You are here

Once-A-Day Pregabalin For Partial Seizures

Last updated on March 25, 2018

FOR MORE INFORMATION
Study Location
Neurology Clinic, PC
Northport, Alabama, 35476 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Partial Seizures, 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 onset seizures (seizures may be simple or complex,
with or without evolution into a bilateral, convulsive seizure)

- Currently taking 1 to 3 anit-epilepsy medicines (AEDs) at stable dosages, and who have
taken at least 2 prior (or ongoing) AEDs

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

- Primary generalized seizures (for example, absence, myoclonic seizures or
Lennox-Gastaut Syndrome)

- Status epilepticus within one year prior to screening

NCT01262677
Pfizer
Completed
Once-A-Day Pregabalin For Partial Seizures

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Once-A-Day Pregabalin For Partial Seizures
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial Of Pregabalin Controlled Release Formulation As Adjunctive Therapy In Adults With Partial Onset Seizures - Protocol A0081194
Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Partial Seizures
  • Epilepsies, Partial
  • Drug: pregabalin
    Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
  • Drug: pregabalin
    Controlled Release Tablets, 165 mg, once per day (QD) for 11 days
  • Drug: pregabalin
    Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks)
  • Drug: pregabalin
    Controlled Release Tablets, 165 mg, once per day (QD) for 7 days
  • Drug: pregabalin
    Controlled Release Tablets, 165 mg, once per day (QD) for the remainder of the up-titration and double-blind treatment and taper phases (max 14.5 weeks)
  • Drug: placebo
    matched to the active drug
  • Experimental: pregabalin CR 330 mg
    Interventions:
    • Drug: pregabalin
    • Drug: pregabalin
    • Drug: pregabalin
    • Drug: pregabalin
  • Experimental: pregabalin CR 165 mg
    Interventions:
    • Drug: pregabalin
    • Drug: pregabalin
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
334
August 2012
August 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
  • Currently taking 1 to 3 anit-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs

Exclusion Criteria:

  • Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
  • Status epilepticus within one year prior to screening
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Bosnia and Herzegovina,   Bulgaria,   Czech Republic,   Germany,   Hong Kong,   Hungary,   India,   Malaysia,   Mexico,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Singapore,   Thailand,   United States
Croatia,   South Africa
 
NCT01262677
A0081194
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2013

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now