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Main
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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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20 July 2020 |
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Main ID: |
EUCTR2004-002641-12-GB |
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Date of registration:
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30/06/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease
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Scientific title:
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A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease |
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Date of first enrolment:
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16/05/2005 |
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Target sample size:
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220 |
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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:2004-002641-12 |
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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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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV):
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Countries of recruitment
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Austria
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Italy
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Spain
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United Kingdom
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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. Subject is informed and given ample time and opportunity to think about her/his
participation and has given her/his written informed consent.
2. Subject is willing and able to comply with all trial requirements.
3. Subject has completed Study SP824, SP825, or SP826.
4. Subject, in the opinion of the investigator, would benefit from long-term treatment
of rotigotine.
Are the trial subjects under 18?
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. Subject has an ongoing serious adverse event that is assessed as related to
study medication
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Parkinson's disease
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Intervention(s)
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Product Name: Rotigotine
Product Code: SPM 962
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: [99755-59-6]
Current Sponsor code: SPM 962
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4.5-
Product Name: Rotigotine
Product Code: SPM 962
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: [99755-59-6]
Current Sponsor code: SPM 962
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9.0-
Product Name: Rotigotine
Product Code: SPM 962
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: [99755-59-6]
Current Sponsor code: SPM 962
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 13.5-
Product Name: Rotigotine
Product Code: SPM 962
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Rotigotine
CAS Number: [99755-59-6]
Current Sponsor code: SPM 962
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18.0-
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Primary Outcome(s)
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Secondary Objective:
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Main Objective: to assess the safety and tolerability of long-term treatment of rotigotine, administered up to 2 years, until rotigotine is commercially available or until the sponsor closes the study, whichever comes first, in subjects with idiopathic Parkinson's disease
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Primary end point(s): • Frequency and severity of adverse events (AEs), as reported spontaneously by the
subject or observed by the investigator, recorded over the course of the trial
• Changes in vital signs, body weight, electrocardiograms (ECGs), and clinical
laboratory values over the course of the trial
• Changes in physical and neurological examination data over the course of the trial
• Changes in Epworth Sleepiness Scale (ESS) scores over the course of the trial
• Adhesiveness of the patch
• Clinical Global Impression (CGI) over the course of the trial
• Patient Global Impression (PGI) over the course of the trial
• Change from baseline in UPDRS Part I scores over the course of the trial
• Change from baseline in UPDRS Part II scores over the course of the trial
• Change from baseline in UPDRS Part III scores over the course of the trial
• Change from baseline in UPDRS Part IV scores over the course of the trial
• Change from pretreatment in Hoehn and Yahr stage over the course of the trial
• Change in quality of life, from baseline to end of the trial, as assessed using the
short-form Parkinson's Disease Questionnaire (PDQ-8)
• Change in quality of sleep, from baseline to end of the trial, as assessed using the
Parkinson's Disease Sleep Scale (PDSS)
• Rating of patch application site preference and satisfaction with trial treatment as
assessed by a patient preference questionnaire
Baseline for this open-label extension trial is defined as the subject’s baseline in SP824, SP825, or SP826.
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Secondary ID(s)
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SP833
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2004-002641-12-AT
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 30/10/2006
Contact:
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