STN-Stimulation Versus Best Medical Treatment in Advanced PD
This study has been completed.
Sponsor:
German Parkinson Study Group (GPS)
Information provided by:
German Parkinson Study Group (GPS)
ClinicalTrials.gov Identifier:
NCT00196911
First received: September 11, 2005
Last updated: November 29, 2006
Last verified: September 2005
| Tracking Information | |||||
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| First Received Date ICMJE | September 11, 2005 | ||||
| Last Updated Date | November 29, 2006 | ||||
| Start Date ICMJE | January 2001 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00196911 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | STN-Stimulation Versus Best Medical Treatment in Advanced PD | ||||
| Official Title ICMJE | Randomized, Multicenter, Prospective, Parallel-Group Study of the Effect of Deep Brain Stimulation (Subthalamic Nucleus) on Quality of Life and Motor Complications in Patients With Advanced Parkinson's Disease Compared With Best Medical Treatment | ||||
| Brief Summary | Assessment of the therapeutic effect of deep brain stimulation of the subthalamic nucleus compared with drug treatment alone in patients with advanced Parkinson's disease. |
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| Detailed Description | Patients are randomized either to medical treatment or subthalamic stimulation. The observation period was 6 months. The primary outcome criterium: PDQ-39 and UPDRS III. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Parkinson's Disease | ||||
| Intervention ICMJE | Procedure: Implantation of stimulation electrodes in the STN | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 156 | ||||
| Completion Date | January 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: advanced Parkinson's disease with UPDRS III score >29/104 or Dyskinesia score > 2 or tremor >2 Exclusion Criteria: age>75 years depression psychosis surgical contraindications |
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| Gender | Both | ||||
| Ages | 20 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00196911 | ||||
| Other Study ID Numbers ICMJE | A 125/00, Grant 01 GI 0201/01 GI 0401 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | German Parkinson Study Group (GPS) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | German Parkinson Study Group (GPS) | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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