CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Sinemet +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03007888
NCT03007888Phase 2Completed
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A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease

Impax Laboratories, LLC·interventional·Posted Jan 2, 2017·Updated Jun 6, 2022

In Brief

A Phase 2 clinical trial evaluating Sinemet and IPX203 for Advanced Parkinson's Disease. Completed, enrolled 28 participants across 11 sites.

Detailed Summary

Primary Objective: To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD). Secondary Objectives: To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD. To compare the efficacy of IPX203 with IR CD-LD following multiple doses. To evaluate the safety of IPX203.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Parkinson's Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2, 2017
Enrollment StartNov 14, 2016
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.5 years ago

Interventions

Sinemetdrug

Immediate Release Tablet containing carbidopa-levodopa flexible dosing

IPX203drug

Extended Release capsules containing carbidopa-levodopa flexible dosing