Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease

University of Helsinki

Status and phase: Completed; Phase 4

Conditions: Parkinson's Disease

Treatments: Drug: Levodopa infusion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00914134

PDAUT2009

Details and patient eligibility

About

The aim of the study is to assess the effect of continuous levodopa infusion on autonomic nervous system in patients with Parkinson's Disease (PD), blood pressure regulation and sweating. The investigators' hypothesis is that levodopa infusion may alleviate hyperhidrosis and orthostatic hypotension.

Full description

Parkinson's disease (PD) is one of the most common neurodegenerative disorders with increasing prevalence because of aging population. The main symptoms include rigidity, hypokinesia, tremor and impaired balance, but the disease also causes autonomic dysfunction. Motor fluctuations are common treatment related problems in PD, around 50-70% of patients treated with levodopa finally develop motor fluctuations. Continuous duodenal levodopa infusion has been effective in the treatment of motor dysfunction in advanced PD. However, little is known of its effects on autonomic nervous system.

Enrollment: 12 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of idiopathic Parkinson's disease: diagnosis made at least five years earlier
• Positive response to levodopa
• Motor fluctuations that cannot be adequately controlled with oral medication
• No signs or symptoms of cerebellar dysfunction or vascular parkinsonism

Exclusion criteria

• Severe cognitive symptoms
• Glaucoma
• Severe arrythmias
• Severe asthma or COPD
• Heart, liver or kidney failure
• No significant vascular lesions in brain MRI imaging.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Levodopa Infusion

Experimental group

Description:

Patients with advanced Parkinson's disease and motor fluctuations that cannot be adequately controlled with oral medication.

Treatment:

Drug: Levodopa infusion