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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES - PROTOCOL A0081105

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Trial Profile

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES - PROTOCOL A0081105

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Aug 2023

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At a glance

  • Drugs Pregabalin (Primary)
  • Indications Tonic-clonic epilepsy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Pfizer

    • Most Recent Events

    • 30 May 2019 This trial has been completed in Greece, according to European Clinical Trials Database.
    • 24 May 2019 Primary endpoint has not been met. (Percent reduction in seizures), according to a Pfizer media release.
    • 24 May 2019 According to a Pfizer media release, this study was a post-marketing commitment to the U.S. Food and Drug Administration (FDA).
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