None listed
Conditions
Brief summary
This study is an open-label extension study to Protocol ZYN2-CL-03 (STAR1). The study aims to evaluate the long term effectiveness, safety, tolerability and blood levels of twice daily ZYN002 in addition to regular seizure medication for 24 months in up to 180 adults with partial onset seizures (POS) who have participated in study ZYN2-CL-03. This will be done by analysing a daily seizure and skin irritation diary, drug levels in the blood at various times following drug administration, and side effects. Skin at the application sites will be checked to see if there is any irritation or reactions present after applications. Who is if for? You may be eligible to join this study if have completed the 12 weeks of study treatment on protocol ZYN2-CL-03. Study details: All participants will administer ZYN002 transdermal gel twice daily for 24 months. What does study participation involve? Eligible patients can immediately transition after completing day 84 (at Week 12) of the double-blind study, ZYN2-CL-03, to the open label study, ZYN2-CL-004. All participants in this extension study will receive active ZYN002. This could be the first time a participant receives ZYN002, depending on which treatment they received in the previous study (ZYN2-CL-03). After pre-dosing procedures are completed, patients will start study medication (Day 1). The first dose of study drug will be applied by the patient at this visit. Patients will be required to visit the clinic at Week 2 and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, Adhoc and End of Study to have study procedures completed. Participants will continue to record their seizure frequency and type in their daily diary. At the clinic visits the following procedures will occur: blood sampling; review of daily diary, medications, adverse events and skin irritation; measurement of blood pressure, heart rate, breathing rate and temperature ; suicide risk; and possibly, a brief physical and neurological exam, pregnancy tests (females only, if applicable) and an ECG. Participants withhold their morning application until after blood sample collection at these visits. Additional out-patient visits may be required if there is skin irritation present at the application site.
Interventions
ZYN002 will be administered as a transdermal gel for 24 months with all patients starting at ZYN002 - CBD 195 mg every 12 hours (390 mg daily), with the option after Month 1 to either increase or reduce the dose of ZYN002 as determined by the investigator. The dose may be increased to 292.5 mg every 12 hours (585 mg daily). After one month at the 585 mg daily dose, the Investigator has the option to increase the dose to 390 mg every 12 hours (780 mg daily).
After the Month 24 visit, or the last
ZYN002 will be administered as a transdermal gel for 24 months with all patients starting at ZYN002 - CBD 195 mg every 12 hours (390 mg daily), with the option after Month 1 to either increase or reduce the dose of ZYN002 as determined by the investigator. The dose may be increased to 292.5 mg every 12 hours (585 mg daily). After one month at the 585 mg daily dose, the Investigator has the option to increase the dose to 390 mg every 12 hours (780 mg daily). After the Month 24 visit, or the last visit if the patient terminates early from the study, patients will have either a one week or two week taper period. Patients will have their dose reduced by 50% the first week and another 50% the second week and then treatment will be discontinued. As applicable, ZYN002 gel will be applied to the skin of both the right and left shoulder and/or upper arms and right/left thighs. Participants will bring used and unused sachets to each visit for site to check treatment compliance.
Sponsors
Zynerba Pharmaceuticals Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Must have completed 12 weeks of the ZYN2-CL-03 protocol, with greater than 95% compliance with study drug application and daily seizure and skin check diaries. 2. Patient agrees to abide by all study restrictions and comply with all study procedures. 3. Patient must be adequately informed of the nature and risks of the study and give written informed consent on Day 1. 4. In the Investigator’s opinion, the patient is reliable and is willing and able to comply with all protocol requirements and procedures. 5. Females of child-bearing potential must have a negative urine pregnancy test at Day 1 and at Months 1, 2, 3, 6, 9, 12, 15, 18, 24, Adhoc and End of Study. Females of child-bearing potential and male patients with a partner of child-bearing potential must continue to use an acceptable method of contraception until at least 3 months after the last dose of study drug.
Exclusion criteria
1. Patient is receiving any investigational drugs or using any experimental devices. 2. Patient has an ongoing serious adverse event (SAE) or has experienced a SAE in ZYN3-CL-03 that in the opinion of the investigator should exclude them from participation. 3. Patient has been less than 95% compliant with study medication in ZYN2-CL-03. 4. Patient demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.
Outcome results
None listed