Long-term Safety and Effectiveness of Levodopa-carbidopa Intestinal Gel Infusion

Parkinson Disease Clinical Trial

Official title: Long-term Safety and Effectiveness in Motor and Non-motor Symptoms of Levodopa-carbidopa Intestinal Gel Infusion in Advanced Parkinson's Disease Patients With Motor Fluctuations

Status Recruiting

Clinical Trial Summary

Levodopa-carbidopa intestinal gel (LCIG) infusion has demonstrated to improve motor fluctuations. The aim of this study is to assess the long-term safety and effectiveness of LCIG infusion in advanced Parkinson's disease (PD) patients with motor fluctuations and its effect in non-motor symptoms.

Clinical Trial Description

The following parameters were analyzed prior to LCIG treatment (at baseline), at months one, three, six and twelve, and every year afterwards over a 10-year period:

• Safety:

• Adverse Events (AEs) related to percutaneous endoscopic gastrostomy (PEG) procedures and gastrostomy, infusion device, and treatment. Actions taken to solve them, and reasons for treatment discontinuation and withdrawal.

• Effectiveness:

• Motor fluctuations: Off time in hours recorded in Parkinson's Disease Diary©.

• Dyskinesia and other motor clinical aspects: evaluated with the Unified Parkinson's Disease Rating Scale (UPDRS) part IV, UPDRS part II in On and Off, UPDRS part III in On and Off, Hoehn and Yahr (H&Y) stage in On and Off and Schwab and England (S&E) scale.

• Non-motor clinical aspects: cognitive function through Mini Mental State Examination (MMSE), and UPDRS part I, and relevant neuropsychiatric disorders.

The parameters analyzed in the three prospective substudies carried out in three subsets of this population, are described below:

Substudy 1 - Cognition and behavior assessment: Subgroup evaluated with a specific neuropsychological battery for assessment of cognition and behavior disorders prior to treatment (at baseline) and after 6 months of LCIG, by the same neuropsychologist at the same environmental conditions and in patients in phase On. The cognitive examination included: tests that assessed cognitive areas affected in PD according to the literature, psychometric tests with well-known parameters, tests that can be used in different types of populations (neurologic and psychiatric disorders, screening, etc.), tests suitable for a population with low educational and cultural level.

• Attentional function: Forward Digit Span test of Weschler Adult Intelligence Scale-Third Edition (WAIS III); Audio-verbal attentional capacity; and Stroop Color-Word test.

• Executive functions: Backward Digit Span of WAIS III; Audio-verbal working memory; Stroop-word and Stroop-color subtests; Response inhibition capacity; Controlled Oral Word-Association Test (FAS) of phonemic verbal fluency; Category Naming Test (Animals) of semantic verbal fluency.

• Visual-constructional visuospatial and visuoperceptual functions: Clock Drawing Test - (order and copy) -visual-constructional; Reading clocks - simple visuospatial ability; Luria test of overlapping figures - visual perceptive skills function.

• Memory and learning: Rey Auditory Verbal Learning Test (RAVLT) - Short and long term audio-verbal memory and recognition.

• Language: Boston Naming Test (BNT) - Title by visual comparison.

• Motor functions: Luria motor sequences - Voluntary motor control, Motor coordination.

• Mood: Beck depression inventory (BDI)

• Behavior: Neuropsychiatric Inventory (NPI) - Exploration of psychological and behavioral symptoms.

Substudy 2 - Quality of sleep: Subgroup evaluated with Epworth scale, fatigue scale, Pittsburg quality of sleep questionnaire, Beck Depression Inventory (BDI), and Hamilton anxiety scale, administered prior to treatment (at baseline) and 6 months after treatment. In addition, an overnight polysomnography (PSG) study was carried out at these timings.

Substudy 3 - Health status, QoL and caregiver burden: Subgroup evaluated for up to 12 months, with the Spanish version of the 39-items quality of life questionnaire in PD (PDQ-39, 0-156), health status questionnaires (EQ-5D, range 5-15; and EQ-VAS range 0-100), global clinical impression scale (CGI, range 1-7), and caregiver burden questionnaire or Zarit Burden index (ZBI, range 0-100). Assessments were done prior to treatment (at baseline), 1 week, 3 months, 6 months and 12 months after treatment. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT03602924
• Study type: Observational
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Oriol de Fabregues, MD, PhD
• Phone: 00 34 934894258
• Email: odfabregues@vhebron.net
• Status: Recruiting
• Start date: December 1, 2008
• Completion date: December 31, 2018