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NCT00235443 · ClinicalTrials.gov registry record · Phase 2
A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
A Phase 2 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 451
- Enrollment target
NCT00235443: Completed Phase 2 study, sponsored by UCB Pharma.
NCT00235443 is a Phase 2 study that has completed, run by UCB Pharma. The registered enrollment target is 451 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (239% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00235443, a Phase 2 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 451 participants
- Enrollment target
Study Summary
Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.
Primary Outcome
Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).
Interventions
- DRUG lacosamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 451 participants |
| Start Date | 2004-09 |
| Est. Completion | 2008-07 |
| Phase | Phase 2 |
What the finished NCT00235443 record still lists
NCT00235443 is an interventional study that assigns participants to a tested intervention. The registered 451 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (239% higher).
The record links to 0 conditions, and to 1 intervention - of which lacosamide is the first listed.
NCT00235443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00235443 about?
NCT00235443 is a clinical study titled "A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy". Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.
What is the current status of trial NCT00235443?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 451 participants. The study started on 2004-09. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00235443?
The interventions under investigation include: lacosamide (DRUG).
Who is sponsoring clinical trial NCT00235443?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00235443's enrollment target sits among peer trials
451 87th of 2000 higher than 1,914 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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