The Phase 1/2 study (NCT03250117) is taking place at three clinical sites in the U.S. that specialize in Parkinson’s research. Researchers expect to enroll 20 Parkinson’s patients who are currently taking oral ropinirole (Requip, manufactured by GlaxoSmithKline), along with L-DOPA, who will switch to subdermal ropinirole implants for three months.
The study’s primary goals are to characterize how much ropinirole is released in the blood stream during the three months, along with the implant’s safety and tolerability. It will also look for signs of efficacy using established disease-specific assessment scales.
The four arms of the open-label study will receive increasing doses of the implant, up to four implants.
Initial data from the first arm is anticipated in the first quarter of 2018. The study is expected to be completed by the end of 2018.
Ropinirole is a dopamine agonist, which mimics the effects of dopamine without first being converted in the brain from levodopa (L-DOPA) into dopamine. Levodopa and dopamine agonists are two different classes of drugs.
Requip is available in oral formulations to treat Parkinson’s symptoms and restless leg syndrome. It is often used in combination with L-DOPA to help control serious motor complications and dyskenesias (involuntary movements) that often patients often experience after continued, long-term L-DOPA treatment.
Studies have suggested that these complications are mostly associated with fluctuating medication levels, inherent in oral formulations.
“Patients on oral formulations of dopamine and dopamine agonists will often develop serious motor complications and dyskinesias,” Aaron Ellenbogen, the study’s principal investigator at the first trial site in Michigan, said in a press release.
“These complications are due to the daily pattern of peak-trough levels of medication in the blood, duration and severity of disease, and the requirement of higher doses of levodopa,” he added. “Providing a long-acting dopamine agonist with a flat pharmacokinetic profile can aid in reducing these complications.”
Titan’s ropinirole implants use the company’s ProNeura drug delivery technology, designed to enable the long-term, continuous delivery of the investigative drug. The implants do not treat the underlying cause of the disease, but continued delivery of ropinirole may potentially minimize the severe motor complications experienced by some patients on oral medications.
The Phase 1/2 study is currently recruiting participants. Both men and women ages 30 to 80 are eligible to participate. For more information on eligibility criteria and enrollment procedures, go to this link or contact Titan at 650-244-4990 or via email at ROPfirstname.lastname@example.org. Refer to the clinical trial identifier number NCT03250117.