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

NCT00660673 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: S187.3.0052008-001329-33
• Study Type: interventional
• Target: 262
• Locations: 11 countries
• Sites: 61

Brief Summary

The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment (Study S187.3.003 \[NCT00360568\] or Study S187.3.004 \[NCT00335153\]).

Conditions

Advanced Parkinson's Disease

Keywords

levodopa/carbidopa intestinal gel; Severe Motor Fluctuations; Levodopa; Carbidopa; Parkinson's Disease; Dyskinesia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events

  Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) which started on or after the date of the first LCIG Infusion in this study and within 30 days of the date of the last PEG-J exposure. At least possibly drug-related is defined as TEAEs assessed as having a "Possible" or "Probable" or missing relationship to study drug. Serious AEs included any untoward medical occurrence that: * Resulted in death * Was life-threatening * Required inpatient hospitalization or prolongation of an existing hospitalization * Resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect The severity of all AEs was characterized as mild, moderate or severe according to the following definitions: * Mild: usually transient and do not interfere with daily activities. * Moderate: low level of inconvenience or concern to the subject, may interfere with daily activities. * Severe: events interrupt the subject's usual daily activity.

  From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years).

Secondary Outcomes (21)

• Number of Participants With Device Complications

  From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days.

• Number of Participants With Sleep Attacks

  Baseline (final assessment period of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days.

• Number of Participants With Intense Impulsive Behavior

  Baseline (final assessment of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days.

• Number of Participants Who Developed Melanoma

  Once per year during the study; median duration of treatment was 1178 days.

• Number of Participants With Treatment-emergent Adverse Events of Special Interest (TE AESI)

  From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years).

Study Arms (1)

Levodopa-Carbidopa Intestinal Gel

EXPERIMENTAL

Initial dosing is based on the dosing regimen that the participant received during the previous LCIG study. Dosing is individually optimized and can be adjusted at any time during the study as clinically indicated. The total dose/day of LCIG is composed of 3 individually adjusted doses. The morning dose is administered as a bolus infusion, usually 5 to 10 mL (100 to 200 mg levodopa). The maintenance dose is adjustable in steps of 2 mg/hour (0.1 mL/hour), within a range of 1 to 10 mL/hour (20 to 200 mg levodopa/hour) and is usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour). Participants will be allowed to self-administer extra doses of LCIG to address immediate medical needs, normally 0.5 to 2.0 mL. Participants will receive LCIG until it is commercially available.

Drug: Levodopa-Carbidopa Intestinal Gel (LCIG); Device: CADD-Legacy® 1400 ambulatory infusion pump; Device: Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)

Interventions

Levodopa-Carbidopa Intestinal Gel (LCIG) DRUG

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.

Also known as: Carbidopa-Levodopa Enteral Suspension (CLES), Duopa®, Duodopa®

Levodopa-Carbidopa Intestinal Gel

CADD-Legacy® 1400 ambulatory infusion pump DEVICE

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

Levodopa-Carbidopa Intestinal Gel

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

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

Levodopa-Carbidopa Intestinal Gel

Eligibility Criteria

• Age: 30 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant should have completed participation in Study S187.3.003 or S187.3.004; and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG.
• For Canada, participants will be allowed to participate in the S187.3.005 study with a minimum of 6 months of exposure to LCIG in the S187.3.004 study.
• The participant must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study related procedures. If the participant does not have the capacity to provide informed consent, full informed consent must be obtained from the participant's legally authorized representative. Consenting will be performed according to local regulations.

You may not qualify if:

• Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be clinically significant and which could interfere with the participant's participation in the study.

Sponsors & Collaborators

• AbbVie: lead
• IQVIA, formerly Quintiles: collaborator

Study Sites (61)

University of Alabama at Birmingham /ID# 49941

Birmingham, Alabama, 35294, United States

Location

The Research Center of Southern California /ID# 49928

Encinitas, California, 92024, United States

Location

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

Fountain Valley, California, 92708, United States

Location

Universtiy of Southern California /ID# 49913

Los Angeles, California, 90033, United States

Location

Colorado Neurological Institute /ID# 49927

Englewood, Colorado, 80113, United States

Location

Georgetown University Hospital /ID# 49931

Washington D.C., District of Columbia, 20007, United States

Location

Bradenton Research Center, Inc /ID# 49929

Bradenton, Florida, 34205, United States

Location

Neurologic Consultants, PA /ID# 49918

Fort Lauderdale, Florida, 33308, United States

Location

University of Florida - Archer /ID# 49935

Gainesville, Florida, 32610, United States

Location

University of Florida /ID# 49922

Jacksonville, Florida, 32209, United States

Location

Charlotte Neurological Service /ID# 49916

Port Charlotte, Florida, 33980, United States

Location

University of South Florida /ID# 49919

Tampa, Florida, 33612, United States

Location

Georgia Regents University /ID# 49938

Augusta, Georgia, 30912, United States

Location

Northwestern University Feinberg School of Medicine /ID# 49944

Chicago, Illinois, 60611-2927, United States

Location

Rush University Medical Center /ID# 49930

Chicago, Illinois, 60612, United States

Location

University of Kentucky Chandler Medical Center /ID# 49940

Lexington, Kentucky, 40536, United States

Location

Louisiana State Univ HSC /ID# 49945

Shreveport, Louisiana, 71130, United States

Location

Univ Maryland School Medicine /ID# 49934

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University /ID# 49937

Baltimore, Maryland, 21287, United States

Location

Washington University-School of Medicine /ID# 49933

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center /ID# 49911

Omaha, Nebraska, 68198, United States

Location

North Shore University Hospital /ID# 49932

Manhasset, New York, 11030, United States

Location

The Mount Sinai Hospital /ID# 49942

New York, New York, 10029, United States

Location

Columbia Univ Medical Center /ID# 49943

New York, New York, 10032-3725, United States

Location

Raleigh Neurology Associates /ID# 49923

Raleigh, North Carolina, 27607, United States

Location

Wake Forest Univ HS /ID# 49939

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati /ID# 49914

Cincinnati, Ohio, 45267-0585, United States

Location

Cleveland Clinic Main Campus /ID# 76173

Cleveland, Ohio, 44195, United States

Location

University of Vermont Medical Center /ID# 49912

Burlington, Vermont, 05401-1473, United States

Location

King County Public Hospital /ID# 49917

Kirkland, Washington, 98034, United States

Location

Froedtert Memorial Lutheran Hospital /ID# 49924

Milwaukee, Wisconsin, 53226, United States

Location

Westmead Hospital /ID# 50081

Westmead, New South Wales, 2145, Australia

Location

Royal Adelaide Hospital /ID# 50083

Adelaide, South Australia, 5000, Australia

Location

Austin Hospital /ID# 50082

Heidelberg, Victoria, 3084, Australia

Location

University of Alberta /ID# 78476

Edmonton, Alberta, T6G 2B7, Canada

Location

Toronto Western Hospital /ID# 75913

Toronto, Ontario, M5T 2S8, Canada

Location

CHUM - Notre-Dame Hospital /ID# 74513

Montreal, Quebec, H2X 0A9, Canada

Location

Fakultni Nemocnice u Svate Anny /ID# 50085

Brno, 656 91, Czechia

Location

Fakultni nemocnice Hradec Kralove /ID# 50088

Hradec Králové, 500 05, Czechia

Location

Pardubicka krajska nemocnice, a.s.

Pardubice, 532 03, Czechia

Location

Vseobecna fakultni nemocnice v Praze /ID# 50086

Prague, 128 21, Czechia

Location

Fakultni Nemocnice v Motole /ID# 50084

Prague, 150 06, Czechia

Location

Tel Aviv Sourasky Medical Center /ID# 50089

Tel Aviv, 64239, Israel

Location

Waikato Hospital /ID# 50091

Hamilton, Waikato Region, 3240, New Zealand

Location

Auckland City Hospital /ID# 50093

Auckland, 1023, New Zealand

Location

New Zealand Brain Research Institute/ID# 50090

Christchurch, 8011, New Zealand

Location

Wellington Hospital /ID# 50092

Wellington, 6021, New Zealand

Location

NZOZ Centrum Medyczne HCP /ID# 50094

Poznan, Greater Poland Voivodeship, 61-485, Poland

Location

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

Lodz, Łódź Voivodeship, 93-113, Poland

Location

Hospitais da Universidade de Coimbra /ID# 50098

Coimbra, 3000-075, Portugal

Location

Hospital de Santa Maria /ID# 50099

Lisbon, 1649-035, Portugal

Location

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

Porto, 4200-319, Portugal

Location

Scientific Research Medical Complex Your Health /ID# 50104

Kazan', 420097, Russia

Location

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

Moscow, 125367, Russia

Location

Military Medical Academy n.a. Kirov /ID# 50103

Saint Petersburg, 194044, Russia

Location

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

Saint Petersburg, 197022, Russia

Location

City Clinical Hospital #40 /ID# 50106

Saint Petersburg, 197706, Russia

Location

King Chulalongkorn Mem Hosp /ID# 50108

Bangkok, 10330, Thailand

Location

Siriraj Hospital /ID# 50109

Bangkok, 10700, Thailand

Location

The Walton Centre NHS Foundation /ID# 50003

Liverpool, L9 7LJ, United Kingdom

Location

National Hospital for Neurology & Neurosurgery

London, WC1N 3BG, United Kingdom

Location

Related Publications (1)

• Fernandez HH, Boyd JT, Fung VSC, Lew MF, Rodriguez RL, Slevin JT, Standaert DG, Zadikoff C, Vanagunas AD, Chatamra K, Eaton S, Facheris MF, Hall C, Robieson WZ, Benesh J, Espay AJ. Long-term safety and efficacy of levodopa-carbidopa intestinal gel in advanced Parkinson's disease. Mov Disord. 2018 Jul;33(6):928-936. doi: 10.1002/mds.27338. Epub 2018 Mar 23.

  PMID: 29570853 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 17, 2008
• Study Start: November 13, 2009
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 2, 2022
• Results First Posted: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

CZ (5); CA (3); PL (2); AU (3); PT (3); RU (5); IL (1); NZ (4); TH (2); GB (2); US (31)