Non-motor symptoms in advanced Parkinson's disease MedDRA version: 19.0 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Duodopa
Pharmaceutical Form: Intestinal gel
INN or Proposed INN: Levodopa
CAS Number: 59-92-7
Other descriptive name: LEVODOPA
Concentration unit: mg/ml milligram(s)/millilitre
Concentrat
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must have a minimum PDSS-2 total score of 20 at Baseline assessment. 2. Subject must have a diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria. See Appendix C for UKPDS. 3. Subject demonstrates persistent motor fluctuations in spite of individually optimized treatment. 4. The subject's Parkinson's disease is levodopa-responsive. 5. Subject has had optimal treatment with available anti-PD medication and their motor symptoms are judged inadequately controlled on this optimized treatment. Optimized treatment is defined as the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected regardless of any additional manipulations of levodopa and/or other antiparkinsonian medication. This will be based on the Investigator's clinical judgment. 6. Subject and/or if applicable, their care-partner must be able to complete the Subject Dosing Diary and must be able to demonstrate the ability to operate, manipulate and care for the infusion pump and tubing. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: 1. Subject's PD diagnosis is unclear or there is a suspicion that the subject has a parkinsonian syndrome such as secondary parkinsonism (e.g., caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), parkinson-plus syndrome (e.g., Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body disease) or other neurodegenerative disease that might mimic the symptoms of PD. 2. Subject has undergone neurosurgery for the treatment of Parkinson's disease. 3. Subject has any neurological deficit that might interfere with the study assessments (e.g., hemiparesis). 4. Known hypersensitivity to levodopa, carbidopa or radiopaque material. 5. Subject has contraindications to levodopa, (e.g., narrow angle glaucoma, malignant melanoma). 6. Subject experiencing clinically significant sleep attacks or clinically significant impulsive behavior (e.g., pathological gambling, hypersexuality) at any point during the three months prior to the Screening evaluation) as judged by the Principal Investigator. 7.Subject has undergone apomorphine continuous infusion for the treatment of Parkinson's disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to examine the effect of LCIG relative to that of OMT on non motor symptoms associated with advanced Parkinson's disease.;Secondary Objective: To assess the effect of LCIG relative to that of OMT on the motor symptoms/motor complications, safety, tolerability and health-related outcome measures.;Primary end point(s): Non-Motor Symptoms Scale (NMSS) Total Score and the Modified Parkinson's Disease Sleep Scale (PDSS-2) Total Score.;Timepoint(s) of evaluation of this end point: Baseline, Week 6, Week 12, Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Motor symptoms/motor complications will be measured by •Unified Parkinson's Disease Rating Scale (UPDRS) Parts III and IV Safety and tolerability will be assessed by: • Adverse event monitoring • Neurological exams • Clinical laboratory evaluations • Electrocardiogram • Vital signs and weight • Columbia Suicide Severity Rating Scale (C-SSRS) • Minnesota Impulsive Disorders Interview (MIDI) ? Sleep Attacks Questionnaire (SAQ) Health Related Outcomes will be measured by: • Parkinson's Disease Questionaire-8 (PDQ-8) • Clinical Global Impression of Change (CGI-C) • UPDRS Parts I and II • Patient Global Impression of Change (PGIC) • Montreal Cognitive Assessment Test (MOCA) • PD Anxiety Index (PAS) • Geriatric Depression Scale (GDS-15) • King PD Pain Scale;Timepoint(s) of evaluation of this end point: UPDRS Parts III and IV:Screening, Baseline, Week6, Week 12, Week 26 Safety and Tolerability: every visit HEOR: Baseline, Week 6, Week 12, Week 26 | — |
Countries
Australia, Canada, European Union, Germany, Italy, Spain, Sweden
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed