Long-Term Observational Study on Effectiveness and Safety of Lecigon in Patients With Advanced Parkinson's Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Lecigon® based on European Medicines Agency (EMA) SmPC: There might be different brand names in other countries

Study summary

This observational study is designed to collect data on the use of the drug Lecigon® in daily clinical practice. The study is organised and funded by a pharmaceutical company called Britannia Pharmaceuticals Ltd (Britannia).

Lecigon® is prescribed by physicians in advanced Parkinson's disease when patients suffer from uncontrollable fluctuations in mobility, so-called motor fluctuations, which cannot be adjusted well with oral treatment, i.e. medication for swallowing.

In this study, data on the effect and possible side effects from everyday treatment with Lecigon® will be collected and scientifically evaluated. The study is intended to supplement the results of previous clinical studies with clinical data in routine medical care, collected from approximately 300 patients.

Eligibility

Primary outcome measure(s)

• Change in OFF time from baseline up to 24 months, or treatment or study discontinuation — 24 months
  To assess the effectiveness of Lecigon® treatment on the change in OFF time (h/day) from baseline up to 24 months, or treatment or study discontinuation as measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale IV Scores (MDS-UPDRS IV- motor complications)
• Change in activities of daily living from baseline up to 24 months, or treatment or study discontinuation — 24 months
  To assess the effectiveness of Lecigon® treatment on the change in motor experiences of daily living from baseline up to 24 months, or treatment or study discontinuation as measured by Movement Disorder Society-Unified Parkinson's Disease Rating Scale II Scores (MDS-UPDRS II - motor experiences of daily living)
• Change in Daily Levodopa dose from baseline up to 24 months, or treatment or study discontinuation — 24 months
  To assess the effectiveness of Lecigon® treatment on the change in Daily Levodopa dose \[mg/day\] from baseline up to 24 months, or treatment or study discontinuation as measured by morning bolus, continuous flow, extra boli, oral doses
• Usage of other Anti-Parkinsonian medicinal products from baseline up to 24 months, or treatment or study discontinuation — 24 months
  To assess the effectiveness of Lecigon® treatment as measured by usage of other anti-Parkinsonian medicinal products (e.g. levodopa, dopamine agonists, Monoamine Oxidase (MAO)-B inhibitors, amantadine from baseline up to 24 months, or treatment or study discontinuation
• Usage of the Lecigon® pump from baseline up to 24 months, or treatment or study discontinuation — 24 months
  To assess the effectiveness of Lecigon® treatment use of programmed pump rate (2 or 3 rates) from baseline up to 24 months, or treatment or study discontinuation will be collected
• Change in Clinical Global Impression of Improvement (CGI-I) from baseline up to 24 months, or treatment or study discontinuation — 24 months
  To assess the effectiveness of Lecigon® treatment on the change in Clinical Global Impression of Improvement (CGI-I) from baseline up to 24 months, or treatment or study discontinuation as measured by Clinical Global Impression of Improvement Scale Score (CGI-I)
• Change in Patient Global Impression of Change from baseline up to 24 months, or treatment or study discontinuation — 24 months
  To assess the effectiveness of Lecigon® treatment on the change in Patient Global Impression of Change (PGI-C) from baseline up to 24 months, or treatment or study discontinuation as measured by Patient Global Impression of Change Scale Score (PGI-C)
• Satisfaction with treatment from baseline up to 24 months or treatment or study discontinuation — 24 months
  To assess the effectiveness with Lecigon®, satisfaction with treatment will be assessed in terms of pump size, weight, noise, handling and overall pump satisfaction from baseline up to 24 months or treatment or study discontinuation as measured by device satisfaction scale score between 0 (absolutely unsatisfied) to 10 (absolutely satisfied) for each item.
• Occurrence of AEs and SAEs from baseline up to 24 months or treatment or study discontinuation — 24 months
  To assess the long-term safety of Lecigon® treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) (including drug-related, device- and procedure-related Adverse Drug Reactions (ADRs) and Serious Adverse Drug Reactions (SADRs), AEs of special interest) from time of Informed consent to study completion for up to 24 months or treatment or study discontinuation will be collected

Trial sites (57)

+ 17 more sites — see the full list on the official registry below.