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COMPLETED Phase 3

Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy

NCT00232596 · View on ClinicalTrials.gov ↗

Study Summary

This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Retigabine

Study Locations (20)

Alabama

  • University of Alabama -- Department of Neurology/Epilepsy Center — Birmingham
  • North Alabama Neuroscience Research Associates — Huntsville
  • Neurology Clinic — Northport

California

  • UCSD Thornton Hospital — La Jolla
  • University of Southern California — Los Angeles
  • West Los Angeles VA Healthcare Center — Los Angeles

Florida

  • University of Florida -- Shands Jacksonville — Jacksonville
  • University of Miami — Miami
  • Lovelace Scientific Resources — Sarasota

Colorado

  • Delta Waves — Colorado Springs
  • University of Colorado Health Science Center — Denver

Arizona

  • Barrow Neurological Institute — Phoenix

Arkansas

  • Clinical Trials Inc. — Little Rock

Iowa

  • McFarland Clinic — Ames

Kentucky

  • University of Kentucky — Lexington

Trial Details

FieldValue
Enrollment Target 306 participants
Start Date 2005-09
Est. Completion 2008-01
Phase Phase 3

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00232596

The ClinicalTrials.gov registry entry for NCT00232596 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 306 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Seizures appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00232596 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Alabama, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00232596 about?

NCT00232596 is a clinical study titled "Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy". This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).

What is the current status of trial NCT00232596?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 306 participants. The study started on 2005-09. Estimated completion is 2008-01.

What conditions does trial NCT00232596 study?

This clinical trial studies the following conditions: Seizures. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00232596?

The interventions under investigation include: Placebo (DRUG), Retigabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00232596?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00232596 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial