Investigating a medication for early Parkinson's disease
Basic and Clinical Studies of Levodopa/Carbidopa/Entacapone in the Treatment of Early Parkinson's Disease
This study is testing if a low-dose combination of medications can help improve movement and quality of life for people with early Parkinson's disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Soochow University Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06236230 on ClinicalTrials.gov |
What this trial studies
This open-label, single-arm investigation will evaluate the effects of low doses of levodopa/carbidopa/entacapone on motor function and quality of life in patients diagnosed with early Parkinson's disease. The study will enroll participants aged 30 to 80 who are at Hoehn-Yahr stages 1.5 to 3.0 and are either not on anti-Parkinson's medication or have been stable on such medication for at least 30 days. Over an 8-week period, the impact of the treatment will be assessed to determine its efficacy in improving symptoms.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 30 to 80 with a diagnosis of idiopathic Parkinson's disease at Hoehn-Yahr stages 1.5 to 3.0.
Not a fit: Patients with atypical Parkinsonian syndromes, severe cognitive impairments, or those currently participating in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance motor function and quality of life for patients with early Parkinson's disease.
How similar studies have performed: Previous studies have shown positive outcomes with levodopa/carbidopa/entacapone in treating Parkinson's disease, indicating this approach has been tested with some success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai
- The Second Affiliated Hospital of Soochow University — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Chun-Feng Liu, MD,PhD — Second Affiliated Hospital of Soochow University
- Study coordinator: Chun-feng Liu, MD,PhD
- Email: liuchunfeng@suda.edu.cn
- Phone: +8613606210609
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.