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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00335153
• Date of registration: 08/06/2006
• Prospective Registration: Yes
• Primary sponsor: AbbVie (prior sponsor, Abbott)
• Public title: Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease
• Scientific title: An Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor Fluctuations Despite Optimized Treatment With Available Parkinson's Disease Medications
• Date of first enrolment: January 2008
• Target sample size: 354
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00335153
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Canada, Czech Republic, Finland, Germany, Greece, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Russian Federation, Spain, Thailand, United Kingdom, United States

Contacts

• Name: Janet Benesh
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

- Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease
Society (UKPDS) Brain Bank Criteria

- Levodopa-responsive with severe motor fluctuations

- Recognizable off and on state (motor fluctuations) confirmed by diary

Exclusion Criteria:

- Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as
secondary parkinsonism

- Undergone surgery for the treatment of PD

- Contraindications to levodopa (such as narrow angle glaucoma)



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Advanced Parkinson's Disease

Intervention(s)

Device: CADD-Legacy® 1400 ambulatory infusion pump

Drug: Levodopa-carbidopa intestinal gel

Device: J-tube

Device: PEG tube

Primary Outcome(s)

Number of Participants With Potentially Clinically Significant Values for Hematology Parameters [Time Frame: Screening through Day 378]

Number of Participants With Sleep Attacks at Baseline [Time Frame: Baseline]

Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period [Time Frame: Baseline, during the Post-PEG Long-term Treatment Period (Day 28 through Day 378)]

Number of Participants With Device Complications During the Nasojejunal (NJ) Test Period [Time Frame: NJ Test Period (from 2 to 14 days)]

Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters [Time Frame: Screening through Day 378]

Number of Participants With Potentially Clinically Significant Vital Sign Parameters [Time Frame: up to 56 weeks]

Number of Participants Taking at Least 1 Concomitant Medication During the Study [Time Frame: Screening up to Day 378]

Number of Participants With Confirmed Cases of Melanoma [Time Frame: Screening up to Day 378]

Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period [Time Frame: During the Post-PEG Long-Term Treatment Period (Day 28 through Day 378)]

Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters [Time Frame: Screening through Day 378]

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint [Time Frame: Baseline, Endpoint (last Post-PEG Long-Term Period visit up to Day 378)]

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs [Time Frame: Screening through Day 378 + 30 days]

Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy - With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods [Time Frame: PEG-J Surgery Period (from 2 to 14 days) through the Long Term Treatment Period (Day 28 to Day 378)]

Secondary Outcome(s)

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Average Daily "Off" Time at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Average Daily "On" Time Without Troublesome Dyskinesia at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Month 12 [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint [Time Frame: Baseline, Endpoint (last post-baseline visit up to Day 378)]

Secondary ID(s)

S187.3.004

2006-005186-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Quintiles, Inc.

Results

• Results available: Yes
• Date Posted: 16/01/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00335153