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NCT00135109 · ClinicalTrials.gov registry record · Phase 3
Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy
A Phase 3 study of Diabetic Neuropathies, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 654
- Enrollment target
- 1
- Study location
NCT00135109 is a Phase 3 study of Diabetic Neuropathies that has completed, run by UCB Pharma. The registered enrollment target is 654 participants, above the 246-participant average among 8 other Diabetic Neuropathies trials with a reported enrollment target (166% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00135109, a Phase 3 study of Diabetic Neuropathies, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 654 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase 3 trial is being conducted at approximately 80 sites in the United States (U.S.) to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 455 subjects will be randomized to placebo or to 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 greater than or equal to 4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to the 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; and pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, the safety and tolerability of the different doses of lacosamide will be investigated.
Conditions Studied
Interventions
- DRUG SPM 927
Study Locations (1)
North Carolina
- Schwarz - RTP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 654 participants |
| Start Date | 2004-10 |
| Est. Completion | 2005-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00135109
The ClinicalTrials.gov registry entry for NCT00135109 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 654 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 246-participant average among 8 other Diabetic Neuropathies trials with a reported enrollment target (166% higher). The listed sponsor is UCB Pharma, which has 100 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetic Neuropathies appearing as the primary indexed condition, and to 1 intervention - of which SPM 927 is the first listed.
NCT00135109 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT00135109 about?
NCT00135109 is a clinical study titled "Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy". This phase 3 trial is being conducted at approximately 80 sites in the United States (U.S.) to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 455 subjects will be randomized to placebo or to one of three doses of lacosamid...
What is the current status of trial NCT00135109?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 654 participants. The study started on 2004-10. Estimated completion is 2005-12.
What conditions does trial NCT00135109 study?
This clinical trial studies the following conditions: Diabetic Neuropathies.
What interventions are being tested in trial NCT00135109?
The interventions under investigation include: SPM 927 (DRUG).
Who is sponsoring clinical trial NCT00135109?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00135109 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.