EUCTR2018-002234-21-ESActive, not recruitingPhase 1
AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Impax Laboratories, LLC
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •1. Successfully completed Study IPX203-B16-02;
- •2. Able to provide written informed consent prior to the conduct of any study-specific procedures;
- •3. Female subjects of childbearing potential must have a negative urine pregnancy test at the baseline visit (Visit 1);
- •4. Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
Exclusion Criteria
- •1. Intends to use any doses of Rytary or Duopa during this study;
- •2. Plans to use an investigational treatment other than IPX203 during the course of this study;
- •3. Neurosurgical ablation treatment for PD is planned or anticipated during the study period. Implantation of a deep brain stimulator (DBS) for the treatment of PD is permitted during this study;
- •4. Subjects who, in the opinion of the clinical investigator, should not participate in the study.
Investigators
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