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
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Purpose
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.
| Condition |
|---|
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Parkinson's Disease |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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 |
- 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 ]
| Estimated Enrollment: | 60 |
| 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) |
| Groups/Cohorts |
|---|
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Duodopa
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
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Standard of care
Patients that return to oral or transdermal anti-parkinson's disease medications
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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/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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Hospital clinic
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
Contacts and Locations| Contact: IMA Affiliate Research Desk | ima_ar@abbvie.com | |
| Contact: Elisabeth Speakman | +44 1628644439 |
| Austria | |
| Site Reference ID/Investigator# 88055 | Recruiting |
| Graz, Austria, 8036 | |
| Principal Investigator: Site Reference ID/Investigator# 88055 | |
| Germany | |
| Site Reference ID/Investigator# 96636 | Recruiting |
| Kaiserslautern, Germany, 67655 | |
| Principal Investigator: Site Reference ID/Investigator# 96636 | |
| Greece | |
| Site Reference ID/Investigator# 89574 | Recruiting |
| Athens, Greece, 11525 | |
| Principal Investigator: Site Reference ID/Investigator# 89574 | |
| Netherlands | |
| Site Reference ID/Investigator# 93773 | Recruiting |
| Zwolle, Netherlands, 8011 JW | |
| Principal Investigator: Site Reference ID/Investigator# 93773 | |
| Study Director: | Sabine Neumann, MD | AbbVie |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01747655 History of Changes |
| Other Study ID Numbers: | P13-893 |
| Study First Received: | December 10, 2012 |
| Last Updated: | May 10, 2013 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios Italy: The Italian Medicines Agency Austria: Agency for Health and Food Safety Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by AbbVie:
|
Parkinson's Disease Early Observational Advanced |
Additional relevant MeSH terms:
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Carbidopa, levodopa drug combination Antiparkinson Agents Anti-Dyskinesia Agents |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adjuvants, Immunologic Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013