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Trial record 1 of 1 for:    Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease (DUOGLOBE)
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Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease (DUOGLOBE)

This study is currently recruiting participants.
Verified November 2017 by AbbVie
Sponsor:
ClinicalTrials.gov Identifier:
NCT02611713
First Posted: November 23, 2015
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
  Purpose
This study is a non-interventional post-marketing observational study (PMOS) of participants with advanced Parkinson's disease (PD) treated with Duodopa/Duopa in a routine clinical setting. Effectiveness of treatment will be collected with physician and participant/caregiver health outcomes beginning with PMOS enrollment (baseline visit), at the start of Duodopa/Duopa treatment via percutaneous endoscopic gastrostomy-with jejunal extension (PEG-J), at regularly scheduled visits closest to Months 3 and 6, and every 6 months thereafter up to 36 months.

Condition
Advanced Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: DUOdopa/Duopa in Patients With Advanced Parkinson's Disease (PD) - a GLobal Observational Study Evaluating Long-Term Effectiveness (DUOGLOBE)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change in the number of hours spent in OFF time [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment on OFF time measured by the change (from baseline to 36 months) in the number of hours spent in OFF time as reported by the participant for the day prior to the clinical visit.


Secondary Outcome Measures:
  • Change in the Duration of Dyskinesia [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in duration of dyskinesia as reported by the patient for the day prior to the clinical visit

  • Change in Activities of Daily Living [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in Activities of Daily Living as measured by Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activity of Daily Living) with a total score range of 0 to 52.

  • Change in Motor Function [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in motor function as measured by UPDRS, Part III (Motor Examination) with a total score range of 0 to 108.

  • Change in Tremor Severity [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in tremor severity as measured by UPDRS Part III, item 20 (Tremor at Rest) with a total score range of 0 to 20.

  • Change in Complications of Therapy [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in Complications of Therapy (dyskinesia duration, disability, pain and early morning dystonia) as measured by UPDRS Part IV (Complications of Therapy), items 32 (individual score 0 to 4), 33 (individual score 0 to 4), 34 (individual score 0 to 4), 35 (individual score 0 to 1) and total score range of 0 to 13.

  • Change in OFF Time Duration [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in OFF time duration as measured by UPDRS Part IV (Motor Fluctuations), item 39, with a total score range of 0 to 4.

  • Change in Dyskinesia Severity [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in dyskinesia severity as measured by Unified Dyskinesia Rating Scale (UDysRS) with a total score range from 0 to 104.

  • Change in Non-Motor Symptoms [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in non-motor symptoms as measured by Non-Motor Symptoms Scale (NMSS) with a total score range from 0 to 360.

  • Change in Disease-Specific Quality of Life [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in disease-specific quality of life (QoL) as measured by Parkinson's Disease Questionnaire 8 (PDQ-8) summary index range from 0 to 100.

  • Change in Generic Quality of Life [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in generic quality of life as measured by EuroQoL-5 Dimensions Quality of Life Questionnaire (EQ-5D) including EQ-Visual Analogue Scale (EQ-VAS). This assessment contains a health state descriptive part with five items scored from 1 to 3, a question about change in health state in the preceding 12 months and a VAS to evaluate current health state scored from 0 to 100.

  • Change in Overall Clinical Impression of Disease Severity [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in overall clinical impression of disease severity as measured by Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD) obtained by adding four domain scores with a total score range from 0 to 24.

  • Change in Disease-Specific Sleep Quality [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in disease-specific sleep quality as measured by Parkinson's Disease Sleep Scale-2 (PDSS-2) with a total score range from 0 to 60.

  • Change in Daytime Sleepiness [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in daytime sleepiness as measured by Epworth Sleepiness Scale (ESS) with a total score range from 0 to 24.

  • Change in Disease-Specific Caregiver Burden [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in disease-specific caregiver burden as measured by the Modified Caregiver Strain Index (MCSI) for PD with a total score range from 0 to 26.

  • Change in Healthcare Resource Utilization [ Time Frame: Baseline visit (Enrollment) to month 36 ]
    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in healthcare resource utilization as measured by the Healthcare Resource Utilization Questionnaire (HCRU).


Estimated Enrollment: 200
Study Start Date: January 4, 2016
Estimated Study Completion Date: March 27, 2021
Estimated Primary Completion Date: March 27, 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
Participants with Advanced Parkinson's Disease
Participants who along with their physicians have elected for treatment with Duodopa/Duopa and are prescribed according to the local product label and reimbursement guidelines for their participating countries.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Advanced Parkinson's disease
Criteria

Inclusion Criteria: - Eligibility for Duodopa/Duopa therapy in accordance with the approved local Duodopa/Duopa label in the participating country.

  • Duodopa/Duopa naïve participants
  • Decision to treat with Duodopa/Duopa made by the physician prior to any decision to approach the participant to participate in this study
  • Prior to any study-related procedures being performed, the participant, or legal authorized representative (LAR) has voluntarily signed an Authorization for Use/Disclosure of Data (AUDD)/informed consent form (ICF) according to national regulations after the study has been explained and the subject has had the opportunity to have questions answered.

Exclusion Criteria: - Any condition included in the contraindications section of the approved local Duodopa/Duopa label in the participating country.

  • Participants who have had previous surgery for PD including, but not limited to deep brain stimulation (DBS) or cell transplantation (this criterion removed for US sites).
  • Participants currently in treatment with continuous apomorphine infusion. In case of a previous treatment with continuous subcutaneous apomorphine infusion, there must be at least 4 weeks between discontinuation of this treatment and inclusion into this study.
  • Mini-Mental State Examination (MMSE) score <24
  • Participation in a concurrent interventional clinical trial.
  • Lack of motivation or insufficient language skills to complete the study questionnaires
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611713


Contacts
Contact: Debbie Cardoni, BS debbie.cardoni@abbive.com
Contact: Sabir Patel, MS sabir.patel@abbvie.com

  Show 65 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Lars Bergmann, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02611713     History of Changes
Other Study ID Numbers: P14-494
First Submitted: November 19, 2015
First Posted: November 23, 2015
Last Update Posted: November 7, 2017
Last Verified: November 2017

Keywords provided by AbbVie:
effectiveness
Caregiver Burden
motor and non-motor symptoms
Duodopa/Duopa
fluctuations
OFF time
carbidopa levodopa enteral suspension (CLES)
dyskinesia
Observational
tremor
levodopa-carbidopa intestinal gel (LCIG)
Quality of Life
Advanced Parkinson's Disease
Long-term

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists