Trials / Completed
CompletedNCT02381444
Health Related Quality of Life in LCIG Patients and LCIG Eligible Patients Continuing Oral Therapy
Health Related Quality of Life in LCIG Patients and LCIG Patients and LCIG Eligible Patients Continuing Oral Therapy. A Multicenter Post Marketing Observational Study for LCIG in Germany and Switzerland - BALANCE
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 136 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to assess the effect of LCIG (levodopa-carbidopa intestinal gel) on HRQL (Health-Related Quality of Life) of participants and compare the Health-Related Quality of Life between participants continuing to levodopa-carbidopa intestinal gel treatments versus participants continuing on oral therapy for Parkinson's Disease.
Detailed description
Parkinson's disease (PD) is the second most common neurodegenerative disorder in the world. It can be treated sufficiently until motor complications with fluctuations of mobility and dyskinesia develop. The quality of life is relentlessly deteriorating with longer disease duration once the complications of conservative oral therapy develop. Continuous dopaminergic stimulation using Levodopa/Carbidopa Intestinal Gel (LCIG) improves the motor complications of Parkinson's disease and preliminary data suggest that also the quality of life is improved. Primary Objective is to assess the effect of LCIG on Health Related Quality of Life (HRQL) of patients according to selection criteria from German guidelines and compare improvement in HRQL between patients continuing to LCIG treatment and patients staying on oral treatment, despite being eligible according to these guidelines. In addition, current selection criteria recommended by the national guideline will be documented at baseline.
Conditions
Timeline
- Start date
- 2015-04-17
- Primary completion
- 2020-01-07
- Completion
- 2020-01-07
- First posted
- 2015-03-06
- Last updated
- 2020-12-09
Locations
27 sites across 2 countries: Germany, Switzerland
Source: ClinicalTrials.gov record NCT02381444. Inclusion in this directory is not an endorsement.