EUCTR2009-017182-38-LTActive, not recruitingNot Applicable
An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease
Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)0 sites500 target enrollmentStarted: April 26, 2010Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- 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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