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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2005-002654-21-SE |
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Date of registration:
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14/06/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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. - DAPHNE
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Scientific title:
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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. - DAPHNE |
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Date of first enrolment:
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08/08/2005 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002654-21 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Sweden
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Patients on treatment with Duodopa for at least 12 weeks prior to the study.
2. or Duodopa treatment naïve patients. In this case the following must be fulfilled: The investigator considers changing conventional Parkinson´s disease treatment. The criteria in the Summary of Product Characteristics for Duodopa must be fulfilled.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Patients suffering from other diseases that, in the opinion of the investigator, might interfere with the study objectives.
2. Patients that, in the opinion of the investigator, is unable to comply with study requirements.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.
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Intervention(s)
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Trade Name: Duodopa intestinal gel
Pharmaceutical Form: Gastroenteral suspension
INN or Proposed INN: Levodopa
CAS Number: 59-92-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20 -
INN or Proposed INN: Carbidopa
CAS Number: 28860-95-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
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Primary Outcome(s)
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Main Objective: The primary objective is to depict, over time, changes in costs and health related quality of life in patients treated with Duodopa.
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Secondary Objective: To assess quality of life and to study the safety of Duodopa.
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Primary end point(s): 1. Resource Use (RU): The use (intensity and frequency) of health care resources will be collected at baseline and throughout the study, in order to evaluate cost consequences of treatment with Duodopa.
2. Delayed disease progression and Utility: The Unified Parkinson’s Disease Rating Scale (UPDRS) will be used to measure (i) the progression of the disease over time and (ii) to elicit preference-based quality of life, or utility.
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Secondary ID(s)
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S187.4.001
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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