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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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25 November 2019 |
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Main ID: |
EUCTR2006-001755-36-GB |
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Date of registration:
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29/09/2006 |
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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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Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE
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Scientific title:
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Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE |
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Date of first enrolment:
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20/11/2006 |
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Target sample size:
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100 |
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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:2006-001755-36 |
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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:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Germany
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Written informed consent obtained.
2. Male or female subjects with idiopathic PD and early WO symptoms treated with
standard levodopa/DDCI treatment.
3. Hoehn and Yahr stage 1-3 performed during the ‘ON’-state.
4. Age = 35 years.
5. At least 1 symptom identified by WOQ-9.
6. Dosing frequency of 3-4 daily doses of standard-release levodopa/DDCI maximum total daily dose of 600 mg of standard-release levodopa).
7. Unchanged levodopa/DDCI and other antiparkinsonian medication (amantadine,
selegiline up to 10 mg/day, rasagiline up to 1 mg/day, anticholinergics and/or dopamine agonists), if any, for at least 6 weeks preceding baseline (V1).
8. Willingness to change his/her current regimen of levodopa/DDCI due to the identified WO symptom(s) to an equivalent dose of Stalevo®.
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. Atypical or symptomatic parkinsonism.
2. Unpredictable OFF-periods.
3. Any peak-dose dyskinesia. ‘OFF’-state dystonia is allowed.
4. Use of more than 1 evening dose of controlled-release (CR) levodopa/DDCI.
5. Use of any rescue medications to treat symptoms of ‘OFF’-state. 1 dose of soluble
levodopa/DDCI as the first morning dose is allowed.
6. Concomitant treatment with non-selective monoamine oxidase (MAO) inhibitor or
simultaneous use of higher than recommended doses of MAO-A and MAO-B inhibitors
(selegiline 10 mg or rasagiline 1 mg allowed) or use of apomorphine.
7. Concomitant treatment with drugs having antidopaminergic action, including alphamethyldopa, reserpine and antipsychotic drugs (also D2 receptor blocking antiemetics, except domperidone). As an exception to prohibited use of antipsychotic drugs, 1 daily dose of amisulipride, clozapine, olanzapine, quetiapine, risperidone, ziprasidone or zotepine at night is allowed.
8. Clinically significant (e.g. cardiovascular, hepatic, renal, pulmonary, gastrointestinal
neurological or psychiatric) disorder, which may influence the outcome of the study.
9. History of narrow-angle glaucoma, pheochromocytoma, neuroleptic malignant syndrome (NMS) and/or rhabdomyolysis.
10. Current malignancy.
11. Severe hepatic impairment.
12. Any abnormal laboratory value with clinical relevance.
13. Any abnormal electrocardiogram (ECG) finding with clinical relevance.
14. Female subjects of childbearing potential (menstruating, or less than 2 years postmenopausal) who are not using proper contraception (hormonal contraception,
intrauterine device or surgical sterilization) during the study.
15. Pregnancy and lactation.
16. Treatment with a Catechol-O-Methyltransferase (COMT) inhibitor within the last 6
weeks.
17. Known previous adverse drug reaction (ADR) or hypersensitivity to a COMT inhibitor.
18. Participation in any other clinical studies within 30 days prior to study entry or earlier treatment with Stalevo®.
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
MedDRA version: 8.1
Level: LLT
Classification code 10061536
Term: Parkinson's disease
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Intervention(s)
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Trade Name: Stalevo
Product Name: Stalevo
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Levodopa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: Carbidopa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
INN or Proposed INN: Entacapone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: Stalevo
Product Name: Stalevo
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Levodopa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: Carbidopa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
INN or Proposed INN: Entacapone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: Stalevo
Product Name: Stalevo
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Levodopa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
INN or Proposed INN: Carbidopa
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 37.5-
INN or Proposed INN: Entacapone
Concentration unit: mg milligram(s)
Concentration type:
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Primary Outcome(s)
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Secondary Objective: - to study the change in subject’s clinical condition by CGI-C as judged by the investigator
- to study the change in subject’s clinical condition by change of Unified Parkinson’s Disease Rating Scale (UPDRS) II (activity of daily living) and UPDRS III (motor disability)
- to investigate the QoL at baseline and the change from baseline at the end of the study by a QoL visual analogue scale (VAS)
- to study the effect of Stalevo® on motor and non-motor WO symptoms.
An additional objective is to study the change in the daily levodopa dose and the number of daily doses.
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Primary end point(s): Switch-related efficacy from baseline assessed by the patient’s CGI-C at visit V5 (6 weeks)/premature discontinuation.
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Main Objective: to provide efficacy data of the direct switch from levodopa/carbidopa or levodopa/benserazide to levodopa/carbidopa/entacapone (Stalevo®) by clinical global impression of change (CGI-C) as judged by the subject him/herself.
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Secondary ID(s)
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2006-001755-36-SE
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2939117
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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