Comparison of Dopamin Level in Idiopathic Parkinson's Patients

NCT06115538 | Unknown Phase 4

• 1 other identifier: AnkaraAtaturkSTRH-KORUCU-001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Treatment Adherence

Keywords

Levodopa; carbidopa; parkinson; benserazid; entacapone

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

levodopa benserazide group

ACTIVE COMPARATOR

levodopa benserazide (100+25 mg)

Other: Levodopa

levodopa carbidopa entakapon grubu

ACTIVE COMPARATOR

levodopa carbidopa entacapone (100+25+200 mg)

Other: Levodopa

Interventions

Levodopa OTHER

Levodopa benserazide (100+25 mg) will be given to one group of study patients, and levodopa carbidopa entacapone (100+25+200 mg) will be given to the other group of study patients. Just before the drugs are given (0th minute), at 90 and 180 minutes after the drugs are given, a total of 3 doses will be given.

Also known as: dopalevo madopar

levodopa benserazide group; levodopa carbidopa entakapon grubu

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic parkinson disease with early stage unilateral manifestations or axial involvement (hoehn yahr stage 1 and 1.5)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Ataturk Sanatorium Training and Research Hospital: lead

Study Sites (1)

Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, 063000, Turkey (Türkiye)

Location

Related Publications (4)

• 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 May-Jun;35(3):111-7. doi: 10.1097/WNF.0b013e31825645d1.

  PMID: 22549097 RESULT

• 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 (Madopar). Br J Clin Pharmacol. 2019 Nov;85(11):2605-2613. doi: 10.1111/bcp.14086. Epub 2019 Sep 12.

  PMID: 31378952 RESULT

• 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 Trial. JAMA Neurol. 2017 Feb 1;74(2):216-224. doi: 10.1001/jamaneurol.2016.4467.

  PMID: 27942720 RESULT

• 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/s00702-015-1449-6. Epub 2015 Sep 7.

  PMID: 26347184 RESULT

MeSH Terms

Conditions

Parkinson Disease; Treatment Adherence and Compliance

Interventions

Levodopa

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• osman korucu, assoc. prof

  Ankara Ataturk Sanatorium Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assocciation proffesor

Model Details: randomized controlled trial Our study is a randomized controlled study. After two different Levodopa preparations (drugs or biologic products) are given to the patients, blood will be taken from the patients at regular intervals (intervention) and the changes in blood dopamine levels between the 2 groups will be examined.

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: October 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: April 30, 2025
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

TU (1)