Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

262

Participants

Timeline

Start Date

November 13, 2009

Primary Completion Date

November 30, 2021

Study Completion Date

November 30, 2021

Conditions
Advanced Parkinson's Disease
Interventions
DRUG

Levodopa-Carbidopa Intestinal Gel (LCIG)

LCIG for upper-intestinal infusion is a suspension of levodopa (20 mg/mL) and carbidopa (5 mg/mL) in an aqueous gel that is dispensed in a medication cassette reservoir containing 100 mL of LCIG.

DEVICE

CADD-Legacy® 1400 ambulatory infusion pump

Portable infusion pump (CADD-Legacy Pump Model 1400) connected to the LCIG medication cassette reservoir.

DEVICE

Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)

All participants previously had a PEG-J placed in one of the prior LCIG studies.

Trial Locations (61)

1023

Auckland City Hospital /ID# 50093, Auckland

2145

Westmead Hospital /ID# 50081, Westmead

3084

Austin Hospital /ID# 50082, Heidelberg

3240

Waikato Hospital /ID# 50091, Hamilton

5000

Royal Adelaide Hospital /ID# 50083, Adelaide

6021

Wellington Hospital /ID# 50092, Wellington

8011

New Zealand Brain Research Institute/ID# 50090, Christchurch

10029

The Mount Sinai Hospital /ID# 49942, New York

10330

King Chulalongkorn Mem Hosp /ID# 50108, Bangkok

10700

Siriraj Hospital /ID# 50109, Bangkok

11030

North Shore University Hospital /ID# 49932, Manhasset

20007

Georgetown University Hospital /ID# 49931, Washington D.C.

21201

Univ Maryland School Medicine /ID# 49934, Baltimore

21287

Johns Hopkins University /ID# 49937, Baltimore

27157

Wake Forest Univ HS /ID# 49939, Winston-Salem

27607

Raleigh Neurology Associates /ID# 49923, Raleigh

30912

Georgia Regents University /ID# 49938, Augusta

32209

University of Florida /ID# 49922, Jacksonville

32610

University of Florida - Archer /ID# 49935, Gainesville

33308

Neurologic Consultants, PA /ID# 49918, Fort Lauderdale

33612

University of South Florida /ID# 49919, Tampa

33980

Charlotte Neurological Service /ID# 49916, Port Charlotte

34205

Bradenton Research Center, Inc /ID# 49929, Bradenton

35294

University of Alabama at Birmingham /ID# 49941, Birmingham

40536

University of Kentucky Chandler Medical Center /ID# 49940, Lexington

44195

Cleveland Clinic Main Campus /ID# 76173, Cleveland

53226

Froedtert Memorial Lutheran Hospital /ID# 49924, Milwaukee

60612

Rush University Medical Center /ID# 49930, Chicago

63110

Washington University-School of Medicine /ID# 49933, St Louis

64239

Tel Aviv Sourasky Medical Center /ID# 50089, Tel Aviv

68198

University of Nebraska Medical Center /ID# 49911, Omaha

71130

Louisiana State Univ HSC /ID# 49945, Shreveport

80113

Colorado Neurological Institute /ID# 49927, Englewood

90033

Universtiy of Southern California /ID# 49913, Los Angeles

92024

The Research Center of Southern California /ID# 49928, Encinitas

92708

The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 49915, Fountain Valley

98034

King County Public Hospital /ID# 49917, Kirkland

125367

Institution of the Russian Academy of Medical Sciences Scientific Centre of Neurology /ID# 50102, Moscow

194044

Military Medical Academy n.a. Kirov /ID# 50103, Saint Petersburg

197022

I.P. Pavlov First St. Petersburg State Medical University /ID# 50107, Saint Petersburg

197706

City Clinical Hospital #40 /ID# 50106, Saint Petersburg

420097

Scientific Research Medical Complex Your Health /ID# 50104, Kazan'

60611-2927

Northwestern University Feinberg School of Medicine /ID# 49944, Chicago

10032-3725

Columbia Univ Medical Center /ID# 49943, New York

45267-0585

University of Cincinnati /ID# 49914, Cincinnati

05401-1473

University of Vermont Medical Center /ID# 49912, Burlington

T6G 2B7

University of Alberta /ID# 78476, Edmonton

M5T 2S8

Toronto Western Hospital /ID# 75913, Toronto

H2X 0A9

CHUM - Notre-Dame Hospital /ID# 74513, Montreal

656 91

Fakultni Nemocnice u Svate Anny /ID# 50085, Brno

500 05

Fakultni nemocnice Hradec Kralove /ID# 50088, Hradec Králové

532 03

Pardubicka krajska nemocnice, a.s., Pardubice

128 21

Vseobecna fakultni nemocnice v Praze /ID# 50086, Prague

150 06

Fakultni Nemocnice v Motole /ID# 50084, Prague

61-485

NZOZ Centrum Medyczne HCP /ID# 50094, Poznan

93-113

Miejskie Centrum Medyczne im. dr. Karola Jonschera w Lodzi /ID# 50096, Lodz

3000-075

Hospitais da Universidade de Coimbra /ID# 50098, Coimbra

1649-035

Hospital de Santa Maria /ID# 50099, Lisbon

4200-319

Centro Hospitalar Universitario de Sao Joao, EPE /ID# 50101, Porto

L9 7LJ

The Walton Centre NHS Foundation /ID# 50003, Liverpool

WC1N 3BG

National Hospital for Neurology & Neurosurgery, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

IQVIA, formerly Quintiles

UNKNOWN

lead

AbbVie

INDUSTRY