Trial document





This trial has been registered retrospectively.
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  DRKS00006735

Trial Description

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Title

Registry for Apomorphine-, L-Dopa-Infusiontherapy and Deep Brain Stimulation in Patients with Parkinson’s Disease

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Trial Acronym

Real-DBS-PD

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Parkinson's disease (PD) is characterized by the cardinal symptoms bradykinesia, rigidity, tremor and postural instability. However, also a multitude of non-motor symtoms like, e.g. neuropsychiatric, neuropsychological and autonomic symptoms may occur.
In patients with advanced PD conventional pharmacotherapy is complicated by dyskinesias and ON/OFF fluctuations.
Apomorphine and intra-jejunal l-dopa infusion therapy as well as deep brain stimulation enable a more continuous control of PD symptoms.
The aim of this registry is a systematical assessment of demographic data, hardware and procedure associated side effects as well as effects on quality of life, motor and non-motor symptoms.

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Brief Summary in Scientific Language

Parkinson's disease (PD) is characterized by motor symptoms (bradykinesia, rigidity, tremor and postural instability) and non-motor symptoms like, e.g. neuropsychiatric, neuropsychological and autonomic symptoms.
In patients with advanced PD conventional pharmacotherapy is complicated by dyskinesias and ON/OFF fluctuations.
A more steady control of PD symptoms is enable by continuous dopaminergic stimulation (Apomorphine and intra-jejunal l-dopa infusion therapy) and deep brain stimulation.
The aim of this registry is a systematical "real-life" assessment of demographic data, hardware and procedure associated side effects as well as effects on quality of life, motor and non-motor symptoms.

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Organizational Data

  •   DRKS00006735
  •   2014/10/08
  •   [---]*
  •   yes
  •   Approved
  •   12–145, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G20.00 -  [generalization G20: Parkinson disease]
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Interventions/Observational Groups

  •   Deep brain stimulation: demographic data, treatment application data and hardware and procedure associated side effects, motor and non-motor symptoms, quality of life
  •   Intra-jejunal levodopa infusion therapy: demographic data, treatment application data and hardware and procedure associated side effects, motor and non-motor symptoms, quality of life
  •   Subcutaneous Apomorphine infusion therapy: demographic data, treatment application data and hardware and procedure associated side effects, motor and non-motor symptoms, quality of life
  •   Conventional pharmaco-therapy: demographic data, treatment application data and hardware and procedure associated side effects, motor and non-motor symptoms, quality of life
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control, Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Non-motor (Non-motor Symptom Scale) and quality of life (Parkinson's Disease Questionnaire)

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Secondary Outcome

Demographic data, treatment application data and hardware and procedure associated side effects, motor and non-motor symptoms

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Countries of Recruitment

  •   Germany
  •   United Kingdom
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2012/07/15
  •   150
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

Patients with PD, diagnosed according to British Brain Bank criteria which are eligible for treatment with Apomorphine and intra-jejunal l-dopa infusion therapy and deep brain stimulation.

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Exclusion Criteria

- Clinically significant irregularities in the MRI scan like, e.g., strokes, cerebellar atrophy, and tumors.
- Clinically significant psychiatric diseases.
- Clinicallly significant neuropsychological impairments.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Department of NeurologyUniversity Hospital Cologne
    • Mr.  Prof. Dr.  Lars  Timmermann 
    • Kerpener Str. 62
    • 50937  Cologne
    • Germany
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    • Department of NeurologyUniversity Hospital Cologne
    • Mr.  Prof. Dr.  Lars  Timmermann 
    • Kerpenerstr. 62
    • 50937  Cologne
    • Germany
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    • Department of NeurologyUniversity Hospital Cologne
    • Mr.  Prof. Dr.  Lars  Timmermann 
    • Kerpenerstr. 62
    • 50937  Cologne
    • Germany
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Sources of Monetary or Material Support

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    • Department of NeurologyUniversity Hospital Cologne
    • Mr.  Prof. Dr.  Lars  Timmermann 
    • Kerpenerstr. 62
    • 50937  Cologne
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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