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Basic and Clinical Studies of Levodopa/Carbidopa/Entacapone in the Treatment of Early Parkinson's Disease

Recruiting
30 - 80 years of age
Both
Phase 4

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Overview

This is a, open-label, single-arm 8-week investigation of levodopa/carbidopa/entacapone in the treatment of early Parkinson's disease.

Description

This study will enroll subjects who have a diagnosis of PD with Hoehn-Yahr stage 1.5-3.0 and assess the impact of low dosage of levodopa/carbidopa/entacapone treatment on the motor function and quality of life among PD patients.

Eligibility

Inclusion Criteria:

  • Male or female and greater from 30 to 80.
  • Diagnosis of idiopathic PD according to the MDS PD Diagnostic Criteria (2015).
  • Hoehn-Yahr stage of 1.5-3.0 ("open" stage).
  • Not on anti-PD medication or stable on anti-PD medication for at least 30 days.

Exclusion Criteria:

  • Diagnosis of atypical Parkinsonian syndrome, vascular Parkinsonism or drug-induced Parkinsonism.
  • History of surgery within 6 months.
  • Alcoholism, drug abuse, or severe cognitive impairment (including severe Alzheimer's disease)
  • Psychiatric illness, epilepsy, pregnancy and breastfeeding, and clinically significant concomitant illnesses
  • Participation in another clinical trial within 2 months.
  • With dyskinesia.
  • Any other condition that, in the opinion of the investigator, makes them ineligible for enrolment.

Study details

Parkinson Disease

NCT06236230

Second Affiliated Hospital of Soochow University

18 February 2024

Step 1 Get in touch with the nearest study center
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  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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