Clinical trial NCT00660673: Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease
Official title: Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Parkinson's Disease
Keywords: levodopa/carbidopa intestinal gel
Severe Motor Fluctuations
Levodopa
Carbidopa
Parkinson's Disease
Dyskinesia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: IQVIA, formerly Quintiles
First posted: 2008-04-17
Enrollment: 262
Minimum age (years): 30
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 \[NCT00335153\]).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: 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:
measure: Number of Participants With Device Complications
timeFrame: 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.
measure: Number of Participants With Sleep Attacks
timeFrame: 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.
measure: Number of Participants With Intense Impulsive Behavior
timeFrame: Baseline (final assessment of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days.
measure: Number of Participants Who Developed Melanoma
timeFrame: Once per year during the study; median duration of treatment was 1178 days.
measure: Number of Participants With Treatment-emergent Adverse Events of Special Interest (TE AESI)
timeFrame: 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).
measure: Number of Participants With Any Suicidal Ideation or Behavior
timeFrame: Every 6 months (beginning with implementation of Protocol Amendment 3) until final visit; median duration of treatment was 1178 days.
measure: Number of Participants With Potentially Clinically Significant Vital Sign Values
timeFrame: Baseline and every 6 months until final visit; median duration of treatment was 1178 days.
measure: Number of Participants With Potentially Clinically Significant Hematology Laboratory Values
timeFrame: Baseline and every 6 months until final visit; median duration of treatment was 1178 days.
measure: Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values
timeFrame: Baseline and every 6 months until final visit; median duration of treatment was 1178 days.
measure: Number of Participants With Vitamin Levels Outside of the Normal Range
timeFrame: Every 6 months (beginning with implementation of Protocol Amendment 2) until final visit; median duration of treatment was 1178 days.
measure: Number of Participants Receiving Concomitant Anti-Parkinson's Disease Medications by Treatment Year
timeFrame: Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10, > Year 10 (maximum time on treatment was approximately 11.5 years).
measure: Change in Average Daily "Off" Time Based on the Parkinson's Disease Symptom Diary at End of Treatment
timeFrame: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
measure: Change in Average Daily "On" Time Without Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment
timeFrame: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
measure: Change in Average Daily "On" Time With Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment
timeFrame: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at End of Treatment
timeFrame: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at End of Treatment
timeFrame: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at End of Treatment
timeFrame: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at End of Treatment
timeFrame: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at End of Treatment
timeFrame: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Dyskinesia Score at End of Treatment
timeFrame: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
measure: Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment
timeFrame: Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham /ID# 49941
state: Alabama
city: Encinitas
country: United States
facility: The Research Center of Southern California /ID# 49928
state: California
city: Fountain Valley
country: United States
facility: The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 49915
state: California
city: Los Angeles
country: United States
facility: Universtiy of Southern California /ID# 49913
state: California
city: Englewood
country: United States
facility: Colorado Neurological Institute /ID# 49927
state: Colorado
city: Washington
country: United States
facility: Georgetown University Hospital /ID# 49931
state: District of Columbia
city: Bradenton
country: United States
facility: Bradenton Research Center, Inc /ID# 49929
state: Florida
city: Fort Lauderdale
country: United States
facility: Neurologic Consultants, PA /ID# 49918
state: Florida
city: Gainesville
country: United States
facility: University of Florida - Archer /ID# 49935
state: Florida
city: Jacksonville
country: United States
facility: University of Florida /ID# 49922
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Neurological Service /ID# 49916
state: Florida
city: Tampa
country: United States
facility: University of South Florida /ID# 49919
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University /ID# 49938
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 49944
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center /ID# 49930
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center /ID# 49940
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana State Univ HSC /ID# 49945
state: Louisiana
city: Baltimore
country: United States
facility: Univ Maryland School Medicine /ID# 49934
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University /ID# 49937
state: Maryland
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 49933
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center /ID# 49911
state: Nebraska
city: Manhasset
country: United States
facility: North Shore University Hospital /ID# 49932
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital /ID# 49942
state: New York
city: New York
country: United States
facility: Columbia Univ Medical Center /ID# 49943
state: New York
city: Raleigh
country: United States
facility: Raleigh Neurology Associates /ID# 49923
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Univ HS /ID# 49939
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 49914
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus /ID# 76173
state: Ohio
city: Burlington
country: United States
facility: University of Vermont Medical Center /ID# 49912
state: Vermont
city: Kirkland
country: United States
facility: King County Public Hospital /ID# 49917
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital /ID# 49924
state: Wisconsin
city: Westmead
country: Australia
facility: Westmead Hospital /ID# 50081
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 50083
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Hospital /ID# 50082
state: Victoria
city: Edmonton
country: Canada
facility: University of Alberta /ID# 78476
state: Alberta
city: Toronto
country: Canada
facility: Toronto Western Hospital /ID# 75913
state: Ontario
city: Montréal
country: Canada
facility: CHUM - Notre-Dame Hospital /ID# 74513
state: Quebec
city: Brno
country: Czechia
facility: Fakultni Nemocnice u Svate Anny /ID# 50085
city: Hradec Králové
country: Czechia
facility: Fakultni nemocnice Hradec Kralove /ID# 50088
city: Pardubice
country: Czechia
facility: Pardubicka krajska nemocnice, a.s.
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze /ID# 50086
city: Praha
country: Czechia
facility: Fakultni Nemocnice v Motole /ID# 50084
city: Tel-Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 50089
city: Hamilton
country: New Zealand
facility: Waikato Hospital /ID# 50091
state: Waikato
city: Auckland
country: New Zealand
facility: Auckland City Hospital /ID# 50093
city: Christchurch
country: New Zealand
facility: New Zealand Brain Research Institute/ID# 50090
city: Wellington
country: New Zealand
facility: Wellington Hospital /ID# 50092
city: Łódź
country: Poland
facility: Miejskie Centrum Medyczne im. dr. Karola Jonschera w Lodzi /ID# 50096
state: Lodzkie
city: Poznań
country: Poland
facility: NZOZ Centrum Medyczne HCP /ID# 50094
state: Wielkopolskie
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra /ID# 50098
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria /ID# 50099
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 50101
city: Kazan
country: Russian Federation
facility: Scientific Research Medical Complex Your Health /ID# 50104
city: Moscow
country: Russian Federation
facility: Institution of the Russian Academy of Medical Sciences Scientific Centre of Neurology /ID# 50102
city: Saint Petersburg
country: Russian Federation
facility: Military Medical Academy n.a. Kirov /ID# 50103
city: Saint Petersburg
country: Russian Federation
facility: I.P. Pavlov First St. Petersburg State Medical University /ID# 50107
city: Saint Petersburg
country: Russian Federation
facility: City Clinical Hospital #40 /ID# 50106
city: Bangkok
country: Thailand
facility: King Chulalongkorn Mem Hosp /ID# 50108
city: Bangkok
country: Thailand
facility: Siriraj Hospital /ID# 50109
city: Liverpool
country: United Kingdom
facility: The Walton Centre NHS Foundation /ID# 50003
city: London
country: United Kingdom
facility: National Hospital for Neurology & Neurosurgery
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: 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.