Clinical Trial TitleStudy of how well a study drug called dipraglurant (ADX48621) works compared to placebo in patients with Parkinson’s disease (PD) and levodopa-induced dyskinesia (LID).
Clinical Trial Protocol Description:
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of the study drug in reducing LID compared to placebo in patients with PD and LID. Nationwide, 140 patients will be recruited for this study. At Rush University Medical Center we expect to recruit approximately 3 patients. The treatment will be assigned randomly.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are male or female, between 30 and 85 years of age.
- Have a diagnosis of Parkinson’s disease, per UK Parkinson’s Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria and are experiencing episodes of troublesome dyskinesia symptoms throughout the day.
- Have ambulatory or ambulatory-aided (e.g., walker or cane) ability while ON, so that you can complete the study assessments.
- Are on a stable regimen of antiparkinson’s medications for at least 30 days prior to screening, including a levodopa preparation administered not less than 3 times daily, and willing to continue the same doses and regimens during study participation.
You will be excluded from the study if any of the following criteria apply to you:
- Have a history of exclusively diphasic, off state, myoclonic, dystonic, or akathetic dyskinesia without peak dose dyskinesia.
- Have a history of other neurological disease that would affect motor function or cognition.
- Have a history of clinically significant hallucinations (visual, auditory, or any other type) associated with the PD or any underlying psychiatric illness.
This is a partial list of inclusion and exclusion criteria. All eligibility criteria must be met in order to participate in the study. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.