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临床试验/NCT06115538
NCT06115538Unknown4 期

Comparison of Blood Dopamine Levels in Idiopathic Parkinson's Patients Receiving Levodopa Carbidopa Entacapone or Levodopa Benserazide

Ankara Ataturk Sanatorium Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 96 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
96
试验地点
2
主要终点
blood dopamine levels

研究概览

简要总结

Our primary aim is to compare the change in blood dopamine levels with a single dose of these two drugs in patients with unilateral findings or axial involvement. Our study aims to obtain guiding data to make dose adjustments when giving treatment to patients. Although a linear dose curve of levodopa is observed in healthy volunteers, our study will provide the first data in this field, as there is no comparative study between the two drugs on patients with unilateral and axial involvement.

详细描述

After more than 40 years of routine clinical use, levodopa has remained the gold standard of symptomatic efficacy in the treatment of Parkinson's disease (PD). Levodopa benserazide and levodopa carbidopa entacapone are antiparkinsonian agents used to treat the motor symptoms of Parkinson's disease.

Parkinson's disease is a neurodegenerative disease characterized by the loss of dopamine-producing neurons in the brain. Dopamine is a neurotransmitter that is central to controlling movement in the brain. Dopamine deficiency leads to motor symptoms typical of Parkinson's disease. These symptoms are tremor, rigidity, bradykinesia and postural instability. Levodopa is an amino acid that is the precursor of dopamine. When levodopa reaches the brain, it participates in dopamine synthesis and increases dopaminergic activity. Levodopa is the most effective agent in treating the motor symptoms of Parkinson's disease. However, chronic use of levodopa can lead to motor complications. These may include end-of-dose worsening, motor fluctuations and dyskinesias. These complications are due to levodopa's short half-life and pulsatile stimulation of striatal dopamine receptors. A dopa decarboxylase inhibitor (DDCI) is added to levodopa to reduce the peripheral metabolism of levodopa and prevent nausea. These inhibitors may be carbidopa or benserazide. The main peripheral pathway of metabolism of levodopa given with DDCI is the catechol-O-methyl transferase (COMT) enzyme. Entacapone, a drug that inhibits the COMT enzyme, can also be added to the levodopa/DDCI combination. Entacapone prolongs the peripheral half-life of levodopa and increases its central bioavailability.

Levodopa is always combined with a dopa-decarboxylase inhibitor (DDCI), and available preparations use either carbidopa or benserazide to block the main levodopa-metabolizing enzyme. Previous randomized, controlled studies in PD patients reported that clinical effects and levodopa pharmacokinetics (PK) were comparable between carbidopa and benserazide.

Levodopa benserazide and levodopa carbidopa entacapone combinations are effective and safe antiparkinson agents in treating motor symptoms in Parkinson's disease. These drugs increase ON-time and decrease OFF-time in Parkinson's disease patients and provide symptomatic relief. In some selected patients with advanced stages and dyskinesia, levodopa carbidopa can be used in device-assisted treatments in the form of intestinal gel.

Apart from levodopa preparations, it is widely used in preparations containing rasagiline in our country as a monoamine oxidase (MAO) inhibitor in Parkinson's patients. Apart from this, another group of drugs aimed at reducing symptoms in young patients are drugs called dopamine agonists, which are given to the body to synthesize dopamine. Among these treatments, pramipexole, ropirinol and apomorphine, which can be given with device support or given by subcutaneous injection, are used in our country. Deep brain stimulation, also known as brain stimulation, is another treatment method applied to invasive selected patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic parkinson disease with early stage unilateral manifestations or axial involvement (hoehn yahr stage 1 and 1.5)
  • 40-75 years old years
  • Not taking levodopa preparations in the last 12 hours
  • Not having eaten for at least 2 hours
  • Agreeing to participate in the study

排除标准

  • Patients under 40 years of age and over 75 years of age
  • Taking levodopa preparations in the last 12 hours
  • Having bilateral, axial involvement
  • Having postural abnormalities
  • Having balance disorders (Hoehn yahr stage 3 and above)
  • Having eaten at least 1 hour ago
  • Not agreeing to participate in the study
  • Body mass index of 35 kg/m2 and above
  • Use of apomorphine, levodopa/carbidopa intestinal gel
  • Applying deep brain stimulation treatment
  • Using a daily dose of levodopa over 800 mg
  • Having dyskinesia
  • Drug-induced parkinsonism
  • Pregnant, postpartum and breastfeeding mothers

结局指标

主要结局

blood dopamine levels

时间窗: 0-90-180 minute

After the study patients are given levodopa benserazide (100+25 mg) or levodopa carbidopa entacapone (100+25+200 mg), blood samples will be taken from the patients 3 times at 0 minutes and then at 90 and 180 minutes.

次要结局

未报告次要终点

研究者

发起方
Ankara Ataturk Sanatorium Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Osman Korucu

assocciation proffesor

Ankara Ataturk Sanatorium Training and Research Hospital

研究点 (2)

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