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)
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 patients 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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Analysis of MOtor and NOn Motor Symptoms, Quality of Life and Occurence of Dyskinesias in Advanced Parkinson's Disease Patients With 2 to 4 Hours 'Off-time' and Without Troublesome Dyskinesias Under Duodopa TREATment - a Multi-country Post-marketing Observational Study -MONOTREAT|
- Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
- Proportion of patients who continue with PEG-J treatment [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- UPDRS III, IV (items 32, 33, 34, 39) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
- Non-Motor Symptoms Scale [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
- Parkinson's Disease Quality of Life Questionnaire [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
- Healthcare Resource Utilization [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Patients given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy
Standard of care
Patients that return to oral or transdermal anti-parkinson's disease medications
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/ICF); 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 patients have a temporary naso-duodenal tube used initially with the infusion pump to determine if the subject responds favorably to this method of treatment and to optimize the dose of Duodopa before permanent treatment is started.
Patients who choose a treatment other than Duodopa after the temporary naso-duodenal test phase are considered for the Standard of Care group. Patients 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.
Patients who continue to with Duodopa treatment after the the temporary naso-duodenal test phase are the Duodopa group.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747655
|Contact: IMA Affiliate Research Deskfirstname.lastname@example.org|
|Contact: Elisabeth Speakman||+44 1628408204|
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|Study Director:||Koray Onuk, MD||AbbVie|