Status:
UNKNOWN
SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's Disease
Lead Sponsor:
Peptron, Inc.
Conditions:
Early Parkinson's Disease
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief Summary
This study is to evaluate the safety and efficacy of sustained release (SR)-Exenatide (PT320, Q1W and Q2W) in the treatment of patients with early Parkinson's disease (PD).
Detailed Description
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel comparison, phase IIa clinical study to evaluate the efficacy and safety of sustained release (SR)-Exenatide (PT320)...
Eligibility Criteria
Inclusion
- Patient who is male or female aged 40-75 and is diagnosed with Parkinson's Disease (using Queen Square Brain Bank criteria)
- Patient who is diagnosed of Parkinson's Disease less than 24 months prior to the screening
- Patient who has a modified Hoehn and Yahr stage ≤ 2. 5
- 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.
- Patient who is able to inject an Investigational Product by himself/herself or a his/her guardian.
- Patient or legally acceptable representative who signs the informed consent form voluntarily and is able to comply with all study procedures
Exclusion
- 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.)
- Patient who has a BMI \< 18.5 at the screening
- Patient who has known abnormalities on CT or MRI brain imaging that may have an impact on the protocol compliance and/or PET scan
- Patient who has dementia with MoCA-K ≤ 22
- 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.
- Patient who has severe liver disease or has AST or ALT level 3 times more than ULN at the screening
- Patient who has clinically significant depression \[\> 18 of Korean Beck Depression Inventory II score (K-BDI-II)\]
- Patient who has a history of brain surgery for any treatment of Parkinson's disease
- Patient who has participated in any clinical trials for the treatment of Parkinson's Disease within 3 months prior to screening
- Patient who took exenatide within 90 days prior to randomization
- 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
- Patient who has severe kidney function injury (creatinine clearance \< 30 ml/min)
- Patient who has a history of pancreatitis
- Patient who has type 1 or type 2 diabetes or HbA1c ≥ 6.5% at screening
- Patient who has a history or suspected to thyroid cancer or multiple endocrine adenomatosis
- Patient who has known or suspected intolerance in PET scan or fluoropropyl-CIT (18F)
- 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
- \*Medically acceptable methods of contraception: oral contraceptives, intrauterine contraceptive devices, vasectomy for male partner, barrier method \[condom, spermicidal foam/gel/film/cream/suppository with sealed cap (diaphragm or cervix/bolt cap)\].
- Woman who is pregnant or breastfeeding
- Patient who has a history of hypersensitivity reactions to any ingredients of investigational product
- Patient who is not eligible for the study at the discretion of the investigator
Key Trial Info
Start Date :
March 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04269642
Start Date
March 19 2020
End Date
December 31 2021
Last Update
April 12 2021
Active Locations (5)
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1
Seoul National University Bundang Hospital
Seongnam-si, South Korea
2
Asan Medical Center
Seoul, South Korea
3
Samsung Medical Center
Seoul, South Korea
4
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, South Korea