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A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.

Last updated on November 14, 2019

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Study Location
Pediatric Epilepsy Center of Central Florida
Orlando, Florida, 32819 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Partial Onset Seizures
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-3 month
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subject must have 3 partial onset seizures in the month prior to screening.

- Subject must have 2 partial onset seizures during the 48 hour baseline phase.

- Signed Informed Consent.

- On 1-3 stable anti-epileptic drugs at screening.

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

- Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile
seizures, and infantile spasms.

- Lennox-Gasteau, BECTS, and Dravet's syndrome.

- Status epliepticus within 1 year of screening.

- Any change in AED regimen with 7 days of screening.

- Progressive structural central nervous system (CNS) lesion or a progressive
encephalopathy.

- Progressive errors of metabolism.

NCT02072824
Pfizer
Completed
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.

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Descriptive Information
Brief Title  ICMJE A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
Official Title  ICMJE A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 1 Month Through <4 Years Of Age With Partial Onset Seizures
Brief SummaryThis study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Partial Onset Seizures
Intervention  ICMJE
  • Drug: Pregabalin Dose Level 1
    Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
  • Drug: Pregabalin Dose Level 2
    Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
  • Drug: Placebo
    Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase
Study Arms  ICMJE
  • Experimental: Study Drug Level 1
    Intervention: Drug: Pregabalin Dose Level 1
  • Experimental: Study Drug Level 2
    Intervention: Drug: Pregabalin Dose Level 2
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *Not Provided


*   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: July 16, 2018)
175
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2014)
123
Actual Study Completion Date  ICMJE March 13, 2018
Actual Primary Completion DateMarch 13, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must have 3 partial onset seizures in the month prior to screening.
  • Subject must have 2 partial onset seizures during the 48 hour baseline phase.
  • Signed Informed Consent.
  • On 1-3 stable anti-epileptic drugs at screening.

Exclusion Criteria:

  • Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms.
  • Lennox-Gasteau, BECTS, and Dravet's syndrome.
  • Status epliepticus within 1 year of screening.
  • Any change in AED regimen with 7 days of screening.
  • Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy.
  • Progressive errors of metabolism.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 1 Month to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus,   Belgium,   Bosnia and Herzegovina,   Bulgaria,   China,   France,   Germany,   Greece,   Hungary,   Israel,   Korea, Republic of,   Lebanon,   Malaysia,   Philippines,   Romania,   Russian Federation,   Serbia,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine,   United States
Removed Location CountriesArgentina,   Netherlands,   Poland,   Singapore,   Slovakia,   South Africa
 
Administrative Information
NCT Number  ICMJE NCT02072824
Other Study ID Numbers  ICMJE A0081042
2013-003420-37 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
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 DateSeptember 2018

ICMJE     Data element required by the

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

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