Titan Treats First Parkinson’s Patient with Ropinirole Implant in Clinical Trial

Titan Treats First Parkinson’s Patient with Ropinirole Implant in Clinical Trial

The first patient has been treated in a clinical trial evaluating Titan Pharmaceuticalsropinirole implants, designed to treat the signs and symptoms of Parkinson’s disease.

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 ROP-001@titanpharm.com. Refer to the clinical trial identifier number NCT03250117.

3 comments

  1. Val Goldthorp says:

    I cannot believe that this trial is taking place.
    Has the Mayo Clinic study showing 1 in 3 men under 50 , and 1 in 4 other patients, taking a therapeutic dose of dopamine agonists develop catastrophic impulse control disorders, usually involving compulsive gambling or disordered , compulsive sexual activity….Had had no impact?
    Years and years of ruined lives, broken marriages and bankruptcies…well-documented on the Parkinson’s Forum and by neuros and neuropsychologists, successful legal actions in the USA….and now further extension of this life-destroying drug?

  2. Judy Kilpatrick says:

    I am thinking about this and am going to responding to it. — I have PD since 1995 (I think). It runs in my family. I have been on Requip since about 1995. I was in a study then. It was a blind test and I was on the Requip while others were on something else. I have been on Requip since I left the test. I am currently on Requip,03 and Sinement,25/100 and have never had anything except these two. I have also various medicines for various medicial conditions. Please respond and let me know
    about this and who is conduting this test.

  3. My husband has been taking ropinirole for about 20 days 1/2tablet of 1 mg twice a day his movement is better except when he tries to get his feet on the bed. His mind is more confused. Also added memantine 5 mg twice a day. Has been taking donepezil for about 4 years gabapentin 1 year carbidopa 25/100 2 three times away 50/200at bedtime. Warfarin ,hydralazine and metoprolol for blood pressure,finasteride for prostrate,furosemide for fluid.trazodone to sleep plus vitamins D3 folic acid b12 . Is this the best dosage for him.?

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