Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics

Parkinson Disease Clinical Trial

— DYSK-PD-2007  

Official title:

Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888186
• Other study ID #: DYSK-PD-2007
• Status: Completed
• Phase: Phase 4
• First received: April 24, 2009
• Last updated: April 24, 2009
• Start date: February 2008
• Est. completion date: May 2008

Study information

• Verified date: April 2009
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease

Intervention

Drug:
• levodopa/carbidopa
intestinal gel, for continuous daytime infusion

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University	Swedish Parkinson's Disease Foundation, Swedish Society for Medical Research

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Nyholm D, Nilsson Remahl AI, Dizdar N, Constantinescu R, Holmberg B, Jansson R, Aquilonius SM, Askmark H. Duodenal levodopa infusion monotherapy vs oral polypharmacy in advanced Parkinson disease. Neurology. 2005 Jan 25;64(2):216-23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism		3 days	No
Secondary	Correlation between choreatic dyskinesia, dystonia, and parkinsonism.		3 days	No