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Once-A-Day Pregabalin For Partial Seizures

Last updated on October 10, 2019

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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

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Partial Epilepsies
NCT00351611
All Genders
18+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE Once-A-Day Pregabalin For Partial Seizures
Official Title  ICMJE 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
Brief SummaryApproximately 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Partial Seizures
  • Epilepsies, Partial
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *French J, Brandt C, Friedman D, Biton V, Knapp L, Pitman V, Chew M, Dubrava S, Posner HB. Adjunctive use of controlled-release pregabalin in adults with treatment-resistant partial seizures: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014 Aug;55(8):1220-8. doi: 10.1111/epi.12690. Epub 2014 Jun 24.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2018)
325
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2010)
333
Actual Study Completion Date  ICMJE August 1, 2012
Actual Primary Completion DateJuly 31, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 anti-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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bosnia and Herzegovina,   Bulgaria,   Czechia,   Germany,   Hong Kong,   Hungary,   India,   Malaysia,   Mexico,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Singapore,   Thailand,   United States
Removed Location CountriesCroatia,   Czech Republic,   South Africa
 
Administrative Information
NCT Number  ICMJE NCT01262677
Other Study ID Numbers  ICMJE A0081194
2010-019035-35 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2018

ICMJE     Data element required by the

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

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