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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