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)

AbbVie

Status: Completed

Conditions: Parkinson's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01747655

P13-893

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

64 participants in 2 patient groups

Duodopa

Description:

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

Description:

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