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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01747655
First received: December 10, 2012
Last updated: May 2, 2014
Last verified: May 2014
  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
Parkinson's Disease

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Standard of care
Patients that return to oral or transdermal anti-parkinson's disease medications

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
Study Population

Hospital clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747655

Contacts
Contact: IMA Affiliate Research Desk ima_ar@abbvie.com
Contact: Elisabeth Speakman +44 1628408204

  Show 39 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Koray Onuk, MD AbbVie
  More 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 2, 2014
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:
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 July 24, 2014