Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Topiramate for Lennox-Gastaut Syndrome
NCT00004776Phase 3
Key facts
- Status
- Completed
- Start
- Nov 1993
- Sponsor
- National Center for Research Resources
- Modality
- Small Molecules
- Drugs
- topiramate
- Conditions
- Lennox-Gastaut syndrome (LGS)
01
Overview
Phase 3, randomised, double-blind trial in Lennox-Gastaut syndrome (LGS) comparing Topiramate with Placebo (2 arms). Primary endpoint: Percent reduction in drop attacks from baseline at 11 weeks. Started Nov 1993; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Topiramate
Oral topiramate titrated to maintenance dose + concurrent AEDs
Placebo
Placebo + concurrent AEDs
03
Who it enrols
Patients with Lennox-Gastaut syndrome having at least 60 seizures/month (atypical absence and drop attacks), on 1-2 concurrent AEDs, weighing at least 11.5 kg.
04
Endpoints
Primary
Percent reduction in drop attacks from baseline
Secondary
Responder rate (>=50% reduction in drop attacks)
Parental Global Evaluation
Percent reduction in major motor seizures
Beyond the preview
Go deeper on NCT00004776.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00004776.