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Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial

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NCT00407797

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Mexico, D. F., CP 06700 Mexico
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 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

- Male or Female who are diagnosed of partial seizure (simple partial, complex partial,
partial seizure secondarily generalized) as defined in the international league of
epilepsy classification of seizure.

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

- Patients having a treatable cause of seizure, currently receiving vigabatrin, having a
progressive neurological or systemic disorder.

NCT00407797
Pfizer
Terminated
Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial

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Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial
Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial. A Phase IV Open-Label Trial Using 150,300, 600 mg/Day Of Pregabalin
The purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED (Antiepileptic drugs).
This study was terminated on 17 March 2009 due to delayed enrollment. The decision to terminate the trial was not based on any safety concerns, but rather on timelines and the difficulty in enrolling patients in this open label, single group study.
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Partial Seizures
Drug: Pregabalin
150 to 600 mg/day during 21 weeks
Experimental: Pregabalin
Intervention: Drug: Pregabalin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
136
August 2009
August 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or Female who are diagnosed of partial seizure (simple partial, complex partial, partial seizure secondarily generalized) as defined in the international league of epilepsy classification of seizure.

Exclusion Criteria:

  • Patients having a treatable cause of seizure, currently receiving vigabatrin, having a progressive neurological or systemic disorder.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT00407797
A0081090
No
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2011

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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1-800-718-1021

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