Clinical trial NCT01747655: 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
Official title: 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 - MONOTREAT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Early Observational Advanced
Parkinson's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-12-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital clinic

Brief 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.

Detailed description: Data are recorded from visits most closely aligned with the planned periods of Visit 0 (V0): Baseline (After decision to use the temporary naso-duodenal tube (approximately 2-14 days) and after signature of the Patient Authorization/Informed Consent Form); Visit 1 (V1): At discharge from hospital; Visit 2 (V2): 3 months after discharge; Visit 3 (V3): 6 months after discharge; Visit 4 (V4): 12 months after discharge.

All participants have a temporary naso-duodenal tube used initially with the infusion pump to determine if the participant responds favorably to this method of treatment and to optimize the dose of Duodopa before permanent treatment is started.

Participants who choose a treatment other than Duodopa after the temporary naso-duodenal test phase are considered for the Standard of Care group. Participants who go on to select Apomorphine pump or Deep Brain Stimulation at any stage are not eligible to continue in this group or to continue in the observational period of study.

Participants who continue to with Duodopa treatment after the the temporary naso-duodenal test phase are the Duodopa group.

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

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 12 Months After Hospital Discharge
timeFrame: Baseline (Week 0) and 12 months after hospital discharge
Secondary outcomes:
measure: 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
timeFrame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
measure: Percentage of Participants Who Continued With Jejunal Extension Tube of the Percutaneous Endoscopic Gastrostomy (PEG-J) Treatment
timeFrame: 14 days
measure: Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study
timeFrame: 12 months
measure: 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
timeFrame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
measure: 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
timeFrame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
measure: 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
timeFrame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
measure: 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
timeFrame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
measure: Unified Parkinson's Disease Rating Scale (UPDRS) III (Motor Examination) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
timeFrame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
measure: 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
timeFrame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
measure: 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
timeFrame: Baseline (Week 0), at discharge from hospital, and 3, 6, and 12 months after hospital discharge
measure: Healthcare Resource Utilization (HCRU) Number of Office Visits: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
timeFrame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
measure: Healthcare Resource Utilization (HCRU) Number of Visits at Home: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge
timeFrame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
measure: Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge
timeFrame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
measure: 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
timeFrame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
measure: Healthcare Resource Utilization (HCRU) Falls: Percentage of Participants With Falls at 3, 6, and 12 Months After Hospital Discharge
timeFrame: Baseline (Week 0) and 3, 6, and 12 months after hospital discharge
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Koray Onuk, MD
role: STUDY_DIRECTOR
References: