Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Impax Laboratories, LLC
IPX066 is intended for chronic treatment of motor symptoms for all stages of PD. This study is designed to enroll subjects who have successfully completed one of the following studies of IPX066:
* IPX066-B08-05 (A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease)
* IPX066-B08-11 (A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa - Levodopa)
* IPX066-B09-02 (A Study to Evaluate the Safety and Efficacy of IPX066 in Advanced Parkinson's Disease)
All participants will be given IPX066 for 9 months.
Age
30–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02.
2. In the opinion of the Investigator, the Parkinson's disease diagnosis is still valid and the subject remains eligible for LD therapy.
You may not be if
1. Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment.
2. Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation.
3. Received within 4 weeks prior to Baseline Visit or planning to take during study participation: nonselective monoamine oxidase (MAO) inhibitors (with the exception of rasagiline).
4. In the opinion of the Investigator, should not participate in the study.
