A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)
Public ClinicalTrials.gov record NCT02549092. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to examine the effect of LCIG relative to that of OMT on NMS associated with PD.
Study identification
- NCT ID
- NCT02549092
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 89 participants
Conditions and interventions
Conditions
Interventions
- Optimized Medical Treatment Drug
- Levodopa-Carbidopa Intestinal Gel Drug
- Nasojejunal (NJ) tube Device
- Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube Device
Drug · Device
Eligibility (public fields only)
- Age range
- 30 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 25, 2015
- Primary completion
- May 13, 2020
- Completion
- Nov 17, 2022
- Last update posted
- Nov 27, 2023
2015 – 2022
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Parkinson's and Movement /ID# 161596 | Fountain Valley | California | 92708 | — |
| Boca Raton Regional Hospital /ID# 200056 | Boca Raton | Florida | 33486 | — |
| University of Florida Neurolog /ID# 168699 | Jacksonville | Florida | 32209 | — |
| Parkinson's Disease Treatment Center of Southwest Florida /ID# 168085 | Port Charlotte | Florida | 33980 | — |
| Rush University Medical Center /ID# 168088 | Chicago | Illinois | 60612 | — |
| St. Luke's Health System /ID# 168706 | Kansas City | Missouri | 64111 | — |
| Central Texas Neurology Consul /ID# 168087 | Round Rock | Texas | 78681 | — |
| Inland Northwest Research /ID# 200113 | Spokane | Washington | 99202-1342 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02549092, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 27, 2023 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02549092 live on ClinicalTrials.gov.