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Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

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NCT00524030

Last updated on March 22, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Northport, Alabama, 35476 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Partial Epilepsies
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00524030
Pfizer
Terminated
Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

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Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Epilepsies, Partial
  • Drug: pregabalin 600 mg/day
    pregabalin 600 mg/day (300mg BID), duration is 20 weeks.
  • Drug: pregabalin 150 mg/day
    pregabalin 150 mg/day (75mg BID), duration is 20 weeks.
  • Experimental: 1
    Intervention: Drug: pregabalin 600 mg/day
  • Experimental: 2
    Intervention: Drug: pregabalin 150 mg/day
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
161
June 2011
April 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Hong Kong,   Ukraine,   United States
 
 
NCT00524030
A0081047
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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