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 | 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 |
The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa) over 6-12-months in subjects with advanced Parkinsons Disease (PD) and severe motor-fluctuations who have not had optimal response to oral levodopa-carbidopa treatment. Additional supportive evidence for efficacy will be assessed in the treatment of severe motor-fluctuations, dyskinesia and mobility. |
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E.2.2 | Secondary objectives of the trial |
A secondary statistical objective is to assess the long-term maintenance of efficacy. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Diagnosis of idiopathic Parkinsons disease according to the United Kingdom Parkinsons Disease Society (UKPDS) Brain Bank Criteria with the diagnosis made at least 2 years prior to enrollment in the study. 2. The subjects Parkinsons disease must be the levodopa-responsive type as judged by the investigator; additionally, subjects will need to demonstrate severe motor fluctuations in spite of individually optimized oral treatment, and where other therapy options beside oral treatment are indicated. 3. Subjects have had optimal treatment with available PD medication as defined by local standards of care and, based upon the judgment of the investigator, are judged inadequately controlled on this optimized treatment. 4. Presence of a recognizable off and on state (motor fluctuations) as confirmed by diary at baseline (diary measurements performed for the three days preceding the baseline visit). 5. Subjects or subjects proxy/caretaker must be able to keep a subject diary of off time. 6. Minimum off time must be approximately 3 hours per day as estimated by the investigator. 7. The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subjects current therapeutic regimen). 8. Subjects must be able to speak, read, understand and possess the ability to respond to and follow simple instructions in their native language and/or in English. All required documents, including the informed consent, will be translated into the native language as appropriate. 9. Male or female subjects aged at least 30 years
See protocol for more details |
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E.4 | Principal exclusion criteria |
1. Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes (e.g., multiple system atrophy, progressive supranuclear palsy) or the other neurodegenerative diseases; 2. Subjects who have undergone surgery for the treatment of PD (e.g., pallidotomy, deep brain stimulation, fetal tissue transplantation); 3. Subjects with any neurological deficit that might interfere with the study assessments (e.g. hemiparesis); 4. Treatment with prohibited medications (see Section 7.8); 5. Known hypersensitivity to levodopa, carbidopa or radiopaque material; 6. Contraindications to levodopa, such as narrow angle glaucoma, hyperthyroidism, pheochromocytoma, Cushings syndrome and history of malignant melanoma; 7. Current diagnosis or history of drug or alcohol abuse (Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV-TR criteria) within 12 months prior to screening visit; 8. Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, such as bipolar disorder or major depressive disorder (DSM-IV-TR criteria); 9. Psychiatric, neurological or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct or interpretation of the study; troublesome hallucinations would also be included under this category;
See protocol for more details |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Change from baseline in mean daily off time (hours), based on a self-administered home diary assessment of motor state on three consecutive days at multiple intervals. - Change from baseline in the diary based assessment of on time with troublesome dyskinesia, and on time without troublesome dyskinesia - Clinical Global Impression-Improvement (CGI-I) scores - Unified Parkinsons Disease Rating Scale (UPDRS) total score and sub-scores of parts I-III. Practically defined off time (pre am dose) and best on time (1-2 hours post dose) and Part IV (subscore Dyskinesia items) - Total score Parkinsons Disease Questionnaire-39 (PDQ-39) |
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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 | Yes |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.6 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 | Information not present in EudraCT |
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 | 10 |
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 | 6 |