Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Lacosamide Long-Term Safety in Painful Diabetic Neuropathy
NCT00235443Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2004
- Primary completion
- Jul 2008
- Countries
- 1
- Sponsor
- UCB
- Modality
- Small Molecules
- Drugs
- lacosamide
- Conditions
- diabetic neuropathy
01
Overview
Phase 3, open-label, single-arm trial of lacosamide in diabetic neuropathy, sponsored by UCB. Primary endpoint: Number of Subjects With Adverse Events up to 2.8 years. Started Sep 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Lacosamide
Open-label lacosamide 100-600 mg/day
03
Who it enrols
Subjects with painful distal diabetic neuropathy who completed trials SP665, SP742, or SP768 and may benefit from long-term lacosamide treatment.
04
Endpoints
Primary
Number of Subjects With Adverse Events
Secondary
Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale
Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale
Patient's Global Impression of Change From Baseline in Pain
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale - Intensity
Change From Baseline in Average Pain Interference With Sleep
Change From Baseline in Average Pain Interference With Activity
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary
Beyond the preview
Go deeper on NCT00235443.
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 NCT00235443.