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Pregabalin Versus Levetiracetam In Partial Seizures

Last updated on December 17, 2017

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Study Location
Pfizer Investigational Site
Duffel, , B-2570 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Partial Seizures
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

- Subjects (male or female) must be > 18 years of age, with a diagnosis of epilepsy with
partial seizures, as defined in the International League Against Epilepsy (ILAE)
classification of seizures.

- Partial seizures may be simple or complex, with or without secondary tonic-clonic
generalization.

- Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have
been unresponsive to treatment with at least two but no more than five prior
antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages
of 1 or 2 standard AEDs.

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

- Females who are pregnant, breastfeeding, or intend to become pregnant during the
course of the trial will be excluded

- Subjects with other neurologic illness that could impair endpoint assessment, or
subjects with Lennox-Gastaut syndrome, absence seizures, status epileptics within the
12 months prior to trial entry, or with seizures due to an underlying medical illness
or metabolic syndrome, will be excluded.

NCT00537238
Pfizer
Completed
Pregabalin Versus Levetiracetam In Partial Seizures

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Pregabalin Versus Levetiracetam In Partial Seizures
A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures
This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Partial Seizures
  • Drug: pregabalin
    300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
  • Drug: levetiracetam
    1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
  • Active Comparator: B
    Intervention: Drug: pregabalin
  • Active Comparator: A
    Intervention: Drug: levetiracetam
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
509
May 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects (male or female) must be > 18 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures.
  • Partial seizures may be simple or complex, with or without secondary tonic-clonic generalization.
  • Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.

Exclusion Criteria:

  • Females who are pregnant, breastfeeding, or intend to become pregnant during the course of the trial will be excluded
  • Subjects with other neurologic illness that could impair endpoint assessment, or subjects with Lennox-Gastaut syndrome, absence seizures, status epileptics within the 12 months prior to trial entry, or with seizures due to an underlying medical illness or metabolic syndrome, will be excluded.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Bulgaria,   Colombia,   Costa Rica,   Czech Republic,   France,   Germany,   Greece,   India,   Italy,   Korea, Republic of,   Lithuania,   Mexico,   Panama,   Peru,   Philippines,   Russian Federation,   Spain,   Taiwan,   Turkey,   Venezuela
 
 
NCT00537238
A0081157
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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