Status:
Active
Clinicaltrials.gov identifier:
Sponsor:
Amarantus BioScience Holdings, Inc.
Enrollment:
60
Study Design:
This is a double blind, placebo-controlled, crossover, dose range finding interventional study designed to assess the safety, tolerability, and efficacy of Eltoprazine on dyskinesia in PD participants. They are exploring 3 treatment doses and will assess their efficacy as compared to the placebo on the severity of dyskinesia, parkinsonian symptoms and participant function along with safety and tolerability. The study uses standard scales as noted below along with motion sensors and electronic diaries. The inclusion criteria require individuals between 30 to 85 years of age with a diagnosis of PD of at least 3 years duration and should be on stable dose of levodopa for 4 weeks prior to screening visit. The dyskinesia is required to be: 1. moderate to severely disabling; 2. present during 25% of the waking day on an average; and 3. present for at least 3 months prior to study entry. Standard exclusionary criteria are applied. Participants with surgical treatment for PD namely DBS are not blindly excluded but will be, if the procedure was done within the last 6 months of study inclusion or is planned during the study. There are 4 study arms as noted here, all with dosing for 3 weeks: 1. Eltoprazine HCl 2.5mg BID (5mg/day); 2. Eltoprazine HCl 5mg BID (10mg/day); 3. Eltoprazine 7.5mg BID (15mg/day); 4. Placebo capsules BID. Participants will be randomly assigned to each of the 4 arms. They will complete the 3-week treatment cycle before crossing over to the next study arm. The study is being conducted in USA at the Parkinson’s Disease and Movement Disorders Center at Boca Raton, FL.
Rationale:
The primary outcome measure is the change in the total UDysRS score. This will be assessed at the end of each treatment period on days 21, 42, 63 and 84. Secondary outcome measures will include: 1. Effect on PD motor symptoms as assessed by MDS-UPDRS, participant diaries and physiological meas-urement using the motion sensor system after 84 days; 2. Change in dyskinesia severity using the physiological motion sensor system after 84 days; 3. Participant function using the questionnaires in MDS-UPDRS and UDyRS to quantify dyskinesia and par-kinsonian motor symptoms. This will also be assessed after 84 days; 4. Lastly, safety and tolerability as assessed by adverse events, physical and neurological exams, safe labor-atory values, vital signs and ECG. This will be assessed after 94 days.
Comments:
The molecule carries potential for meaningful benefit in dyskinesia. The design of the Phase 1/2a study limits any effective assessment of efficacy. In 2016, the US FDA granted the molecule orphan drug designation status for PD. Since 2017, Eltoprazine’s development has been handled by Elto Pharma, Inc., a joint venture between Amanrantus and PsychoGenics. Elto Pharma recently entered into agreement with Coeptis Pharmaceuticals, Inc. regarding further development. Though the results from the phase 2b study were expected by now, given the delay, we will have to wait to find out whether the molecule is truly efficacious for dyskinesia without compromising the levodopa benefits.
