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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 July 31, 2018

FOR MORE INFORMATION
Study Location
Children's National Medical Center
Washington, District of Columbia, 20010 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
Recruiting
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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A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
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
This 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Partial Onset Seizures
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
123
April 30, 2018
April 30, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Month to 3 Years   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Argentina,   Belarus,   Belgium,   Bulgaria,   China,   France,   Germany,   Greece,   Hungary,   Israel,   Korea, Republic of,   Lebanon,   Malaysia,   Philippines,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine,   United States
Netherlands,   Poland,   South Africa
 
NCT02072824
A0081042
2013-003420-37 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

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

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