Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04269642
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Peptron, Inc.

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).

Condition or disease Intervention/treatment Phase
Early Parkinson's Disease Drug: PT320 2.0mg Placebo Drug: PT320 2.0 mg Drug: PT320 2.5 mg Phase 2

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) in the treatment of patients with early Parkinson's disease (PD).

Exenatide has been approved by the Food and Drug Administration (FDA) to treat patients with Type 2 Diabetes (T2D) and obesity. In addition, several research groups have confirmed that Exenatide has beneficial aspects due to the neuroprotective effects in neuronal cells in patients with PD. Peptron has developed a sustained-release (SR)-Exenatide, (PT320, Q1W and Q2W), which has shown a higher Blood-Brain Barrier (BBB) penetration rate and better patient compliance.

Thus, the objective of this study is to evaluate the effect of PT320 on symptom improvement and the inhibition of disease progression in the treatment of patients with early Parkinson's disease. Also, pharmacokinetic analysis of PT320 in blood cerebrospinal fluid (CSF) and exosome analysis of biomarkers related to Exenatide will be being tested, as exploratory measurements.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IIa Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients With Early Parkinson's Disease
Actual Study Start Date : March 19, 2020
Estimated Primary Completion Date : September 29, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
Placebo Comparator: PT320 2.0mg Placebo
will be injected subcutaneously once a week for 48 weeks
Drug: PT320 2.0mg Placebo
PT320 2.0mg Placebo

Experimental: PT320 2.0mg treatment 1
will be injected subcutaneously once a week for 48 weeks
Drug: PT320 2.0 mg
Exenatide slowly released formulation

Experimental: PT320 2.5mg treatment2
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
Exenatide slowly released formulation




Primary Outcome Measures :
  1. Change of MDS-UPDRS part 3 score [ Time Frame: 48 week ]

    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.



Secondary Outcome Measures :
  1. SNBR (specific to non-specific binding ratio) confirmed by PET scan [ Time Frame: 0 and 48 weeks ]
    Change of SNBR (specific to non-specific binding ratio) from baseline at 48 weeks, confirmed by PET scan

  2. MDS-UPDRS part 3 score [ Time Frame: 0, 24 and 60 weeks ]

    Change of MDS-UPDRS (Movement Disorder Society -Unified Parkinson's Disease Rating Scale ) part 3 scores from baseline at 24 and 60 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.


  3. MDS-UPDRS part 1, 2 and 4 scores [ Time Frame: 0, 24, 48 and 60 weeks ]

    Changes of MDS-UPDRS (Movement Disorder Society -Unified Parkinson's Disease Rating Scale ) part 1, 2 and 4 scores from baseline at 24, 48 and 60 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.


  4. K-PDQ-39 score [ Time Frame: 0, 48 and 60 weeks ]
    Change of K-PDQ-39 (korean-The Parkinson's Disease Questionnaires-39) score from baseline at 48 and 60 weeks. PDQ-39 is an assessment of Parkinson's disease and comprises a total of 39 questions. Based on the past month's experience, each item consists of a five-point scale of 0(never) to 4 (always) and is checked by the test subjects themselves. The total score of PDQ-39 is evaluated as a percentage of 0-100%, and as the score increases, the symptom becomes more severe.

  5. MoCA-K score [ Time Frame: 0, 24, 48 and 60 weeks ]

    Change of MoCA-K (Montreal Cognitive Assessment-Korean) score from baseline at 24, 48 and 60 weeks.

    MoCA-K is designed to evaluate mild cognitive disorders. The raters evaluate cognitive functions such as attention and concentration, memory, language, conceptual thinking, calculations, and orientation. The execution time takes about 10 minutes and is evaluated by the sum of the scores of each item. A perfect score of 30 points or more is considered normal.


  6. K-NMSS score [ Time Frame: 0, 24, 48 and 60 weeks ]

    Change of K-NMSS (Korean-Non Motor Symptoms Scale) score from baseline at 24, 48 and 60 weeks.

    K-NMSS evaluates non-motorative symptoms of Parkinson's disease. It consists of a total of 30 questions, separated by nine aspects: cardiovascular function, sleep/ fatigue, sexual function, and other non-motor symptoms. The evaluation period is evaluated based on the experience of the last month.

    For each aspect, the grade point is evaluated as the degree of severity (level 0-3) and frequency (1-4), and the evaluation score is obtained by multiplying the degree and frequency of severity.

    The K-NMSS has a range of 0-360 points, and the higher the score, the more severe the symptoms are judged.


  7. Each percentage of subjects and changing patterns in modified Hoehn and Yahr stage [ Time Frame: 0, 24, 48 and 60 weeks ]
    Percentage of subjects per modified Hoehn and Yahr stage and the changing patterns from baseline at 24, 48 and 60 weeks

  8. Change of the L-dopa dosage of subjects [ Time Frame: 0, 2, 4, 8, 12, 24, 36, 48 and 60 weeks ]
    Starting time of L-dopa treatment and percentage of subjects who have L-dopa treatment at each visit.


Other Outcome Measures:
  1. Pharmacokinetics test with blood [ Time Frame: 0, 12, 24, 36, 48 and 60 weeks ]
    Pharmacokinetics test will assess Cmax (Maxi mum Plasma Concentration) and Tmax (Time of Maximum Plasma Concentration) in blood (pre-dose, 12, 24, 36, 48 and 60 weeks)

  2. Pharmacokinetics test with CSF [ Time Frame: 0, 12, 24, 36, 48 and 60 weeks ]
    Pharmacokinetics test will assess Cmax (Maximum Plasma Concentration) and Tmax (Time of Maximum Plasma Concentration) in Cerebrospinal Fluid (CSF; pre-dose and 48 weeks only)

  3. Anti-exenatide antibodies test in blood [ Time Frame: 0, 12, 24, 36, 48 and 60 weeks ]
    Check if antibody of exenatide (PT320) is created



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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

Exclusion Criteria:

  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 the screening
  3. Patient who has known abnormalities on CT or MRI brain imaging that may have an 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 the 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

    *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)].

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269642


Contacts
Layout table for location contacts
Contact: Min Ho Ihm 82+ 423608851 ihmhjoy@peptron.co.kr
Contact: Jiwon Kim 82+ 423608821 gmh3088@peptron.co.kr

Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital Not yet recruiting
Seongnam-si, Korea, Republic of
Contact: Jong Min Kim, M.D.         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Sun Ju Chung, M.D.         
Principal Investigator: Sun Ju Chung, M.D.         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jin Hwan Cho, M.D.         
Principal Investigator: Jin Hwan Cho, M.D.         
Seoul Metropolitan Government Seoul National University Boramae Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Jee Young Lee, M.D.         
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Beom Seok Jeon, M.D.    82+ 220722876    brain@snu.ac.kr   
Principal Investigator: Beom Seok Jeon, M.D.         
Sponsors and Collaborators
Peptron, Inc.
Investigators
Layout table for investigator information
Study Director: Min Ho Ihm Peptron, Inc.
Layout table for additonal information
Responsible Party: Peptron, Inc.
ClinicalTrials.gov Identifier: NCT04269642    
Other Study ID Numbers: PT320-201
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases