Titan Pharmaceuticals has started patient treatment in a Phase I/II clinical trial of ropinirole subdermal implant to treat the signs and symptoms associated with idiopathic Parkinson’s disease.
Ropinirole is a dopamine agonist available as an oral formulation for treating Parkinson’s disease symptoms and restless leg syndrome.
To avoid the side effects caused due to fluctuating levels of oral medication, the firm is developing ropinirole implant using its ProNeura long-term, continuous drug delivery technology.
Continuous and non-fluctuating delivery of ropinirole HCL is expected to reduce the serious motor problems observed in certain patients administered with oral daily formulations of the medication.
The open-label, sequential, dose escalation Phase I/II trial will primarily investigate the safety, tolerability and pharmacokinetic profile of the implant.
Designed to enrol around 20 patients at three US sites that specialise in Parkinson’s disease treatment, the trial will be carried out over a period of up to three months.
The primary objectives of the trial further include assessment of potential efficacy signals through established disease-specific assessment scales.
Titan Pharmaceuticals executive vice-president and chief development officer Kate Beebe said: “We believe our ropinirole implant has the potential to offer patients substantial benefits over existing daily and more frequently dosed oral formulations of ropinirole, and we look forward to continuing to enrol subjects in this study.”
Patients who are currently on a stable dose of oral ropinirole in combination with L-dopa will be switched to ropinirole implants + L-dopa for the trial duration.
While the initial results from the first cohort of patients are expected in the first quarter of next year, the trial is scheduled to complete by the year end.