At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 89 enrolled
Drug / intervention
Optimized Medical Treatment +3 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.
An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) THerapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects With Advanced Parkinson's Disease - INSIGHTS Study
In Brief
A Phase 3 clinical trial evaluating Optimized Medical Treatment, Levodopa-Carbidopa Intestinal Gel, and 2 other interventions for Advanced Parkinson's Disease. Completed, enrolled 89 participants across 38 sites in 9 countries.
Detailed Summary
The primary objective of this study is to examine the effect of LCIG relative to that of OMT on NMS associated with PD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Parkinson's Disease
CountriesAustralia, Canada, Germany, Greece, Italy, South Korea, Spain, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartOct 2015
Primary CompletionMay 2020
Study CompletionNov 2022
TodayJul 2026
First PostedSep 15, 2015
Enrollment StartOct 26, 2015
Primary CompletionMay 14, 2020
Study CompletionNov 18, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 10.8 years ago
Interventions
Optimized Medical Treatmentdrug
Oral, sublingual or transdermal anti-PD medications and medications to treat NMS per Investigator discretion and/or in accordance with approved product label of the prescribed medications.
Levodopa-Carbidopa Intestinal Geldrug
Nasojejunal (NJ) tubedevice
optional prior to PEG-J placement
Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tubedevice