Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
Status: | Terminated |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/5/2019 |
Start Date: | September 2007 |
End Date: | June 2011 |
A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by
itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment
of partial seizures. The duration of the trial is about 6 months.
itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment
of partial seizures. The duration of the trial is about 6 months.
After review of the interim analysis results, the independent Data Monitoring Committee (DMC)
recommended to stop the study based on positive efficacy findings for the primary efficacy
endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation
and made the decision to stop the study on September 7, 2011.
recommended to stop the study based on positive efficacy findings for the primary efficacy
endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation
and made the decision to stop the study on September 7, 2011.
Inclusion Criteria:
- Diagnosis of epilepsy with partial seizures.
- Males or females, age 18 years or older.
- Documented history of at least 4 partial seizures in the 8 weeks prior to the
screening visit.
- Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the
screening visit.
Exclusion Criteria:
- Current diagnosis of febrile seizures or seizures related to an ongoing acute medical
event.
- Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or
infectious origin.
- Primary generalized epilepsy or status epilepticus within the previous year.
We found this trial at
54
sites
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