The primary objective of the study is to assess the effectiveness of LECIGON® treatment on the reduction in OFF time (h/day) from baseline at 12 months as measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale, Part IV (MDS-UPDRS IV).
Study Type
OBSERVATIONAL
Enrollment
215
This is a non-interventional study.
Complejo Hospitalario Universitario de A Coruña (CHUAC)
A Coruña, A Coruña, Spain
RECRUITINGVirgen del Rocío University Hospital
Seville, Av. Manuel Siurot, S/n, Spain
RECRUITINGHospital Universitario de Toledo
Toledo, Castille-La Mancha, Spain
Change from Baseline in the Reduction in OFF time (h/day) as Measured by Movement Disorder Society-unified Parkinson's Disease Rating Scale, Part IV (MDS-UPDRS IV) at 12 months
The MDS-UPDRS is a revision of the Unified Parkinson's disease rating scale (UPDRS) developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part IV concerns motor complication and all questions in Part IV that deal with motor fluctuations and dyskinesias, the investigator is required to conduct the interview of participants.
Time frame: Baseline, Month 12
Change from Baseline in the Reduction in OFF time (h/day) as Measured by MDS-UPDRS IV at 6 months
The MDS-UPDRS is a revision of the UPDRS developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part IV concerns motor complication and all questions in Part IV that deal with motor fluctuations and dyskinesias, the investigator is required to conduct the interview of participants.
Time frame: Baseline, Month 6
Change from Baseline in the Reduction in OFF time (h/day) as Measured by Hauser Patient Diaries
The Hauser Diary is a home diary, completed by the participant, that assesses functional status in participants with Parkinson's disease with motor fluctuations and dyskinesia. Participants will complete the Hauser Diary for a 72-hour period occurring after informed consent has been obtained and prior to LECIGON® treatment start and for 48 hours prior to each of the two follow-up visits.
Time frame: Baseline, Months 6 and 12
Change from Baseline in LECIGON® Treatment Patterns due to Change in Daily Levodopa Dose (mg/day) as Measured by Total Daily Dose Using Multi-rate Programming of Pump
Total daily levodopa dose will be measured using the multi-rate programming of pump.
Time frame: Baseline, Months 6 and 12
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Hospital de Cruces
Barakaldo, Vizcaya, Spain
RECRUITINGHospital de Basurto
Bilbao, Vizcaya, Spain
RECRUITINGChange from Baseline in Clinical Global Impression of Improvement as Measured by Clinical Global Impression of Change (CGI-C)
Time frame: Baseline, Months 6 and 12
Change from Baseline in Clinical Global Impression of Improvement as Measured by Patient Global Impression of Change (PGI-C) at 12 months
Time frame: Baseline, Months 6 and 12
Change from Baseline in Non-motor Experiences of Daily Living as Measured by MDS-UPDRS-I
The MDS-UPDRS is a revision of the UPDRS developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part I concerns non-motor experiences of daily living. Several questions from Part I are designed to be amenable to a patient/caregiver questionnaire format and therefore can be completed without the investigator's input. For the remaining Part I questions that deal with complex behaviors, the investigator is required to conduct the interview of participants.
Time frame: Baseline, Months 6 and 12
Change from Baseline in Motor Complications as Measured by MDS-UPDRS-IV
The MDS-UPDRS is a revision of the UPDRS developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part IV concerns motor complication and all questions in Part IV that deal with motor fluctuations and dyskinesias, the investigator is required to conduct the interview of participants.
Time frame: Baseline, Months 6 and 12
Change from Baseline in Quality of Life as Measured by Parkinson's Disease Questionnaire Total Score (PDQ-8)
The PDQ-8 is an eight-question instrument, completed by the participants, that measures the quality of life among Parkinson's disease participants. It is a shortened version of the 39-item Parkinson's disease questionnaire to reduce participant burden and increase convenience for use among Parkinson's disease participants. It includes one question from each of the dimensions including include mobility, activities of daily of living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort.
Time frame: Baseline, Months 6 and 12
Change from Baseline in Sleep as Measured by Parkinson's Disease Sleep Scale - 2 (PDSS-2)
The PDSS is a visual analogue scale, completed by the Parkinson's disease participant, addressing 15 commonly reported symptoms associated with sleep disturbances, including overall quality of night's sleep, sleep onset and maintenance insomnia, nocturnal restlessness, nocturnal psychosis, nocturia, nocturnal motor symptoms, sleep refreshment, and daytime dozing. The PDSS-2 uses a 5-point frequency scale (0-4) for each item, with a total score ranging from 0 to 60. Higher scores indicate more severe sleep problems.
Time frame: Baseline, Months 6 and 12
Treatment Satisfaction Questionnaire at Months 6 and 12
Participants will be asked questions to assess their satisfaction with LECIGON® treatment.
Time frame: At Months 6 and 12
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Months 6 and 12
Number of Participants With Adverse Drug Reactions (ADRs), Serious ADRs, Reportable Events (REs), Serious REs and REs of Special Interest (RESIs)
An ADR is any untoward and unintended response to a medicinal product, related to any dose administered and which implies a RE with at least a reasonable possibility of a causal relationship with the use of the product. A RE is any unfavorable or unintended sign, symptom or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. RESIs include drug interaction, drug exposure during pregnancy, drug exposure during breastfeeding, lack of drug efficacy, overdose, misuse/abuse, medication errors (incl. prescription and application errors), off-label use, adverse reaction which occurred during occupational exposure, falsified medicinal product, suspected transmission of infectious agents via a medicinal product.
Time frame: 12 months