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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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21 December 2021 |
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Main ID: |
EUCTR2007-000801-30-PL |
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Date of registration:
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17/07/2007 |
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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 Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations
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Scientific title:
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A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations |
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Date of first enrolment:
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29/08/2007 |
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Target sample size:
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726 |
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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:2007-000801-30 |
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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: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
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): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Czech Republic
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Estonia
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France
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Hungary
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Italy
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Latvia
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Lithuania
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Poland
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Spain
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Male or female subjects with idiopathic PD who have fulfilled the entry criteria to studies E2007-G000-309 or E2007-E044-213. Subjects must have completed the core efficacy study up to and including the final efficacy and follow up visits as applicable. Subjects with ongoing SAEs that are possibly or probably related to study medication cannot be enrolled in this Open Label Extension. Subjects with ongoing AEs categorized as severe and thought to be related to E2007 should not be entered. Subjects with mild or moderate AEs thought to be related to E2007 can be entered into the study if the investigator considers it safe.
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. Show evidence of clinically significant disease (ie, severe cardiovascular or pulmonary disease, bronchial asthma, endocrine disease, history of peptic ulcer disease, history of myocardial infarction with residual atrial nodal or ventricular arrhythmias) that, in the opinion of the investigator, could affect either the patient’s safety or the conduct of the study
2. Pregnant or lactating women
3. Women of childbearing potential (WOCBP) unless infertile (including surgically sterile) or practicing effective contraception (eg, intrauterine device [IUD] or barrier method plus hormonal method). These subjects must have a negative urine pregnancy test at Visit 1 or 2 as indicated by entry into the study. These subjects must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrhoeic for at least 1 year to be considered of non-child bearing potential as determined by the investigator.
4. Subjects with a past (within the past 5 years) or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM IV) criteria
5. Antipsychotics are permitted as necessary. Subjects may be taking anti-depressant medication, however the dose must be stable for 4 weeks prior to their first study visit (the visit at which the inclusion and exclusion criteria are done with the patient).
6. Subjects with a past (within one year) or present history of major depression, suicidal ideation, or suicide attempts
7. Subjects with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastrointestinal, haematological, endocrine, or metabolic systems that might complicate assessment of the tolerability of the study medication
8. Subjects with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper limit of the normal range)
9. Subjects with current or prior treatment (within 4 weeks prior to the Screening Visit) with medication known to induce the enzyme CYP3A4 (refer to list of Prohibited medications, Section 10.7)
10. Clinically significant ECG abnormality, and/or prolonged QTc (defined as QTc = 450 msec)
11. Current or prior treatment (within 4 weeks prior to entry visit) with tolcapone, methyldopa, budipine, or reserpine
12. Subjects with previous stereotactic surgery (eg, pallidotomy) for PD or with planned stereotactic surgery during the study period
13. Subjects receiving or with planned (next 12 months) deep brain stimulation
14. Subjects with conditions affecting the peripheral or central sensory system unless related to PD (such as mild sensory or pain syndromes limited to OFF periods) that could interfere with the evaluation of any such symptoms caused by the study medication
15. Subjects have received an investigational product (other than E2007 or entacapone 200 mg) within 4 weeks prior to Screening
16. Any condition that could, in the opinion of the investigator, place the subject at increased risk or is likely to prevent completion of the study
17. Subjects with any condition that would make the subject, in the opinion of the investigator, unsuitable for the study
18. Patients on pergolide
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: 9.1
Level: LLT
Classification code 10013113
Term: Disease Parkinson's
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Intervention(s)
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Product Name: E2007
Product Code: MARS
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: E2007
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
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Primary Outcome(s)
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Secondary Objective: To evaluate the long-term, 1-year maintenance of E2007 efficacy in subjects with PD who experience end-of-dose “wearing-off” motor fluctuations including the duration of OFF time during the waking day, and ON period dyskinesias
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Primary end point(s): To evaluate the long-term safety, tolerability, and efficacy of E2007 as an adjunctive therapy in levodopa treated PD subjects with motor fluctuations. All subjects who have completed E2007-E044-213 or E2007-G000-309 will be candidates for entering this extension trial, provided that they meet the inclusion/exclusion criteria and have completed the core study, up to and including the final efficacy visit.
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Main Objective: To evaluate the long-term safety and tolerability of E2007 in subjects with Parkinson’s disease (PD) who experience end-of-dose “wearing-off” motor fluctuations
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Secondary ID(s)
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2007-000801-30-CZ
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E2007-G000-318
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 24/07/2007
Contact:
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