Parkinson Disease Clinical Trial
Official title:
Comparison of Blood Dopamine Levels in Idiopathic Parkinson's Patients Receiving Levodopa Carbidopa Entacapone or Levodopa Benserazide
Verified date | November 2023 |
Source | Ankara Ataturk Sanatorium Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 96 |
Est. completion date | April 30, 2025 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara Atatürk Sanatorium Training and Research Hospital | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara Ataturk Sanatorium Training and Research Hospital |
Turkey,
Kuoppamaki M, Leinonen M, Poewe W. Efficacy and safety of entacapone in levodopa/carbidopa versus levodopa/benserazide treated Parkinson's disease patients with wearing-off. J Neural Transm (Vienna). 2015 Dec;122(12):1709-14. doi: 10.1007/s00702-015-1449- — View Citation
Nyholm D, Lewander T, Gomes-Trolin C, Backstrom T, Panagiotidis G, Ehrnebo M, Nystrom C, Aquilonius SM. Pharmacokinetics of levodopa/carbidopa microtablets versus levodopa/benserazide and levodopa/carbidopa in healthy volunteers. Clin Neuropharmacol. 2012 — View Citation
Schapira AH, Fox SH, Hauser RA, Jankovic J, Jost WH, Kenney C, Kulisevsky J, Pahwa R, Poewe W, Anand R. Assessment of Safety and Efficacy of Safinamide as a Levodopa Adjunct in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical — View Citation
Torti M, Alessandroni J, Bravi D, Casali M, Grassini P, Fossati C, Ialongo C, Onofrj M, Radicati FG, Vacca L, Bonassi S, Stocchi F. Clinical and pharmacokinetics equivalence of multiple doses of levodopa benserazide generic formulation vs the originator ( — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | blood dopamine levels | 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. | 0-90-180 minute |
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