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Completed

NCT Number: NCT00603473

A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures

Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures

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Key information

Conditions

Epilepsies, Partial Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Obu-shi,Morioka-machi, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Japanese male or females, ages 3-15 years old at acquisition of informed consent, 15 years old or less at the baseline visit
  • Seizures are classified as simple partial, complex partial or partial becoming secondarily generalized (defined according to the International League Against Epilepsy)
  • Have not been able to achieve adequate seizure control with antiepileptic drugs

Exclusion criteria

  • Seizures related to drugs or acute medical illness
  • History of any serious medical or psychiatric disorder
  • Diagnosis or history of a structural CNS lesion or an encephalopathy shown to be progressive

Treatment and study plan

Gabapentin

Drug

Orally administered gabapentin

Primary outcomes

  1. Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures

    Time frame: 12 weeks

    The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T-B) / (T+B) where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period.

Secondary outcomes

  1. Responder Rate

    Time frame: 12 weeks

    Responder Rate was defined as the percentage of subjects with a 50% or greater reduction in the seizure frequency per 28 days for the 12-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period.

  2. Percent Change in Seizure Frequency (PCH)

    Time frame: 12 weeks

    PCH calculated by the following equation was assessed as secondary endpoint: PCH = 100 (T-B) / B where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

An Open-Label, Multicenter Study Evaluating, The Efficacy, Safety And Pharmacokinetics Of Gabapentin As Adjunctive Therapy In Pediatric Patients With Partial Seizures When Other Antiepileptics Do Not Provide Satisfactory Effects

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 29, 2008
Registry last updated
Feb 3, 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.

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