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NCT00235469 · ClinicalTrials.gov registry record · Phase 2
A Trial to Assess the Efficacy and Safety of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy
A Phase 2 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 496
- Enrollment target
NCT00235469: Completed Phase 2 study, sponsored by UCB Pharma.
NCT00235469 is a Phase 2 study that has completed, run by UCB Pharma. The registered enrollment target is 496 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (273% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00235469, a Phase 2 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 496 participants
- Enrollment target
Study Summary
This phase 2b trial is being conducted at approximately 60 sites in the US to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 360 subjects will be randomized to placebo or one of three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of ≥4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to start of treatment. To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening), pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, safety and tolerability of the different doses of lacosamide will be investigated.
Interventions
- DRUG SPM 927
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 496 participants |
| Start Date | 2004-04 |
| Est. Completion | 2005-06 |
| Phase | Phase 2 |
What the finished NCT00235469 record still lists
NCT00235469 is an interventional study that assigns participants to a tested intervention. The registered 496 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 (273% higher).
The record links to 0 conditions, and to 1 intervention - of which SPM 927 is the first listed.
NCT00235469 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00235469 about?
NCT00235469 is a clinical study titled "A Trial to Assess the Efficacy and Safety of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy". This phase 2b trial is being conducted at approximately 60 sites in the US to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 360 subjects will be randomized to placebo or one of three doses of lacosamide. To qualify for th...
What is the current status of trial NCT00235469?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 496 participants. The study started on 2004-04. Estimated completion is 2005-06.
What interventions are being tested in trial NCT00235469?
The interventions under investigation include: SPM 927 (DRUG).
Who is sponsoring clinical trial NCT00235469?
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 NCT00235469's enrollment target sits among peer trials
496 75th of 2000 higher than 1,925 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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