Dystonia Clinical Trial
| NCT number | NCT00169403 |
| Other study ID # | P000201 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 3 |
| First received | September 12, 2005 |
| Last updated | August 28, 2007 |
Pallidal stimulation is effective in patients with generalised idiopathic dystonia. The aim
of this study is to:
1. evaluate the efficacy and safety of this treatment in patients with idiopathic
generalised dystonia, 3 years after surgery and
2. assess the recurrence of the motor symptoms after the switch off.
| Status | Recruiting |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 15 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Idiopathic generalised dystonia - Pallidal stimulation Exclusion Criteria: - Mini-mental status (MMS) < 24 - Severe psychiatric disorder |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Groupe Hospitalier Pitie-Salpetriere | Délégation Régionale à la Recherche Clinique |
France,
Vidailhet M, Vercueil L, Houeto JL, Krystkowiak P, Benabid AL, Cornu P, Lagrange C, Tézenas du Montcel S, Dormont D, Grand S, Blond S, Detante O, Pillon B, Ardouin C, Agid Y, Destée A, Pollak P; French Stimulation du Pallidum Interne dans la Dystonie (SPI — View Citation
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