Comparison of Dopamin Level in Idiopathic Parkinson's Patients

Launched by ANKARA ATATURK SANATORIUM TRAINING AND RESEARCH HOSPITAL · Oct 30, 2023

Keywords

ClinConnect Summary

This study is testing how two common Parkinson’s medicines, given with different accompanying drugs, affect the amount of dopamine in the blood after a single dose. Adults with early-stage Parkinson’s disease who have mainly one-sided symptoms (or only mild axial involvement) are randomly assigned to receive either levodopa benserazide (Madopar) or levodopa carbidopa entacapone (Dopalevo). Researchers will measure blood dopamine levels right before dosing, and then 90 and 180 minutes after taking the medicine, to see which combination might lead to more predictable dopamine levels and better guide future dosing.

If you qualify, you’d be 40–75 years old, not have had levodopa in the last 12 hours, and not have bilateral symptoms or other major exclusions. The study involves one visit where you’ll receive three doses over a short period and have three blood samples taken, with side effects checked for about three hours afterward. The trial is taking place at Ankara Atatürk Sanatorium Training and Research Hospital in Turkey and aims to enroll about 96 people. Results aren’t available yet, but the study is designed to help doctors choose between these two drug combinations in the future.

Gender

ALL

Eligibility criteria

• 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