Status:
Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Peptron Inc.
Enrollment:
99
Study Design:
This is a multi-centre (3 locations) randomised, double-blind, placebo-controlled, parallel group study. There are 3 arms – placebo; PT320 2.0mg once weekly; and PT320 2.5mg every 2 weeks with placebo administered every other week.
Rationale:
The primary outcome measure is motor function as measured by MDS-UPDRS part 3 at baseline and 48 weeks. Secondary outcome measures are: 1. Specific to non-specific binding ratio (SNBR) by PET scan at baseline and 48 weeks; 2. MDS-UPDRS part 3 score at 0, 24 and 60 weeks; 3. MDS-UPDRS parts 1,2 and 4 at baseline, 24,48 and 60 weeks; 4. Korean PD Questionnaire-39 at 0, 48 and 60 weeks; 5. Montreal cognitive assessment-Korean (MoCA-K) at baseline, 24,48 and 60 weeks; 6. Korean-non-motor symptoms scale (K-NMSS) at baseline, 24,48 and 60 weeks; 7. The percentage of subjects in each modified Hoehn and Yahr stage at baseline, 24,48 and 60 weeks; 8. Change in levodopa dosage at baseline, 2, 4, 8, 12, 24, 36, 48 and 60 weeks. This outcome measure is the starting time of levodopa treatment and the percentage of subjects taking levodopa. The study will also measure pharmacokinetic parameters in plasma and CSF, together with anti-exenatide antibodies, at baseline, 2, 12, 24, 36, 48 and 60 weeks.
Comments:
The inclusion criteria are for PwP between the ages of 40 and 75 diagnosed in the previous 2 years. They may already be on dopaminergic therapy (less than 600mg levodopa per day) or not yet have started. The Hoehn and Yahr stage must be <2.5.
The Bydureon formulation of exenatide is already a sustained release product, enabling weekly dosing. The Peptron product will need to prove superiority in efficacy, or sufficiently better convenience, to be clinically competitive.
