EASE LID Study: Drug to Treat Levodopa Induced Dyskinesia
This is a multi-center, randomized, double-blind, placebo-controlled, study to evaluate the effectiveness and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, taken once nightly at bedtime for the treatment of levodopa induced dyskinesia (LID) in subjects with Parkinson's disease (PD). ADS-5102 is an extended release (ER) formulation of amantadine and is designed to be taken by mouth once nightly at bedtime, providing a slow release of amantadine into the bloodstream. It is hoped that the low amount of drug in the bloodstream in the evening and overnight may reduce some side effects, including difficulty sleeping and vivid dreams, which can occur with use of immediate-release amantadine. Up to 6 subjects are anticipated to be enrolled in this study at Rush with up to 90 subjects study-wide. Subject participation is anticipated to last up to 4 months with the opportunity to participate in an open-label extension study.
In order to participate you must meet the following criteria:
- Be 30 years to 85 years old.
- Sign a current IRB/REB/IEC-approved informed consent form.
- Have Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria.
- Be on a stable regimen of antiparkinson's medications for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation.
- Follow diary training, the subject is willing and able to understand and complete the 24-hour PD home diary (caregiver/study partner assistance allowed).
- Confirm that any other current and allowed prescription/nonprescription medications and/or nutritional supplements that are taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening, and you must be 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 neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation).
- Have a history of seizures within 2 years prior to screening.
- Have a history of stroke or transient ischemic attack (TIA) within 2 years prior to screening.
- Have a history of cancer within 5 years prior to screening, with the following exceptions: Adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer.
- Have a presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening.
- Are female and are pregnant or lactating.
- If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment.
- Had treatment with an investigational drug or device within 30 days prior to screening.
- Had treatment with an investigational biologic within 6 months prior to screening.
- Are currently participating in another clinical trial.
This is a partial list of inclusion and exclusion criteria.