Epilepsies, Partial Clinical Trial
Official title:
Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures
| Verified date | March 2006 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | February 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin - Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening - Be currently taking 1 to 3 AEDs. Exclusion Criteria: - Have a treatable cause of seizures - Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Pfizer Investigational Site | Innsbruck | |
| Austria | Pfizer Investigational Site | Mauer Bei Amstetten | |
| Austria | Pfizer Investigational Site | St Polten | |
| Austria | Pfizer Investigational Site | Wien | |
| Canada | Pfizer Investigational Site | Barrie | Ontario |
| Canada | Pfizer Investigational Site | Calgary | Alberta |
| Canada | Pfizer Investigational Site | Edmonton | Alberta |
| Canada | Pfizer Investigational Site | Halifax | Nova Scotia |
| Canada | Pfizer Investigational Site | London | Ontario |
| Canada | Pfizer Investigational Site | Ottawa | Ontario |
| Canada | Pfizer Investigational Site | Trois Rivieres | Quebec |
| Canada | Pfizer Investigational Site | Vancouver | British Columbia |
| France | Pfizer Investigational Site | Colomiers | |
| France | Pfizer Investigational Site | Dommartin Les Toul | |
| France | Pfizer Investigational Site | Lille | Cedex |
| France | Pfizer Investigational Site | Marseille | Cedex 05 |
| France | Pfizer Investigational Site | Marseille Cedex 09 | |
| France | Pfizer Investigational Site | Montpellier | Cedex 5 |
| France | Pfizer Investigational Site | Paris | Cedex 13 |
| France | Pfizer Investigational Site | Rennes | Cedex |
| France | Pfizer Investigational Site | Strasbourg | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Bielefeld | |
| Germany | Pfizer Investigational Site | Bonn | |
| Germany | Pfizer Investigational Site | Essen | |
| Germany | Pfizer Investigational Site | Frankfurt | |
| Germany | Pfizer Investigational Site | Freiburg | |
| Germany | Pfizer Investigational Site | Goettingen | |
| Germany | Pfizer Investigational Site | Kehl | |
| Germany | Pfizer Investigational Site | Marburg | |
| Germany | Pfizer Investigational Site | ULM | |
| Italy | Pfizer Investigational Site | Firenze | |
| Italy | Pfizer Investigational Site | Perugia | |
| Italy | Pfizer Investigational Site | Pisa | |
| Italy | Pfizer Investigational Site | Siena | |
| Italy | Pfizer Investigational Site | Unknown | |
| Lithuania | Pfizer Investigational Site | Vilnius | |
| Lithuania | Pfizer Investigational Site | Vilnius | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Donostia-San Sebastian | |
| Spain | Pfizer Investigational Site | Gerona | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| United Kingdom | Pfizer Investigational Site | Fazakerley, Liverpool | |
| United Kingdom | Pfizer Investigational Site | Glascow | Scotland |
| United Kingdom | Pfizer Investigational Site | York |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Austria, Canada, France, Germany, Italy, Lithuania, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety assessments are performed at quarterly visits up until the study is closed. | |||
| Secondary | Seizure frequency is assessed throughout the study until the study is closed. |
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