DAPHNE (Duodopa in Advanced Parkinson's: Health Outcomes & Net Economic Impact)

Advanced Idiopathic Parkinson's Disease Clinical Trial

Official title:

A Long-term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/Dyskinesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141518
• Other study ID #: S187.4.001
• Secondary ID: 2005-002654-21
• Status: Completed
• Phase: Phase 4
• First received: August 30, 2005
• Last updated: March 30, 2012
• Start date: January 2006
• Est. completion date: April 2011

Study information

• Verified date: March 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

Health economics long-term study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Advanced idiopathic Parkinson's disease

Exclusion Criteria

• Other diseases which might influence compliance or participation in the study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• Levodopa-carbidopa in an intestinal gel formulation
should be kept within a range of 0.5-10 ml/hour (1--200 mg levodopa/hour) and is usually 2-6 ml/hour (40-120 mg levodopa/hour)

Device:
• CADD-Legacy® 1400
Ambulatory infusion pump

Locations

Country	Name	City	State
Norway	Site Reference ID/Investigator# 60023	Molde
Sweden	Site Reference ID/Investigator# 60045	Gothenburg
Sweden	Site Reference ID/Investigator# 60042	Huddinge
Sweden	Site Reference ID/Investigator# 60047	Linkoping
Sweden	Site Reference ID/Investigator# 60046	Lund
Sweden	Site Reference ID/Investigator# 60050	Stockholm
Sweden	Site Reference ID/Investigator# 60044	Sundsvall
Sweden	Site Reference ID/Investigator# 60049	Umea
Sweden	Site Reference ID/Investigator# 60043	Uppsala
Sweden	Site Reference ID/Investigator# 60048	Visby

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UPDRS and EQ-5D		3 years	No
Secondary	Hoehn and Yahr, Schwab and England, MMSE, MADRS, PDQ-39, e-diary		3 years	No