Skip to main content
OpenTrials
Completed

NCT Number: NCT01747915

A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.

The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Generalized Tonic Clonic Seizures Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

5 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medizinische Universitaet Innsbruck, Innsbruck, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Seizures classified as Primary Generalized Tonic Clonic Seizures
  • Must have at least 1 PGTC seizure in the 8 weeks prior to screening
  • Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least 1 PGTC in each 4-week period of the baseline phase
  • Currently receiving adequate and stable dosage of 1 to 3 anti-epileptic treatments (stable within 28 days of screening)
  • Signed informed consent and assent if a minor
  • Ability to comply with daily seizure and dosing diary requirements and all study procedures

Exclusion criteria

  • A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness
  • Focal seizures (simple partial, complex partial, or partial becoming secondarily generalized)
  • Status Epilepticus within 1 year prior to screening
  • Lennox-Gastaut syndrome, infantile spasms, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome
  • Seizures related to drugs, alcohol, or acute medical illness
  • Any change in anti-epileptic treatment regimen (type of medication or dose; VNS alteration) within 28 days of the screening visit or during the baseline phase
  • Progressive or potentially progressive structural CNS lesion or a progressive encephalopathy.
  • Progressive inborn errors of metabolism.

Treatment and study plan

Pregabalin Dose Level 1

Drug

Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 300 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum dose of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.

Other names: Lyrica Dose Level 1

Pregabalin Dose Level 2

Drug

Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 600 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.

Other names: Lyrica Dose Level 2

Placebo

Drug

Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.

Primary outcomes

  1. Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase

    Time frame: Day 1 up to Week 12

    All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).

Secondary outcomes

  1. Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase

    Time frame: Day 1 up to Week 12

    Percentage of participants with 50% or greater reduction from baseline in 28-day seizure rate during the 12 week double blind treatment phase were reported. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2012
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.