EUCTR2009-017182-38-PLActive, not recruitingNot Applicable
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Impax Laboratories, Inc.
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •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.
Investigators
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