Phase 3
Completed N=617
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
Source: ClinicalTrials.gov NCT01096186 ↗Enrolled (actual)
617
Serious AEs
7.0%
Results posted
Mar 2016
Primary outcomePrimary: Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III — 26.4 units on a scale
Summary
The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III |
26.4 | — |
| SECONDARY Total UPDRS Parts I-IV |
30.5 | — |
| SECONDARY Patient Global Impression (PGI) |
5.4 | — |
Eligibility Criteria
Inclusion Criteria
- Each subject must meet the following inclusion criteria in order to be enrolled in the study:
- Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02.
- In the opinion of the Investigator, the Parkinson's disease diagnosis is still valid and the subject remains eligible for LD therapy.
Exclusion Criteria
- Each subject must be free of the following exclusion criteria in order to be enrolled in the study:
- Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment.
- Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation.
- 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).
- In the opinion of the Investigator, should not participate in the study.
Data sourced from ClinicalTrials.gov (NCT01096186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.