E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations. |
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E.1.1.1 | Medical condition in easily understood language |
Advanced Parkinson's Disease |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013113 |
E.1.2 | Term | Disease Parkinson's |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study will be to evaluate the ong-term safety of LCIG over a 12-month period. |
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E.2.2 | Secondary objectives of the trial |
A secondary objective will be to assess the long-term maintenance of efficacy and health outcome measures as measured by change from Baseline to Endpoint using the following assessments: ● "Off" time as measured by the Parkinson's Disease Diary ● "On" time without troublesome dyskinesia as measured by the Parkinson's Disease Diary ● UPDRS Parts I, II, III and IV ● PDQ-39 ● CGI-I ● EQ-5D ● Caregiver burden (ZBI) The efficacy analysis will serve the purpose of hypothesis generation.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, subjects must meet the following criteria: 1. Completion of 12 weeks of double-blind treatment in either Study S187.3.001 or S187.3.002 and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG. No minimum "Off" time is required based on the Parkinson's Disease Diary. 2. 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 subject's current therapeutic regimen). 3. The subject must be willing to continue on treatment, and must continue to meet the inclusion criteria for the preceding study (Study S187.3.001 or S187.3.002), with the exception that ESC review and approval of eligibility is not required for Study S187.3.003. |
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E.4 | Principal exclusion criteria |
Subjects meeting any of the exclusion criteria listed below at Baseline must be excluded from participation in the study. 1. Subject may not be enrolled in another clinical trial. 2. Psychiatric, neurological or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study. 3. Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant. 4. Uncooperative attitude or reasonable likelihood for non-compliance with the protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety: The safety and tolerability of LCIG will be assessed by the following: ● Physical examination, including weight ● Neurological examination ● Vital signs ● Resting ECGs ● Clinical laboratory assessments including biochemistry, hematology, urinalysis, and special labs to monitor for vitamin deficiencies ● Concomitant medication usage ● Adverse event monitoring, including for the development of sleep attacks, melanoma, or excessive impulsive behavior ● Monitoring complications of the infusion device ● Abnormal Involuntary Movement Scale (AIMS) ● Tolerability assessed by number of subjects who complete the study |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Efficacy: Efficacy will be assessed using the Parkinson's Disease Diary© (Symptom Diary) for "Off" time and "On" time without troublesome dyskinesia, and the UPDRS, CGI-I, and CGI-S.
Quality of life and caregiver burden will be assessed using the EQ-5D, PDQ-39 and ZBI.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 |
Germany |
New Zealand |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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End of the study is defined as Last Subject Last Visit + 30 days |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |