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Trial record 3 of 13 for:    Apomorphine Infusion

Personality, as a Predictive Factor of Therapeutic Response on Quality of Life After Continuous Perfusion of Dopaminergic Drugs, in Parkinson's Disease (PSYCHO-PERF)

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ClinicalTrials.gov Identifier: NCT03793491
Recruitment Status : Active, not recruiting
First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
The aim of the study is to evaluate if patients' personality could be considerate as predictive factor of quality of life after the establishment of continuous infusion of dopaminergic treatments to observe if there are predictive personality's profiles of specific therapeutic response (Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) or continuous infusion).

Condition or disease Intervention/treatment
Parkinson Disease Other: TCI scale Other: PDQ-39 scale

Detailed Description:
Parkinson's disease leads to quality of life degradation, especially at level of motor complications. Second line treatment can be proposed to patients. There are deep brain stimulation and two treatments by continuous perfusion: subcutaneous apomorphine infusion and intrajejunal infusion of levodopa-carbidopa. These treatments allow improvement of end-of-dose akinesia, dyskinesia, and a diminution of treatments per os. Nonetheless, they also lead to some side effects and complications. Currently, there are no scientific data to compare the efficacy of these two techniques on motor and non-motor symptoms. Choice is made according to the profile of the patient mainly based on side effects risks, and practitioner's habits. There are still no predictive factors clearly defined to judge of the best efficacy of these treatments according to the patients. Moreover, in an additional study named PSYCHO-STIM, the investigator have discovered that personality can be a predictive factor of quality of life amelioration 1 year after deep brain stimulation. It's why the investigator would like to test personality as a predictive factor of therapeutic response after both continuous perfusions that are available for the patients. Thus, patients beginning a treatment by subcutaneous apomorphine infusion or intrajejunal infusion of levodopa-carbidopa will be included. The investigator will evaluate their personality with the questionnaire "TCI" (Temperament and Character Inventory) and the investigator will assess their quality of life (PDQ-39), looking for the percentage of amelioration 6 months after the treatment by continuous infusion started. As secondary criteria, depression (HAMD), anxiety (HAMA), apathy (LARS), motility (MDS-UPDRS) and clinic severity (CGIS) will also be accessed before the treatment change and six months later.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study About Personality, as a Predictive Factor of Therapeutic Response on Quality of Life After Continuous Perfusion of Dopaminergic Drugs (by Subcutaneous Apomorphine Infusion or Intrajejunal Infusion of Levodopa-carbidopa), in Parkinson's Disease
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : December 18, 2020
Estimated Study Completion Date : June 18, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients having Parkinson's disease
Parkinson's patients presenting motor fluctuations and/or disabling dyskinesia and in need of the establishment of a second line treatment by subcutaneous apomorphine infusion or intrajejunal infusion of levodopa-carbidopa in the context of classical care of their Parkinson's disease. Patients will have TCI scale and PDQ-39 scale.
Other: TCI scale
TCI scale : Evaluation of the patient's personality with the TCI before that the treatment by continuous infusion started.
Other Names:
  • Temperament and Character Inventory scale (TCI)
  • Quality of life scale

Other: PDQ-39 scale
PDQ-39 scale: Comparison of life quality before and after the starting of he treatment by continuous infusion.
Other Name: Parkinson's Disease Questionnaire (PDQ-39)




Primary Outcome Measures :
  1. percent of improvement of quality of life score at 6 months after the beginning of the second line treatment [ Time Frame: day 1 ]
    Evaluation of life quality using Parkinson's Disease Questionnaire (PDQ-39) scale before (day 1) and after (6 month) the starting of perfusion treatment

  2. percent of improvement of quality of life score at 6 months after the beginning of the second line treatment [ Time Frame: 6 months ]
    Evaluation of life quality using PDQ-39 scale before and after the starting of perfusion treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parkinson patients
Criteria

Inclusion Criteria:

  • Patients having Parkinson's disease according to United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria
  • All Parkinson's patients presenting motor fluctuations and/or disabling dyskinesia and in need of the establishment of a second line treatment by subcutaneous apomorphine infusion or intrajejunal infusion of levodopa-carbidopa in the context of classical care of their Parkinson's disease
  • Patient able to give its free and informed consent
  • Patient having a social security

Exclusion Criteria:

  • Patients presenting atypical Parkinson's syndrome
  • Patients having a deep brain stimulation
  • Patient having a psychiatric disease such as: mood disorders, psychotic disorder…
  • Patients presenting a cognitive decline evaluated by a Montreal Cognitive Assessment (MoCA) score inferior to 24
  • None ability to give its consent
  • Patients unable to realize the tests provided in the context of this study
  • Patients under supervision, curators, or legal guardian
  • Patients non-affiliated to a social security
  • Patients in exclusion period of another study.

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): NCT03793491


Locations
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France
UHToulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Chrisitine BREFEL COURBON, PH University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03793491     History of Changes
Other Study ID Numbers: RC31/18/0390
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
continuous infusion
personality

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