Early Parkinson's DiseasePhase 2NCT04269642
SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's Disease
A Phase 2 study testing PT320 2.0 mg and PT320 2.5 mg in people with Early Parkinson's Disease, run by Peptron, Inc. at 5 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Early Parkinson's Disease
- What is being tested?
- PT320 2.0 mg and PT320 2.5 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 19 Mar 2020to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Seoul National University Bundang Hospital
Seongnam-si
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: Phase IIa Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients With Early Parkinson's Disease
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).
Read the 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 (GLP-1) 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.
- Conditions
- Early Parkinson's Disease
- Being tested
- PT320 2.0mg Placebo, PT320 2.0 mg, PT320 2.5 mg
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT320 2.0mg PlaceboDrug
PT320 2.0mg Placebo
PT320 2.0 mgDrug
Exenatide slowly released formulation
PT320 2.5 mgDrug
Exenatide slowly released formulation
| Study group | Role | What they receive |
|---|---|---|
| PT320 2.0mg Placebo | Placebo comparator | will be injected subcutaneously once a week for 48 weeks Receives: Drug: PT320 2.0mg Placebo |
| PT320 2.0mg treatment 1 | Experimental | will be injected subcutaneously once a week for 48 weeks Receives: 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.) Receives: Drug: PT320 2.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 week
Secondary outcomes (8)
SNBR (specific to non-specific binding ratio) confirmed by PET scan
Change of SNBR (specific to non-specific binding ratio) from baseline at 48 weeks, confirmed by PET scan
Measured: 0 and 48 weeks
MDS-UPDRS part 3 score
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.
Measured: 0, 24 and 60 weeks
MDS-UPDRS part 1, 2 and 4 scores
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.
Measured: 0, 24, 48 and 60 weeks
K-PDQ-39 score
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.
Measured: 0, 48 and 60 weeks
MoCA-K score
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.
Measured: 0, 24, 48 and 60 weeks
K-NMSS score
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.
Measured: 0, 24, 48 and 60 weeks
Each percentage of subjects and changing patterns in modified Hoehn and Yahr stage
Percentage of subjects per modified Hoehn and Yahr stage and the changing patterns from baseline at 24, 48 and 60 weeks
Measured: 0, 24, 48 and 60 weeks
Change of the L-dopa dosage of subjects
Starting time of L-dopa treatment and percentage of subjects who have L-dopa treatment at each visit.
Measured: 0, 2, 4, 8, 12, 24, 36, 48 and 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start19 Mar 2020
- Primary completion29 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peptron, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Ho Ihm, Study director, Peptron, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269642
- Sponsor's protocol ID
- PT320-201
- Status last verified
- Apr 2021
- First submitted
- 13 Jan 2020
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients With Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04269642
- Acronym / sponsor ID
- PT320-201
- Conditions
- Early Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Peptron, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 29 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) in the treatment of patients with early Parkinson's disease (PD).
Exenatide (GLP-1) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PT320 2.0mg Placebo | Placebo comparator | Drug: PT320 2.0mg Placebowill be injected subcutaneously once a week for 48 weeks |
| PT320 2.0mg treatment 1 | Experimental | Drug: PT320 2.0 mgwill be injected subcutaneously once a week for 48 weeks |
| PT320 2.5mg treatment2 | Experimental | Drug: PT320 2.5 mgwill be injected subcutaneously every two weeks for 48 weeks. (Actually, patients will be injected PT320 2.5 mg and placebo alternately once a week.) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PT320 2.0mg PlaceboPT320 2.0mg Placebo | Drug | PT320 2.0mg Placebo |
| PT320 2.0 mgExenatide slowly released formulation | Drug | PT320 2.0mg treatment 1 |
| PT320 2.5 mgExenatide slowly released formulation | Drug | PT320 2.5mg treatment2 |
Primary outcome
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.
8 secondary outcomes
SNBR (specific to non-specific binding ratio) confirmed by PET scan
Time frame: 0 and 48 weeks
MDS-UPDRS part 3 score
Time frame: 0, 24 and 60 weeks
MDS-UPDRS part 1, 2 and 4 scores
Time frame: 0, 24, 48 and 60 weeks
K-PDQ-39 score
Time frame: 0, 48 and 60 weeks
MoCA-K score
Time frame: 0, 24, 48 and 60 weeks
K-NMSS score
Time frame: 0, 24, 48 and 60 weeks
Each percentage of subjects and changing patterns in modified Hoehn and Yahr stage
Time frame: 0, 24, 48 and 60 weeks
Change of the L-dopa dosage of subjects
Time frame: 0, 2, 4, 8, 12, 24, 36, 48 and 60 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Ho Ihm study director
Peptron, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PT320 2.0 mg and PT320 2.5 mg in people with Early Parkinson's Disease, run by Peptron, Inc. at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of MDS-UPDRS part 3 score (time frame: 48 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.