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Efficacy of levodopa/carbidopa/entacapone in the replacement of Levodopa /dopa decarboxylase inhibitor in the treatment of 'Wearing-off' in Patients with Parkinson's disease in China: a multicenter, randomized controlled, open study

Efficacy of levodopa/carbidopa/entacapone in the replacement of Levodopa /dopa decarboxylase inhibitor in the treatment of 'Wearing-off' in Patients with Parkinson's disease in China: a multicenter, randomized controlled, open study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039050
Enrollment
Unknown
Registered
2020-10-14
Start date
2020-10-30
Completion date
Unknown
Last updated
2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Interventions

Group 1:adding pramipexole
Group 2:adding LCE

Sponsors

The Affiliated Brain Hospital of Nanjing Medical University (Nanjing Brain Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Primary PD patients (according to MDS2015 Parkinson's Disease diagnostic criteria); (2) Aged 30-80 years, no gender limitationg; (3) WOQ-19 more than on positive; (4) The dose of levodopa >= 300mg/ day and need to adjust the current anti-Parkinson's drugs; (5) H-Y stage 1.5-4; (6) Daily "off" period >= 1.5 hours; (7) Signing the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with atypical Parkinson's syndrome or Parkinson's superimposed syndrome; (2) Performed any surgical treatment in the half year before the trial; (3) Patients with severe hypertension (blood pressure >= 180mmHg) and unsatisfactory control; (4) Patients with severe cerebral arteriosclerosis, cerebrovascular disease and limb dysfunction caused by cerebrovascular disease; (5) Alcoholism, drug addiction or severe mental impairment (including severe dementia), failure to take drugs on time and cooperation with the examiner (Simple Intelligence Status Check Scale;Illiteracy was 2.5 times of normal value; Renal dysfunction: the normal value of creatinine > is 1.5 times; (12) ECG abnormalities: clinically significant QT interval prolongation (450ms in male and 470ms in female), ventricular tachycardia, atrial fibrillation, and heart block.

Design outcomes

Primary

MeasureTime frame
'off' time;

Secondary

MeasureTime frame
'on' time;MDS-UPDRS;

Countries

China

Contacts

Public ContactWeiguo Liu

The Affiliated Brain Hospital of Nanjing Medical University (Nanjing Brain Hospital)

wgliunbh@sina.com+86 13914725569

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026