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)

PHASE3CompletedINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

October 26, 2015

Primary Completion Date

May 14, 2020

Study Completion Date

November 18, 2022

Conditions
Advanced Parkinson's Disease
Interventions
DRUG

Optimized Medical Treatment

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.

DRUG

Levodopa-Carbidopa Intestinal Gel

DEVICE

Nasojejunal (NJ) tube

optional prior to PEG-J placement

DEVICE

Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube

Trial Locations (38)

2145

Westmead Hospital /ID# 136575, Westmead

3050

Royal Melbourne Hospital /ID# 136780, Parkville

3630

Goulburn Valley Hospital /ID# 164202, Shepparton

5000

Royal Adelaide Hospital /ID# 136577, Adelaide

11009

Hospital Puerta del Mar /ID# 157977, Cadiz

11525

251 Airforce General Hospital /ID# 160594, Athens

13875

Azienda Sanitaria Locale di /ID# 160608, Ponderano,biella

16675

Mediterraneo Hospital /ID# 208042, Glyfada

17176

Karolinska Univ Sjukhuset /ID# 135961, Solna

18014

Hospital Universitario Virgen de las Nieves /ID# 136583, Granada

27574

Central Hospital Bremerhaven /ID# 136573, Bremerhaven

28034

Hospital Universitario Ramon y Cajal /ID# 136784, Madrid

32209

University of Florida Neurolog /ID# 168699, Jacksonville

33486

Boca Raton Regional Hospital /ID# 200056, Boca Raton

33980

Parkinson's Disease Treatment Center of Southwest Florida /ID# 168085, Port Charlotte

35016

CHU Insular-Materno Infantil /ID# 136783, Las Palmas de Gran Canaria

40139

Ospedale Bellaria.Azienda USL IRCCS.Istituto delle Scienze Neurologiche di Bolog /ID# 136789, Bologna

41013

Hospital Universitario Virgen del Rocio /ID# 145624, Seville

46026

Hospital Universitario y Politecnico La Fe /ID# 136722, Valencia

60126

A.O. Univ. Ospedali Riuniti /ID# 135964, Ancona

60612

Rush University Medical Center /ID# 168088, Chicago

64111

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

71100

A.O.U. Ospedali Riuniti di Fog /ID# 136792, Foggia

78681

Central Texas Neurology Consul /ID# 168087, Round Rock

92708

Parkinson's and Movement /ID# 161596, Fountain Valley

98125

A.O.U. Policlinico G. Martino /ID# 136790, Messina

99202-1342

Inland Northwest Research /ID# 200113, Spokane

T6G 2X8

University of Alberta /ID# 136586, Edmonton

K1H 8L6

The Ottawa Hospital /ID# 139341, Ottawa

M5T 2S8

Toronto Western Hospital /ID# 136585, Toronto

06132

Ospedale S.Maria della Miseri /ID# 160609, Perugia

00161

Azienda Policlinico Umberto I /ID# 201223, Roma

03722

Severance Hospital /ID# 163019, Seoul

03080

Seoul National University Hospital /ID# 162990, Seoul

05505

Asan Medical Center /ID# 163018, Seoul

08907

Hospital Universitario de Bellvitge /ID# 136579, L'Hospitalet de Llobregat

08036

Hospital Clinic de Barcelona /ID# 137689, Barcelona

08041

Hospital Santa Creu i Sant Pau /ID# 136581, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY