Trials / Unknown
UnknownNCT04269642
SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's Disease
Phase IIa Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients With Early Parkinson's Disease
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 99 (estimated)
- Sponsor
- Peptron, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
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) 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PT320 2.0mg Placebo | PT320 2.0mg Placebo |
| DRUG | PT320 2.0 mg | Exenatide slowly released formulation |
| DRUG | PT320 2.5 mg | Exenatide slowly released formulation |
Timeline
- Start date
- 2020-03-19
- Primary completion
- 2021-09-29
- Completion
- 2021-12-31
- First posted
- 2020-02-17
- Last updated
- 2021-04-12
Locations
5 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04269642. Inclusion in this directory is not an endorsement.