Phase 2 Study to evaluate the efficacy and safety of PT320 with early Parkinson’s disease
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0004652
- Lead Sponsor
- Peptron
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 99
1) Patient who is male or female aged 40-75 and is diagnosed with Parkinson’s Disease (using Queen Square Brain Bank criteria)
2) Patient who is diagnosed of Parkinson’s Disease less than 24 months prior to the screening
3) Patient who has a modified Hoehn and Yahr stage = 2. 5
4) Patient who has been taking L-dopa stable-dose less than 600 mg/day or who has not previously taken any medication for the treatment of Parkinson's Disease from 4 weeks prior to the screening.
5) Patient who is able to inject an Investigational Product by himself/herself or a his/her guardian.
6) Patient or legally acceptable representative who signs the informed consent form voluntarily and is able to comply with all study procedures.
1) Patient who is diagnosed or suspected to have Parkinson-plus syndromes (e.g., Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Diffuse Lewy Body Disease, and etc.)
2) Patient who has a BMI < 18.5 at screening
3) Patient who has known abnormalities on CT or MRI brain imaging that may have impact on the protocol compliance and/or PET scan
4) Patient who has dementia with MoCA-K = 22
5) Patient who has a history of severe heart failure (NYHA class III to IV), stroke, cerebral ischemic attack, or seizure within 1 year prior to screening; or a history myocardial infarction or unstable angina within 6 months prior to screening.
6) Patient who has severe liver disease or has AST or ALT level 3 times more than ULN at screening
7) Patient who has clinically significant depression [> 18 of Korean Beck Depression Inventory II score (K-BDI-II)]
8) Patient who has a history of brain surgery for any treatment of Parkinson's disease
9) Patient who has participated in any clinical trials for the treatment of Parkinson’s Disease within 3 months prior to screening
10) Patient who took exenatide within 90 days prior to randomization
11) Patient who has a history of gastroduodenal ulcer or gastroparesis within 3 months prior to administration of investigational product or is currently on medication for acute or chronic gastritis
12) Patient who has severe kidney function injury (creatinine clearance < 30 ml/min)
13) Patient who has a history of pancreatitis
14) Patient who has type 1 or type 2 diabetes or HbA1c = 6.5% at screening
15) Patient who has a history or suspected to thyroid cancer or multiple endocrine adenomatosis
16) Patient who has known or suspected intolerance in PET scan or fluoropropyl-CIT (18F)
17) Woman childbearing potential who doesn’t agree to use the medically acceptable methods of contraception* during this study and up to 24 weeks after the last injection of investigational product
18) Woman who is pregnant or breastfeeding
19) Patient who has a history of hypersensitivity reactions to any ingredients of investigational product
20) Patient who is not eligible for the study at the discretion of the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of MDS-UPDRS part 3 score
- Secondary Outcome Measures
Name Time Method Change of SNBR (specific to non-specific binding ratio) confirmed by PET scan;Change of MDS-UPDRS part 3 score;Changes of MDS-UPDRS part 1, 2 and 4 scores;Change of K-PDQ-39 score;Change of MoCA-K score;Change of K-NMSS score;Each percentage of subjects and changing patterns in modified Hoehn and Yahr stage;Change of L-dopa’s dosage and percentage of subjects who have L-dopa treatment