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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
  Purpose

Health economics long-term study


Condition Intervention Phase
Advanced Idiopathic Parkinson's Disease
Drug: Levodopa-carbidopa in an intestinal gel formulation
Device: CADD-Legacy® 1400
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • UPDRS and EQ-5D [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hoehn and Yahr, Schwab and England, MMSE, MADRS, PDQ-39, e-diary [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: January 2006
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

- Advanced idiopathic Parkinson's disease

Exclusion Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141518

Locations
Norway
Site Reference ID/Investigator# 60023
Molde, Norway, 6407
Sweden
Site Reference ID/Investigator# 60045
Gothenburg, Sweden, 413 45
Site Reference ID/Investigator# 60042
Huddinge, Sweden, SE-141 86
Site Reference ID/Investigator# 60047
Linkoping, Sweden, 581 85
Site Reference ID/Investigator# 60046
Lund, Sweden, 22185
Site Reference ID/Investigator# 60050
Stockholm, Sweden, 17176
Site Reference ID/Investigator# 60044
Sundsvall, Sweden, 851 86
Site Reference ID/Investigator# 60049
Umea, Sweden, 901 85
Site Reference ID/Investigator# 60043
Uppsala, Sweden, 75185
Site Reference ID/Investigator# 60048
Visby, Sweden, SE-62155
Sponsors and Collaborators
Abbott
Investigators
Study Director: Sabine Neumann, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00141518     History of Changes
Other Study ID Numbers: S187.4.001, 2005-002654-21
Study First Received: August 30, 2005
Last Updated: March 30, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Abbott:
Health economics
Quality of life

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Levodopa
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014