In short
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.
At a glance
- 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
What is Carbamazepine?
Carbamazepine, also known by its pharmaceutical name CARBAMAZEPINE (PH. EUR.), is a medication primarily used as an anticonvulsant. 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. 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. 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. The maximum treatment period is set at 60 weeks, which is equivalent to about 14 months.
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. 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
- Moderate to severe pain (score of 5 or higher on a 0-10 scale)
- Life expectancy of more than 1 year
Some exclusion criteria include:
- History of severe cardiovascular disease
- Severe mental illness or history of addictive disease
- Severe liver or kidney diseases
Potential Benefits
The study aims to assess several potential benefits of the treatment, including:
- Reduction in pain levels
- Improvement in quality of life
- Better sleep quality
- Reduced psychological distress
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. Patients with a history of hypersensitivity or intolerance to the drug or its ingredients are excluded from the study to minimize risks.
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.