E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013113 |
E.1.2 | Term | Disease Parkinson's |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the effect of REQUIP® CR and IR on the discomfort induced by global daytime somnolence in PD patients suffering from REQUIP® IR induced daytime somnolence.
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E.2.2 | Secondary objectives of the trial |
To compare the effect of REQUIP® CR and IR on PD patients on other aspects of abnormal daytime somnolence and motor function; To assess safety and tolerability of REQUIP® CR versus REQUIP® IR.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients ≥ 30 and < 80 years of age • Male or non pregnant, non breastfeeding female. Women of childbearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study; • Clinical diagnosis of idiopathic Parkinson’s disease according to the UK Parkinson’s Disease Society Brain Bank Clinical Diagnosis Criteria (Gibb and Lees, 1988); • Patients capable of accurately filling rating scales; • Patients treated by REQUIP® IR at stable dose for at least one month; • Daytime somnolence present on REQUIP® IR with a minimal score of 10 on Epworth Sleepiness scale (Johns, 1991); • Modified Hoehn and Yahr stage < 4 in the “ON” state; • No significant cognitive impairment as defined by MMSE score > 24 • Stable dose of anti-Parkinsonian drug treatment including in addition to L-dopa: ReQuiP® IR, COMT inhibitors, selegiline, anticholinergics, amantadine for at least 1 month prior to inclusion; • All antiparkinsonian medications (other than REQUIP) expected to remain stable for the entire trial duration • Signed written informed consent by the patient to participate in the study and willingness and capacity to comply with all study procedures and scheduled visits, • Resident of France and fully insured
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E.4 | Principal exclusion criteria |
- Subjects with significant history of unstable medical illness over the last 30 days or with severe, clinically significant condition(s) other than Parkinson’s disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g. psychiatric (including previous hallucinations or psychotic symptoms within the previous 3 months), haematological, renal, hepatic, endocrinology, neurological [other than Parkinson’s disease], cardiovascular, or active malignancy); -Neurosurgical intervention for Parkinson’s disease (e.g. pallidotomy, thalamotomy, transplantation and deep brain stimulation) within less than one year before screening; - Current use (or within 3 months before enrolment) unauthorized concomitant treatments (classical or atypical neuroleptics; anti-emetic drugs with D2 receptor antagonistic properties such as metoclopramide, not including domperidone; budipine, riluzole, dextromethorphan, memantine); - Co-treatment with other dopamine agonist than ropinirole; - Antidepressants/anxiolytics/hypnotics treatment which has not been at a stable dose for at least 1 month prior to the study (dose has to remain stable during the study); - Modafinil/psychostimulants consumption within the 3 months preceding enroilment - participation in another trial of an investigational drug within the past 30 days (or within kess than 5 plasma elimination half-life); - Probable depressive symptoms (Hospital Anxiety Depression Scale > 11); - Significant cognitive impairment as defined by MMSE score 24, DSMIV criteria for dementia, or more generally limited mental capacity or psychiatric disease rendering the subject unable to provide written informed consent or comply with evaluation procedures; - History of recent (past two years) alcohol or drug abuse; - History of non-adherence with treatment or other experimental protocols; - Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude long-term dosing with ropinirole; - Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine,cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period (liver interaction); - Suspected inability to complete the study follow-up (foreign workers, transient visitors, tourists or any others for whom follow-up evaluation is not assured); - Female of childbearing potential (apart of patients using adequate contraceptive measures), pregnant or breast feeding; - Patients under legal guardianship ; |
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E.5 End points |
E.5.1 | Primary end point(s) |
7-points scale monitoring subjective discomfort induced by daytime somnolence in report to the previous week (the choice of this seven point subjective scale is driven by the fact that it is expected to be more sensitive to change in a single patient that other validated scale such as for example the ESS). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |