years) with chronic diabetic neuropathy pain for ≥3 months, pain intensity ≥5 on NRS
Key Exclusion Criteria History of severe cardiovascular disease, mental illness, or addictive disease
Primary Endpoint Change in pain level (NRS) between baseline and week 14
Secondary Endpoints Changes in pain levels, quality of life, sleep quality, psychological distress at various time points
Carbamazepine Details Maximum daily dose: 120 mg, Maximum total dose: 201,600 mg, Treatment period: up to 60 weeks

FAQ

  • What is the main purpose of the clinical trial using Carbamazepine? The main purpose is to evaluate the effectiveness of a combination treatment that includes Carbamazepine for patients with chronic pain due to diabetic polyneuropathy.
  • Who can participate in this clinical trial? Participants must be adults (18 years or older) with chronic pain due to diabetic polyneuropathy for at least 3 months, have moderate to severe pain, and meet other specific criteria set by the researchers.
  • How long does the clinical trial last? The trial lasts for 52 weeks (about one year), with evaluations at different time points, including weeks 14, 26, and 52.
  • What is being measured in this clinical trial? The trial measures changes in pain levels using various scales and questionnaires, as well as changes in quality of life, sleep quality, and psychological distress. It also monitors the safety and tolerability of the treatment.
  • Is Carbamazepine the only medication being studied in this trial? No, Carbamazepine is part of a combination treatment being studied. The trial also mentions other components like AP707, amitriptyline, and capsaicin, although the full details of the combination are not provided in the given information.

Ongoing Clinical Trials on Carbamazepine (Ph. Eur.)

  • Study on the Effectiveness and Safety of AP707, Amitriptyline, and Capsaicin for Patients with Chronic Pain from Diabetic Neuropathy

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany

Glossary

  • Carbamazepine (Ph. Eur.): An anticonvulsant medication used to treat various conditions, including epilepsy and neuropathic pain. In this trial, it's being studied as part of a combination treatment for diabetic neuropathy pain.
  • Diabetic polyneuropathy: A type of nerve damage that can occur in people with diabetes, often causing pain, tingling, or numbness in the hands and feet.
  • Numeric Rating Scale (NRS): A pain measurement tool where patients rate their pain intensity on a scale from 0 (no pain) to 10 (worst possible pain).
  • Neuropathic Pain Symptom Inventory (NPSI): A questionnaire used to assess different aspects of neuropathic pain.
  • Patient Global Impression of Change (PGIC): A scale used to measure a patient's overall assessment of their condition since starting treatment.
  • Quality of life: A measure of a person's overall well-being and satisfaction with life, often assessed in clinical trials to determine how treatments affect patients' daily lives.
  • Adverse events (AE): Any unfavorable or unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it's related to the treatment being studied.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-ap707-amitriptyline-and-capsaicin-for-patients-with-chronic-pain-from-diabetic-neuropathy/