SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's Disease

NCT04269642 | Unknown Phase 2

• 1 other identifier: PT320-201
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 5

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).

Conditions

Early Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Change of MDS-UPDRS part 3 score

  Change of MDS-UPDRS (Movement Disorder Society -Unified Parkinson's Disease Rating Scale ) part 3 score from baseline at 48 weeks. The MDS-UPDRS has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination) and Part IV (motor complications). The MDS-UPDRS consists of five measures, 0(normal) to 4(severe), according to each item, and is evaluated as the total score per part of Part 1 to 4. A 0 means there is no disability, and the higher the score, the more the disability is reflected.

  48 week

Secondary Outcomes (8)

• SNBR (specific to non-specific binding ratio) confirmed by PET scan

  0 and 48 weeks

• MDS-UPDRS part 3 score

  0, 24 and 60 weeks

• MDS-UPDRS part 1, 2 and 4 scores

  0, 24, 48 and 60 weeks

• K-PDQ-39 score

  0, 48 and 60 weeks

• MoCA-K score

  0, 24, 48 and 60 weeks

Other Outcomes (3)

• Pharmacokinetics test with blood

  0, 12, 24, 36, 48 and 60 weeks

• Pharmacokinetics test with CSF

  0, 12, 24, 36, 48 and 60 weeks

• Anti-exenatide antibodies test in blood

  0, 12, 24, 36, 48 and 60 weeks

Study Arms (3)

PT320 2.0mg Placebo

PLACEBO COMPARATOR

will be injected subcutaneously once a week for 48 weeks

Drug: PT320 2.0mg Placebo

PT320 2.0mg treatment 1

EXPERIMENTAL

will be injected subcutaneously once a week for 48 weeks

Drug: PT320 2.0 mg

PT320 2.5mg treatment2

EXPERIMENTAL

will be injected subcutaneously every two weeks for 48 weeks. (Actually, patients will be injected PT320 2.5 mg and placebo alternately once a week.)

Drug: PT320 2.5 mg

Interventions

PT320 2.0mg Placebo DRUG

PT320 2.0mg Placebo

PT320 2.0mg Placebo

PT320 2.0 mg DRUG

Exenatide slowly released formulation

PT320 2.0mg treatment 1

PT320 2.5 mg DRUG

Exenatide slowly released formulation

PT320 2.5mg treatment2

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peptron, Inc.: lead

Study Sites (5)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Min Ho Ihm

  Peptron, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: February 17, 2020
• Study Start: March 19, 2020
• Primary Completion: September 29, 2021
• Study Completion: December 31, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)