Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics (DYSK-PD-2007)

Uppsala University

Status and phase: Completed; Phase 4

Conditions: Parkinson Disease; Dyskinesias

Treatments: Drug: levodopa/carbidopa

Study type: Interventional

Funder types: Other

Identifiers

NCT00888186

DYSK-PD-2007

Details and patient eligibility

About

The purpose of this study is to study different kinds of dyskinesias in advanced Parkinson's disease appearing at different levels of levodopa infusion dose. The hypothesis is that different dyskinesias (dystonia, chorea) correlate to different levels of levodopa concentrations, as detected in plasma.

Full description

By using duodenal infusion of levodopa/carbidopa, the plasma concentration of levodopa can be kept fairly constant. Different doses, 10-20% higher or lower than the individually optimized dose will be used. Motor performance is captured by video recordings to be compared to/correlated with plasma levodopa concentrations.

Enrollment: 5 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of idiopathic Parkinson's disease
• Ongoing treatment with Duodopa
• Occurrence of dyskinesias, difficult to manage
• Age 30-90 years
• Hoehn & Yahr stage 3-5 at worst

Exclusion criteria

• Treatment with dopamine agonist or glutamate antagonist
• Dementia
• Psychosis
• Treatment with typical neuroleptics

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

5 participants in 5 patient groups

1. Duodopa optimal dose

Active Comparator group

Treatment:

Drug: levodopa/carbidopa

2. Duodopa 20% too high dose

Experimental group

Treatment:

Drug: levodopa/carbidopa

3. Duodopa 10% too low dose

Experimental group

Treatment:

Drug: levodopa/carbidopa

4. Duodopa 20% too low dose

Experimental group

Treatment:

Drug: levodopa/carbidopa

5. Duodopa 10% too high dose

Experimental group

Treatment:

Drug: levodopa/carbidopa