Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02549092 · ClinicalTrials.gov registry record · Phase 3

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)

A Phase 3 study of Advanced Parkinson's Disease, sponsored by AbbVie.

Completed
Registry status
Phase 3
Development phase
89
Enrollment target
20
Study locations

NCT02549092: Completed Phase 3 study of Advanced Parkinson's Disease, sponsored by AbbVie.

NCT02549092 is a Phase 3 study of Advanced Parkinson's Disease that has completed, run by AbbVie. The registered enrollment target is 89 participants, below the 105-participant average among 3 other Advanced Parkinson's Disease trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02549092, a Phase 3 study of Advanced Parkinson's Disease, has completed, sponsored by AbbVie.

COMPLETED
Registry status
Phase 3
Development phase
89 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of this study is to examine the effect of LCIG relative to that of OMT on NMS associated with PD.

Primary Outcome

The NMSS consists of 30 questions in 9 domains (cardiovascular/falls, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, GI tract, urinary, sexual function, miscellaneous). Score of each question is calculated by multiplying severity\*frequency. Severity and frequency are rated using a scale ranging from 0 (none) to 3 (severe) for severity and from 1 (rarely) to 4 (very frequent) for frequency. Total score is the sum of 9 domains, and ranges from 0 to 360, with

Conditions Studied

Advanced Parkinson's Disease

Interventions

  • DRUG Optimized Medical Treatment
  • DRUG Levodopa-Carbidopa Intestinal Gel
  • DEVICE Nasojejunal (NJ) tube
  • DEVICE Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube

Study Locations (20)

Florida

  • Boca Raton Regional Hospital /ID# 200056 - Boca Raton
  • University of Florida Neurolog /ID# 168699 - Jacksonville
  • Parkinson's Disease Treatment Center of Southwest Florida /ID# 168085 - Port Charlotte

Other

  • Central Hospital Bremerhaven /ID# 136573 - Bremerhaven
  • Mediterraneo Hospital /ID# 208042 - Glyfada
  • Ospedale Bellaria.Azienda USL IRCCS.Istituto delle Scienze Neurologiche di Bolog /ID# 136789 - Bologna

Victoria

  • Royal Melbourne Hospital /ID# 136780 - Parkville
  • Goulburn Valley Hospital /ID# 164202 - Shepparton

Ontario

  • The Ottawa Hospital /ID# 139341 - Ottawa
  • Toronto Western Hospital /ID# 136585 - Toronto

California

  • Parkinson's and Movement /ID# 161596 - Fountain Valley

Illinois

  • Rush University Medical Center /ID# 168088 - Chicago

Missouri

  • St. Luke's Health System /ID# 168706 - Kansas City

Texas

  • Central Texas Neurology Consul /ID# 168087 - Round Rock

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2015-10-26
Est. Completion 2022-11-18
Phase Phase 3
AbbVie

526 total trials

What the finished NCT02549092 record still lists

NCT02549092 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 105-participant average among 3 other Advanced Parkinson's Disease trials with a reported enrollment target (15% lower).

The record links to 1 condition, with Advanced Parkinson's Disease appearing as the primary indexed condition, and to 4 interventions - of which Optimized Medical Treatment is the first listed.

NCT02549092 names 20 study sites across 14 states, led by Florida, Other, Victoria.

Frequently Asked Questions

What is clinical trial NCT02549092 about?

NCT02549092 is a clinical study titled "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)". The primary objective of this study is to examine the effect of LCIG relative to that of OMT on NMS associated with PD.

What is the current status of trial NCT02549092?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2015-10-26. Estimated completion is 2022-11-18.

What conditions does trial NCT02549092 study?

This clinical trial studies the following conditions: Advanced Parkinson's Disease.

What interventions are being tested in trial NCT02549092?

The interventions under investigation include: Optimized Medical Treatment (DRUG), Levodopa-Carbidopa Intestinal Gel (DRUG), Nasojejunal (NJ) tube (DEVICE), Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube (DEVICE).

Who is sponsoring clinical trial NCT02549092?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02549092 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Missouri, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Advanced Parkinson's Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03682289 · 89 participants · Phase 2

    Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Solid Tumors

  • NCT04787939 · 89 participants · NA

    Early Feeding After Oral Cavity Reconstruction

  • NCT05480449 · 89 participants · Phase 1

    Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)

  • NCT05604131 · 89 participants · Phase 2

    Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT02549092, the US trial registry maintained by the National Library of Medicine. NCT02549092 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.