Treatment of Parkinson's Disease MedDRA version: 8.0 Classification code 10029205
Conditions
Interventions
Product Name: FPFS-1169
Pharmaceutical Form: Solution for injection
INN or Proposed INN: R-(-)-1-(benzofuran-2-yl)-2-propylaminopentane hydrochloride
CA
Sponsors
Fujimoto Pharmaceutical Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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 Patient should show typical Parkinson’s Disease clinical signs if current treatment is withdrawn; 6.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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the minimum effective dose (MED) and corresponding plasma concentrations of subcutaneous injections of FPFS-1169 in Parkinson’s disease patients.; Secondary Objective: 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. ; 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 | — |
Countries
United Kingdom
Outcome results
None listed