A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease

Status: 
Recruiting
Clinicaltrials.gov identifier: 
NCT03655236
Sponsor: 
Sun Pharma Advanced Research Company Limited
Enrollment: 
504
Study Design: 
This is a Phase 2 multicentre, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of K0706 among individuals with early PD. The study plans to include dopaminergic drug naïve individuals aged 50 years and above with a clinical diagnosis of probable PD using the MDS clinical diagnostic criteria. The PwP should be projected to not require dopaminergic medications for nine months. Only MAO-B inhibitor usage is allowed at the time of inclusion. Standard exclusionary criteria apply. The drug is administered orally once-daily, and participants will be assigned to one of the three arms: 1. Low dose K0706; 2. High dose K0706; 3. Placebo. The study visits will include at least 1 screening visit, 10 study treatment visits, and 1 follow-up visit 4 weeks post final study visit. The study is being conducted across 79 centers in the USA and Europe.
Rationale: 
The primary outcome measure is the change from baseline in the sum of MDS-UPDRS parts II and III at 40 weeks. The secondary outcome measure will assess the change at 40 weeks from baseline in the following: 1. MDS-UPDRS; 2. Time to initiation of symptomatic treatment; 3. Health-related quality of life as measured by the European quality of life questionnaire 5 lev-el version; 4. Clinician global impression severity; 5. Parkinson’s disease- autonomic questionnaire; 6. Level of K0706. The study will also include other exploratory measures, including effect of the drug on the DaT Scan, Skin biopsy, blood, and CSF levels of K0706. Following exploratory measures will be included: 1. Effect of the active drug on Dopamine Transporter Single Photon Emission Computed Tomog-raphy (DaT SPECT); 2. CSF K0706 levels of progression.
Comments: 
No preclinical data specifically for K0706 or Vodobatinib were found in the literature. According to the company press release, phase 1 studies report a safe profile and CNS presence. We await the efficacy data from the ongoing trial.