CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 630 enrolled
Drug / intervention
IR CD-LD +3 moredrug
Likely dose
IPX203 extended-release carbidopa-levodopa (specific dose not specified in protocol excerpt)AI-extracted
Key inclusion· 6
  • ✓Age ≥40 years with Parkinson's disease diagnosed per UK Parkinson's Disease Society Brain Bank Diagnostic Criteria
  • ✓Currently on stable carbidopa-levodopa regimen for ≥4 weeks with responsive motor symptoms
  • ✓Experiencing motor fluctuations with predictable Off periods
  • ✓Hoehn and Yahr stage 1-4 in the On state (MDS-UPDRS Part III)
Key exclusion· 10
  • ✕Prior neurosurgical treatment for PD or planned/anticipated neurosurgery during study
  • ✕History of gastrectomy, proximal small-bowel resection, or bariatric surgery
  • ✕History of upper gastrointestinal hemorrhage with peptic ulcer disease in past 5 years
  • ✕Glaucoma with elevated intraocular pressures despite medical management

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03670953
NCT03670953Phase 3Completed
CompareCT.gov

A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations

Impax Laboratories, LLC·interventional·Posted Sep 14, 2018·Updated Feb 9, 2023

In Brief

A Phase 3 clinical trial evaluating IR CD-LD, IPX203 ER CD-LD, and 2 other interventions for Parkinson's Disease (Disorder). Completed, enrolled 630 participants across 108 sites in 8 countries.

Detailed Summary

To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced participants with Parkinson's disease (PD) who have motor fluctuations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease (Disorder)
CountriesCzechia, France, Germany, Italy, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 14, 2018
Enrollment StartNov 6, 2018
Primary CompletionJun 15, 2021
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.8 years ago

Interventions

IR CD-LDdrug

Active comparator - IR CD-LD

IPX203 ER CD-LDdrug

Investigational formulation - ER CD-LD

Placebo Matching IPX203other

Double dummy placebo capsules

Placebo Matching IR CD-LDother

Double dummy placebo tablets