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

NCT01747655 | Completed Results

• 1 other identifier: P13-893
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease

Keywords

Early Observational Advanced; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 12 Months After Hospital Discharge

  The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during "On" time (when PD symptoms are well controlled by the drug) are presented. Last observation carried forward (LOCF) was used for missing data.

  Baseline (Week 0) and 12 months after hospital discharge

Secondary Outcomes (15)

• 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

  Baseline (Week 0) and 3, 6, and 12 months after hospital discharge

• Percentage of Participants Who Continued With Jejunal Extension Tube of the Percutaneous Endoscopic Gastrostomy (PEG-J) Treatment

  14 days

• Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study

  12 months

• 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

  Baseline (Week 0) and 3, 6, and 12 months after hospital discharge

• 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

  Baseline (Week 0) and 3, 6, and 12 months after hospital discharge

Study Arms (2)

Duodopa

Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)

Standard of Care

Participants that return to oral or transdermal anti-parkinson's disease medications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospital clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Links

• Related Info

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

Results for the SoC group should be interpreted with care due to the small number of patients. Also, when comparing the SoC and Duodopa groups one should be aware that patients of the SoC group may have had Duodopa treatment before returning to SoC.

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie

1-800-633-9110

Study Officials

• Koray Onuk, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 12, 2012
• Study Start: February 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 13, 2016
• Results First Posted: October 13, 2016

Record last verified: 2016-10