Motor fluctuations in advanced Parkinson’s disease
Conditions
Brief summary
The primary endpoint is the change in good ON time at Week 12 compared to baseline for IPX203 versus IR LD/CD (>1 hour; ≤1 hour)
Detailed description
Change from baseline in OFF time at Week 12 (key secondary), Change from baseline in ON time, change from baseline in ON time with dyskinesia, change from baseline in ON time with troublesome dyskinesia, change from baseline in ON time with non-troublesome dyskinesia, and change from baseline in ON time without dyskinesia (all derived from the Parkinson’s disease [PD] diary), Change from baseline scores for the clinical outcome assessments listed in the protocol.
Interventions
DRUGH006629
DRUGLEVODOPA AND DECARBOXYLASE INHIBITOR
Sponsors
Zambon Biotech S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in good ON time at Week 12 compared to baseline for IPX203 versus IR LD/CD (>1 hour; ≤1 hour) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in OFF time at Week 12 (key secondary), Change from baseline in ON time, change from baseline in ON time with dyskinesia, change from baseline in ON time with troublesome dyskinesia, change from baseline in ON time with non-troublesome dyskinesia, and change from baseline in ON time without dyskinesia (all derived from the Parkinson’s disease [PD] diary), Change from baseline scores for the clinical outcome assessments listed in the protocol. | — |
Countries
Italy, Poland, Spain
Outcome results
None listed