Clinical trial NCT00360568: Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects
Official title: Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyskinesias
Parkinson's Disease
Severe Motor Fluctuations
Keywords: carbidopa
severe motor fluctuations
intestinal gel
levodopa
efficacy
levodopa carbidopa intestinal gel
dyskinesia
Parkinson's Disease
Duodopa
levodopa-carbidopa
DUOPA
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2006-08-04
Enrollment: 62
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.

Detailed description: Study S187.3.003 (NCT00360568) is a Phase 3, 12-month, open-label, multicenter continuation treatment study of the safety, tolerability, and efficacy of levodopa-carbidopa intestinal gel (LCIG) in the treatment of participants with levodopa-responsive Parkinson's disease (PD) with persistent motor fluctuations despite optimized treatment with available PD medications. All participants received LCIG.

Only participants who completed 12 weeks of double-blind, double-dummy treatment in Study S187.3.001 or S187.3.002 (NCT00357994/ NCT00660387) qualified for enrollment in this 12-month continuation treatment study.

Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's disease (PD) according to United Kingdon Parkinson's Disease Society (UKPDS) Brain Bank Criteria
* Levodopa-responsive with severe motor fluctuations
* Completion of protocol S187.3.001 (NCT00357994) or S187.3.002 (NCT00660387) and continue to meet the inclusion criteria for the preceding study

Exclusion Criteria:

* Patients with medically relevant abnormal findings (labs, electrocardiogram \[ECG\], physical examination, adverse events, psychiatric, neurological or behavioral disorders, etc.) at end of the double-blind phase (Week 12) of Study S187.3.001 (NCT00357994) or Study S187.3.002 (NCT00660387)

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
timeFrame: From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J, plus 30 days.
measure: Number of Participants With Device Complications
timeFrame: 12 months
measure: Number of Participants With Potentially Clinically Significant Values for Hematology Parameters
timeFrame: 12 months
measure: Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters
timeFrame: 12 months
measure: Number of Participants With Potentially Clinically Significant Vital Sign Parameters
timeFrame: 12 months
measure: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters
timeFrame: 12 months
measure: Number of Participants With Sleep Attacks at Baseline and Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL)
timeFrame: Baseline, Post-baseline (up to Month 12)
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Number of Participants With Confirmed Cases of Melanoma
timeFrame: up to Month 12
measure: Number of Participants With Clinically Significant Neurological Examination Findings
timeFrame: up to 12 months
measure: Columbia-Suicide Severity Rating Scale (C-SSRS) Findings
timeFrame: up to 12 months
measure: Number of Participants Taking at Least 1 Concomitant Medication During the Study
timeFrame: 12 months
Secondary outcomes:
measure: Change From Baseline in Average Daily "Off" Time at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Average Daily "On" Time Without Troublesome Dyskinesia at Month 12
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint
timeFrame: Baseline, Endpoint (Month 12 or last post-baseline visit)
measure: Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint
timeFrame: Baseline, Endpoint (Month 12 months or last post-baseline visit)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 45869
state: Alabama
city: Fountain Valley
country: United States
facility: Site Reference ID/Investigator# 45834
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 45854
state: California
city: Oceanside
country: United States
facility: Site Reference ID/Investigator# 45856
state: California
city: Washington
country: United States
facility: Site Reference ID/Investigator# 45859
state: District of Columbia
city: Bradenton
country: United States
facility: Site Reference ID/Investigator# 45857
state: Florida
city: Gainesville
country: United States
facility: Site Reference ID/Investigator# 45863
state: Florida
city: Port Charlotte
country: United States
facility: Site Reference ID/Investigator# 45836
state: Florida
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 45874
state: Illinois
city: Lexington
country: United States
facility: Site Reference ID/Investigator# 45868
state: Kentucky
city: Baltimore
country: United States
facility: Site Reference ID/Investigator# 45862
state: Maryland
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 45861
state: Missouri
city: New York
country: United States
facility: Site Reference ID/Investigator# 45873
state: New York
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 45878
state: Ohio
city: Cleveland
country: United States
facility: Site Reference ID/Investigator# 45850
state: Ohio
city: Burlington
country: United States
facility: Site Reference ID/Investigator# 45887
state: Vermont
city: Bochum
country: Germany
facility: Site Reference ID/Investigator# 45828
city: Bremerhaven
country: Germany
facility: Site Reference ID/Investigator# 45829
city: Hanover
country: Germany
facility: Site Reference ID/Investigator# 45825
city: Tuebingen
country: Germany
facility: Site Reference ID/Investigator# 54402
city: Auckland
country: New Zealand
facility: Site Reference ID/Investigator# 45884
city: Hamilton
country: New Zealand
facility: Site Reference ID/Investigator# 45885
Study officials:
affiliation: AbbVie
name: Janet Benesh
role: STUDY_DIRECTOR
References: