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

Last updated: January 24, 2024
Sponsor: Second Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

levodopa/carbidopa/entacapone

Clinical Study ID

NCT06236230
JD-LK2023062-IR01
  • Ages 30-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: levodopa/carbidopa/entacapone
Phase: 4
Study Start date:
November 15, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • The Second Affiliated Hospital of Soochow University

    Shanghai, Shanghai 2I5004
    China

    Active - Recruiting

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