E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Levodopa treated Parkinson's disease patients with motor fluctuations. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061536 |
E.1.2 | Term | Parkinson's disease |
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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 evaluate the long-term safety and tolerability of E2007 as an adjunctive therapy in levodopa treated Parkinson’s disease (PD) patients with motor fluctuations. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the long-term efficacy of E2007 on the motor fluctuations of Parkinson’s disease including the duration of OFF time during the waking day, and ON period dyskinesias. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female patients with idiopathic PD who have fulfilled the entry criteria to either E2007-E044-301 or E2007-A001-302 and have completed that study up to and including the final efficacy visit. 2. Patients will not be eligible if they withdrew from the core study prior to the final efficacy visit for any reason including lack of efficacy. 3. Patients with SAEs which are ongoing or possibly or probably related to the study drug, will not be eligible for this study. 4. Patients with ongoing adverse events categorized as severe and thought to be related to E2007 should not be entered. 5. Patients with mild or moderate adverse events thought to be related to E2007 can be entered to the study if the investigator considers it safe. |
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E.4 | Principal exclusion criteria |
1. Pregnant or lactating women. 2. Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g. abstinence, IUD or barrier method plus hormonal method). These patients must have a negative serum or urine β-HCG test at their first study visit. These patients 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. 3. Patients with a past (within the past 5 years) or present history of drug or alcohol abuse as per DSM IV criteria. 4. Patients with a past (within one year) or present history of suicidal ideation or suicide attempts. 5. Patients with a past (within one year) or present history of psychotic symptoms requiring antipsychotic treatment. Patients may be taking anti-depressant medication, however the dose must be stable for 4 weeks prior to the baseline visit. Use of anti-psychotic medication including clozapine and quetiapine is prohibited even if the indication is for movement disorders. 6. Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, haematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication. 7. Patients with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper normal limit). 8. Medication known to induce the enzyme cytochrome P450 3A4 is prohibited throughout the study. 9. Current or prior treatment (within 4 weeks prior to entry visit) with tolcapone, methyldopa, budipine, reserpine, seroquel. 10. Patients with conditions affecting the peripheral or central sensory system unless related to Parkinson’s disease (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 drug. 11. Patients receiving or with planned (next 12 months) deep brain stimulation. 12. Patients with any condition that would make the patient, in the opinion of the Investigator, unsuitable for the study. 13. Patients with clinically significant ECG abnormalities, including prolonged QTc (defined as QTc ≥ 450 msec) (added per Amendment 01). 14. Patients with previous stereotactic surgery (eg, pallidotomy) for Parkinson’s disease or with planned stereotactic surgery during the study period (added per Amendment 01). 15. Patients on pergolide as of April 5, 2007 (added per Amendment 02)
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E.5 End points |
E.5.1 | Primary end point(s) |
-Patient diaries: Change from baseline to the efficacy visit at week 56 in the mean total daily OFF time. -Patient Diaries: Change from baseline to the efficacy visit at week 56 on the average OFF time. -Patient Diaries: Change from baseline to final efficacy visit in the mean total daily ON time without dyskinesias or with non troublesome dyskinesias. -Patient Diaries: Change from baseline to final efficacy visit in the mean total daily ON time with dyskinesias. - UPDRS Part II (ADL): OFF state - UPDRS Part III (Motor): ON state
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 104 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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The end of the study will be the date of the last visit of the last patient(s) participating in 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 | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |