N/A N=64

A Post Marketing Observational Study of Activities of Daily Living in Advanced Parkinson's Disease Patients With Early Troublesome Motor Fluctuations and Treated With Duodopa - a Multi-country Study

Parkinson's Disease

Bottom Line

View on ClinicalTrials.gov: NCT01747655 ↗

Enrolled (actual)

Serious AEs

21.9%

Results posted

Oct 2016

Primary outcome: Primary: Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 12 Months After Hospital Discharge — -2.1; 1.4 units on a scale

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AbbVie (prior sponsor, Abbott)
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 12 Months After Hospital Discharge	-2.1; 1.4	—
SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge	-4.4; 0.9; -3.4; -1.5; -1.8; 0.5	—
SECONDARY Percentage of Participants Who Continued With Jejunal Extension Tube of the Percutaneous Endoscopic Gastrostomy (PEG-J) Treatment	90.6	—
SECONDARY Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study	9; 8; 2; 1; 1; 1	—
SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 32 (Duration) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge	-0.5; -0.5; -0.6; -0.5; -0.4; -0.2	—
SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 33 (Disability) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge	-0.9; -0.3; -0.9; -0.3; -0.5; -0.5	—
SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 34 (Pain) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge	-0.3; 0.2; -0.3; -0.3; -0.3; 0.3	—
SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Clinical Fluctuations) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge	-0.9; -0.5; -0.9; -0.7; -0.8; -0.3	—
SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) III (Motor Examination) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge	-12.9; -6.3; -8.9; -17.0; -8.7; 0.3	—
SECONDARY Non-Motor Symptoms Assessment Scale for Parkinson's Disease (NMSS Rating Scale) Total Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge	-39.5; -8.0; -33.7; -45.0; -33.9; -10.3	—
SECONDARY Parkinson's Disease Quality of Life Questionnaire (PDQ-8) Summary Index Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge	-15.7; -2.6; -15.4; -10.9; -12.3; -3.6	—
SECONDARY Healthcare Resource Utilization (HCRU) Number of Office Visits: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge	8.7; -3.0; -2.7; -2.1	—
SECONDARY Healthcare Resource Utilization (HCRU) Number of Visits at Home: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge	11.2; 0.8; -1.0; 4.0	—
SECONDARY Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge	14.1; 9.4; 10.2; 6.4; 10.9; 3.8	—
SECONDARY Healthcare Resource Utilization (HCRU) Received Assistance at Home: Percentage of Participants Who Received Assistance at Home at 3, 6, and 12 Months After Hospital Discharge	59.4; 49.1; 44.9; 46.8; 10.9; 24.5	—
SECONDARY Healthcare Resource Utilization (HCRU) Falls: Percentage of Participants With Falls at 3, 6, and 12 Months After Hospital Discharge	35.9; 17.0; 24.5; 14.9	—

Summary

Patients with advanced Parkinson's Disease experience a range in the severity of their motor fluctuations. The rationale for this Post Marketing Observational Study is to demonstrate the benefits of Duodopa treatment on Parkinson's Disease patients entering the advanced stage of the disease whose motor fluctuations have become troublesome and complicate management with oral therapy. The aim of this post-marketing observational study is to assess the effect of Duodopa treatment on activities of daily living in advanced Parkinson's Disease participants characterised by either 2-4 hours of "off" time or 2 hours of non-troublesome or troublesome dyskinesia daily, supported by a Unified Parkinson's Disease Rating Scale Total Score in the best "on" state of at least 40 points at baseline.

Eligibility Criteria

Inclusion Criteria

Has advanced levodopa-responsive Parkinson's disease
The decision to treat with Duodopa is made by the physician in accordance with the local label (Summary of Product Characteristics; product label) prior to any decision to approach the patient to participate in this study
Parkinson's Disease (PD) medicinal treatment is unchanged for at least four weeks prior to baseline
Takes oral medication four or more times daily
Either has 2-4 hours of "off" time or 2 hours of non-troublesome or troublesome dyskinesia daily supported by a Unified Parkinson's Disease Rating Scale (UPDRS) Total Score in the best "on" state of at least 40 points at baseline; based on documented medical history

Exclusion Criteria

Use of Deep Brain Stimulation (DBS), Apomorphine pump or Duodopa treatment prior to baseline visit
Severe dementia based on a Mini-Mental State Examination (MMSE) of < 24

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01747655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.