In short
This article discusses the use of Benserazide Hydrochloride, a component of Madopark tablets, in clinical trials for Parkinson's disease treatment. While the main focus of the trial is on Montelukast, Madopark (containing Benserazide Hydrochloride and Levodopa) is used as a background therapy. The study aims to examine the effects of Montelukast on disease progression and symptoms in patients with mild to moderate Parkinson's disease.
At a glance
- Trial Name
- MONTPARK: Montelukast as disease-modifying treatment in mild-moderate Parkinson's disease
- Trial Phase
- Phase II
- Main Objective
- Examine the effect of Montelukast on disease progression in early to moderate Parkinson's disease
- Background Therapy
- Madopark (Benserazide Hydrochloride + Levodopa)
- Madopark Administration
- Oral, maximum daily dose 1800 mg, treatment duration up to 24 months
- Primary Outcome Measure
- MDS-UPDRS Part 3 (motor symptoms) in OFF-medication state
- Secondary Outcome Measures
- MDS-NMS, HADS, adverse events, LEDD score
- Key Inclusion Criteria
- Age 35-80, PD diagnosis <4 years, H&Y stage ≤2 in OFF, ongoing levodopa treatment
- Key Exclusion Criteria
- Severe depression, dementia, atypical parkinsonism, active hepatitis B or C
What is Benserazide Hydrochloride?
Benserazide Hydrochloride is a medication commonly used in the treatment of Parkinson's disease. It belongs to a class of drugs known as decarboxylase inhibitors. While Benserazide itself doesn't directly treat Parkinson's symptoms, it plays a crucial role in enhancing the effectiveness of another important medication called Levodopa.
Combination with Levodopa
Benserazide Hydrochloride is typically combined with Levodopa in a single tablet. This combination is known by various brand names, including Madopark. The specific formulation mentioned in the clinical trial data is "Madopark 100 mg/25 mg tablets," which contains 100 mg of Levodopa and 25 mg of Benserazide Hydrochloride.
The reason for this combination is that Benserazide helps prevent the breakdown of Levodopa before it reaches the brain. This allows more Levodopa to cross the blood-brain barrier, increasing its effectiveness in treating Parkinson's symptoms.
Medical Conditions Treated
The primary condition treated by the Benserazide-Levodopa combination is Parkinson's disease. Parkinson's is a progressive nervous system disorder that affects movement. Symptoms may include tremors, stiffness, and difficulty with balance and coordination.
This medication is particularly useful for patients with: Early to moderate Parkinson's disease: The clinical trial data suggests it's used in patients with a clinical diagnosis of less than 4 years and a Hoehn and Yahr stage (a measure of Parkinson's progression) of 2 or less. Motor symptoms: The primary goal of treatment is to improve motor symptoms, which are measured using a scale called the MDS-UPDRS Part 3. Non-motor symptoms: The medication may also help with non-motor symptoms of Parkinson's disease.
Dosage and Administration
According to the clinical trial data: The medication is taken orally in tablet form. The maximum daily dose is 1800 mg. The maximum total dose over the course of treatment is 1,314,000 mg. The maximum treatment period is 24 months.
It's important to note that these are maximum doses, and your doctor will prescribe the appropriate dose for your specific condition. Always follow your doctor's instructions regarding dosage and administration.
Eligibility Criteria for Treatment
Based on the clinical trial information, the following criteria are considered for treatment eligibility: Inclusion Criteria: Age between 35 and 80 years Clinical diagnosis of Parkinson's disease for less than 4 years Hoehn and Yahr stage 2 or less in the OFF medication state (This scale measures the progression of Parkinson's disease) Already on ongoing levodopa treatment Ability to self-administer the medication Exclusion Criteria: Previous or concurrent depression requiring hospitalization Severe liver or kidney disease Concurrent moderate-to-severe depression Concurrent dementia Active oral mucosa inflammation Active Hepatitis B or C infection Atypical or other causes of parkinsonism Prior intra-cerebral surgical intervention
It's crucial to discuss your full medical history with your doctor to determine if this medication is appropriate for you.
Potential Side Effects and Monitoring
While the clinical trial data doesn't provide specific information about side effects of Benserazide Hydrochloride, it does mention that the study will examine: The frequency of adverse events in patients taking the medication compared to those on placebo Changes in vital signs Changes in clinical laboratory values
Your doctor will monitor these aspects during your treatment. It's important to report any unusual symptoms or side effects to your healthcare provider promptly.