A Proof of Concept Study to Determine the Minimum Effective Dose and to Assess the Efficacy and Safety of Subcutaneous Injections of FPFS-1169 in Parkinson's Disease Patients - Parkinson's Disease FPFS-1169 Proof of Concept Study (RD639/24201)

Phase 1

• Conditions: Treatment of Parkinson's Disease; MedDRA version: 8.0 Classification code 10029205

• Registration Number: EUCTR2006-000361-11-GB
• Lead Sponsor: Fujimoto Pharmaceutical Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-01
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

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 Patient should show typical Parkinson’s Disease clinical signs if current treatment is withdrawn;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

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified