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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.

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ClinicalTrials.gov Identifier: NCT02072824
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Partial Onset Seizures Drug: Pregabalin Dose Level 1 Drug: Pregabalin Dose Level 2 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: Study Drug Level 1 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

Experimental: Study Drug Level 2 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

Placebo Comparator: Placebo Drug: Placebo
Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase




Primary Outcome Measures :
  1. Percent reduction of 24 hour seizure rate for all partial onset seizures relative to placebo during the double-blind assessment phase. [ Time Frame: Video-EEG recordings for a target minimum of 48 hours ]
    Percent reduction of partial onset seizures during the double-blind assessment phase, collected by video-EEG recording.


Secondary Outcome Measures :
  1. Responder rate, defined as the proportion of subjects who had at least a 50% reduction in 24 hour partial onset seizure rate. [ Time Frame: calculated from 48 hour basline through the 2 week double-blind treatment phase ]
    The proportion of subjects who have at least a 50% reduction in 24 hour partial onset seizure rate during the double-blind assessment phase, as measured from baseline (data collected during the 48 hour baseline video-EEG phase).



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Ages Eligible for Study:   1 Month to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072824


  Show 72 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02072824     History of Changes
Other Study ID Numbers: A0081042
2013-003420-37 ( EudraCT Number )
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Partial Onset Seizures
Epilepsy
Safety
Efficacy
Tolerability
Pregabalin
Lyrica
Adjunctive treatment
Placebo controlled
blinded
Eligibility Criteria

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs