Clinical Trial 13916

Boca Raton, FL 33486

Study Summary:

It takes a steady hand to manage life with Parkinson’s disease.

If you have been diagnosed with early or advanced stage Parkinson’s disease, you may want to learn more about the TANDEM clinical trials.

The TANDEM trials are evaluating an oral, once-a-day medication to see if it is safe and effective for the treatment of Parkinson’s disease.

Why are these trials taking place?

Most commonly diagnosed in older patients, Parkinson’s disease currently has no cure. Doctors typically prescribe drugs like dopamine and L-dopa to help control some of the symptoms, but these drugs often lose their effectiveness after extended use. Because there is no cure and current treatment options tend to lose effectiveness over time, new treatments for Parkinson’s are needed today.

In the TANDEM trials, doctors want to learn more about a medication called ropinirole prolonged release (PR). Developed for the treatment of early and advanced Parkinson’s disease, ropinirole PR may allow patients to take only one dose a day to treat their condition. This trial may also provide doctors with a better understanding of patient responses to ropinirole PR when it is taken in combination with L-dopa.

Who can participate?

To pre-qualify for a TANDEM trial, you must be:

  • At least 30 years of age
  • Diagnosed with early stage or advanced stage Parkinson’s disease
  • Receiving L-dopa for no more than 3 months prior to the trial (if early stage)
  • Receiving a stable dose of L-dopa for at least 4 weeks prior to the trial, yet still experiencing Parkinson’s disease symptoms (if advanced stage)
There are other eligibility criteria that the study doctor or staff will review with you.

All trial-related visits, tests, and treatments will be provided to participants at no cost. In addition, reimbursement for travel may be provided.

What do the trials involve?

If you choose to participate, you will be asked to:
  • Sign an informed consent document before beginning any study-related activities
  • Attend a screening visit to determine eligibility
  • Have a physical examination, electrocardiogram (ECG), and other study-related tests and assessments
  • Patients with advanced Parkinson’s will also be asked to keep a trial diary over the 3 days immediately before a scheduled clinic visit
If you are eligible and agree to participate, you will be randomly placed into one of six treatment groups.

Five groups will be given ropinirole PR tablets, and one group will receive placebo tablets, which look like ropinirole PR, but contain no active ingredients. You will have a five in six chance of receiving treatment with ropinirole PR.

Depending on the stage of your Parkinson’s disease, trial participation will last between 29 and 33 weeks.

What are the risks and benefits?

Your health and well-being will be monitored during the trial. As with any clinical trial, your Parkinson’s symptoms may or may not improve as a result of your participation. Ropinirole PR has been studied in Parkinson’s patients before and has been shown to be effective in patients with early and late stage Parkinson’s. It is currently approved in the United States, Canada, South Africa, South Korea, Chile, and several European countries.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.