E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of Parkinson's Disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Classification code | 10029205 |
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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 determine the minimum effective dose (MED) and corresponding plasma concentrations of subcutaneous injections of FPFS-1169 in Parkinson’s disease patients. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the acute effects of subcutaneous injection of FPFS-1169 on the severity of parkinsonian signs in patients with mild to moderately advanced Parkinson’s disease.
To monitor the safety by means of frequent clinical evaluations and laboratory tests.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients who meet all of the following inclusion criteria at Day 0 will be eligible to participate in the study: 1. Patient is between the ages of 30 and 80; 2. Patient has been diagnosed with Parkinson's Disease based on the presence of a characteristic clinical history and neurological findings; 3. Patient is still responsive to L-Dopa treatment; 4. Patient is in a relatively mild to moderate Parkinson’s Disease stage at the Hoehn-Yahr disability scale up to grade III; 5. Patient should show typical Parkinson’s Disease clinical signs if current treatment is withdrawn; 6. Patient is willing to adhere to protocol requirements as evidenced by written, informed consent.
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E.4 | Principal exclusion criteria |
Patients meeting any of the following exclusion criteria either at Day 0 or during the study will not be enrolled or will be immediately excluded from the study, as appropriate: 1. Patient has a history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk, including bronchospasm or lung disease, clinically significant cardiac arrhythmias and/or myocardial ischemia; 2. Patient has a neurological condition which masks or mimics the signs and symptoms of Parkinson’s Disease 3. Patient has clinically significant laboratory abnormalities including liver enzyme elevation greater than twice the upper limit of normal; 4. Patients who are CYP2D6 poor metabolizer genotype as determined by a genetic blood sample. This is to prevent the possibility of toxic levels of study drug occurring in patients 5. Patient is unable to be treated with levodopa/carbidopa alone or with a single, relatively short-acting dopamine agonist; 6. Patient is taking a prohibited concomitant medication; 7. Patient has not been using an adequate contraceptive method for the last 30 days, or is not at least one year post-menopausal (if female); 8. Patient is pregnant or breastfeeding; 9. Patient has cognitive impairment; 10. Patient has participated in a clinical study with an investigational drug within the last 30 days; 11. Patient has a condition (such as active drug or alcohol abuse) that, in the opinion of the investigators, would interfere with compliance or safety;
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measures will be: - The number of subjects who have a minimum effective dose (MED) for each dose level. - Repeated measures analysis of co-variance to determine, for each patient, differences between doses of FPFS-1169 with regard to elements from the Unified Parkinson's Disease Rating Scale (UPDRS) and differences between doses of FPFS-1169 with regard to elements of the quantitative motor assessments.
The secondary outcome measures will be: - The primary safety assessment data will be the recording of the adverse event data - The secondary safety assessment variables are the vital signs (blood pressure, pulse, ECG parameters, local tolerability data and clinical laboratory data.
The primary endpoints are: - Adverse events - Unified Parkinson's Disease Rating Scale (UPDRS) - Quantitative motor assessments - Injection Site Tolerability Assessments - Vital Signs - ECG - Physical examination, including complete neurological evaluation - Laboratory safety data |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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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The end of the trial is defined as the last visit of the last subject |
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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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |