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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00141518
First received: August 30, 2005
Last updated: March 30, 2012
Last verified: March 2012

August 30, 2005
March 30, 2012
January 2006
March 2011   (final data collection date for primary outcome measure)
UPDRS and EQ-5D [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00141518 on ClinicalTrials.gov Archive Site
Hoehn and Yahr, Schwab and England, MMSE, MADRS, PDQ-39, e-diary [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
DAPHNE (Duodopa in Advanced Parkinson's: Health Outcomes & Net Economic Impact)
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

Health economics long-term study

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Idiopathic Parkinson's Disease
  • 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
Experimental: 1
Interventions:
  • Drug: Levodopa-carbidopa in an intestinal gel formulation
  • Device: CADD-Legacy® 1400
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
April 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria

- Advanced idiopathic Parkinson's disease

Exclusion Criteria

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway,   Sweden
 
NCT00141518
S187.4.001, 2005-002654-21
Not Provided
Abbott
Abbott
Not Provided
Study Director: Sabine Neumann, MD Abbott
Abbott
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP