Seizures Clinical Trial
Official title:
Pregabalin In Partial Seizures (Preps) : An Open-Label, International, Multicenter Add-On Therapy Trial
| NCT number | NCT00141427 |
| Other study ID # | A0081005 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | November 2004 |
| Est. completion date | May 2006 |
| Verified date | June 2006 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To assess the clinical improvement (change in seizure frequency), safety and tolerability of patients with partial seizures following adjunctive therapy of pregabalin BID in addition to existing standard AEDs.
| Status | Completed |
| Enrollment | 540 |
| Est. completion date | May 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Male and female subjects with a diagnosis of partial epilepsy. - 18 years and older. Exclusion Criteria: - Having a treatable cause of seizure. - Having a progressive neurological or systemic disorder |
| Country | Name | City | State |
|---|---|---|---|
| Pfizer Investigational Site | |||
| Belgium | Pfizer Investigational Site | Brugge | |
| Belgium | Pfizer Investigational Site | Brussels | |
| Belgium | Pfizer Investigational Site | Duffel | |
| Belgium | Pfizer Investigational Site | Gent | |
| Belgium | Pfizer Investigational Site | Leuven | |
| Belgium | Pfizer Investigational Site | Liege | |
| Belgium | Pfizer Investigational Site | Tielt | |
| Belgium | Pfizer Investigational Site | Yvoir | |
| Finland | Pfizer Investigational Site | Helsinki | |
| Finland | Pfizer Investigational Site | Kuopio | |
| Finland | Pfizer Investigational Site | Tampere | |
| France | Pfizer Investigational Site | Bayonne | |
| France | Pfizer Investigational Site | Bordeaux Cedex | |
| France | Pfizer Investigational Site | Grenoble Cedex | |
| France | Pfizer Investigational Site | Lille Cedex | |
| France | Pfizer Investigational Site | Lyon | Cedex |
| France | Pfizer Investigational Site | Marseille | |
| France | Pfizer Investigational Site | Marseille | Cedex 05 |
| France | Pfizer Investigational Site | Montpellier | Cedex 5 |
| France | Pfizer Investigational Site | Nancy | |
| France | Pfizer Investigational Site | Nice Cedex | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | Rennes | |
| France | Pfizer Investigational Site | Strasbourg | |
| France | Pfizer Investigational Site | Toulouse | |
| France | Pfizer Investigational Site | Tours | |
| Netherlands | Pfizer Investigational Site | Alkmaar | |
| Netherlands | Pfizer Investigational Site | Breda | |
| Netherlands | Pfizer Investigational Site | Den Haag | ZH |
| Netherlands | Pfizer Investigational Site | Heeze | |
| Netherlands | Pfizer Investigational Site | Hilversum | |
| Netherlands | Pfizer Investigational Site | Oss | |
| Netherlands | Pfizer Investigational Site | Southwest Heemstede | |
| Poland | Pfizer Investigational Site | Katowice | |
| Poland | Pfizer Investigational Site | Krakow | |
| Poland | Pfizer Investigational Site | Lublin | |
| Poland | Pfizer Investigational Site | Warszawa | |
| Poland | Pfizer Investigational Site | Warszawa | |
| Poland | Pfizer Investigational Site | Warszawa | |
| Poland | Pfizer Investigational Site | Wroclaw | |
| Portugal | Pfizer Investigational Site | Braga | |
| Portugal | Pfizer Investigational Site | Funchal | |
| Portugal | Pfizer Investigational Site | Lisboa | |
| Portugal | Pfizer Investigational Site | Matosinhos | |
| Portugal | Pfizer Investigational Site | Ponta Delgada | |
| Portugal | Pfizer Investigational Site | Porto | |
| Switzerland | Pfizer Investigational Site | Lausanne | |
| Switzerland | Pfizer Investigational Site | Zurich | |
| Switzerland | Pfizer Investigational Site | Zurich | |
| United Kingdom | Pfizer Investigational Site | Cambridge | Cambs |
| United Kingdom | Pfizer Investigational Site | Glasgow | |
| United Kingdom | Pfizer Investigational Site | Oxford | |
| United Kingdom | Pfizer Investigational Site | Plymouth | Devon |
| United Kingdom | Pfizer Investigational Site | Truro | Cornwall |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
Belgium, Finland, France, Netherlands, Poland, Portugal, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reduction in seizure frequency. |
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