Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Collaborator:
Délégation Régionale à la Recherche Clinique
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:
NCT00169403
First received: September 12, 2005
Last updated: August 28, 2007
Last verified: September 2005
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 12, 2005 | ||||||||
| Last Updated Date | August 28, 2007 | ||||||||
| Start Date ICMJE | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00169403 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 | Pallidal Stimulation in Patients With Idiopathic Generalised Dystonia | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| Brief Summary | Pallidal stimulation is effective in patients with generalised idiopathic dystonia. The aim of this study is to:
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Dystonia | ||||||||
| Intervention ICMJE | Procedure: Deep brain stimulation | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Vidailhet M, Vercueil L, Houeto JL, Krystkowiak P, Benabid AL, Cornu P, Lagrange C, Tezenas du Montcel S, Dormont D, Grand S, Blond S, Detante O, Pillon B, Ardouin C, Agid Y, Destee A, Pollak P; French Stimulation du Pallidum Interne dans la Dystonie (SPIDY) Study Group. Bilateral deep-brain stimulation of the globus pallidus in primary generalized dystonia. N Engl J Med. 2005 Feb 3;352(5):459-67. | ||||||||
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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 | Recruiting | ||||||||
| Enrollment ICMJE | Not Provided | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 15 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00169403 | ||||||||
| Other Study ID Numbers ICMJE | P000201 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Groupe Hospitalier Pitie-Salpetriere | ||||||||
| Collaborators ICMJE | Délégation Régionale à la Recherche Clinique | ||||||||
| Investigators ICMJE |
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| Information Provided By | Groupe Hospitalier Pitie-Salpetriere | ||||||||
| 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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