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NCT00955357 · ClinicalTrials.gov registry record · Phase 4
Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
A Phase 4 study of Partial Epilepsies, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 4
- Development phase
- 461
- Enrollment target
- 20
- Study locations
NCT00955357: Completed Phase 4 study of Partial Epilepsies, sponsored by UCB Pharma.
NCT00955357 is a Phase 4 study of Partial Epilepsies that has completed, run by UCB Pharma. The registered enrollment target is 461 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00955357, a Phase 4 study of Partial Epilepsies, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 461 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.
Primary Outcome
A subject will be considered seizure-free if the subject completes the first 12 weeks of the Maintenance Phase, reports zero seizures, and has no seizure data missing for any day during the period of time. This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn.
Conditions Studied
Interventions
- DRUG Lacosamide
Study Locations (20)
Georgia
- 108 - Atlanta
- 112 - Atlanta
- 124 - Augusta
- 115 - Macon
- 118 - Rome
Florida
- 156 - Clearwater
- 157 - Destin
- 140 - Hollywood
- 161 - Ocala
California
- 103 - Irvine
- 123 - Rancho Mirage
Kentucky
- 102 - Bowling Green
- 117 - Paducah
Louisiana
- 107 - Houma
- 145 - Ruston
Maryland
- 101 - Annapolis
- 162 - Waldorf
Illinois
- 128 - Flossmoor
Iowa
- 130 - Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 461 participants |
| Start Date | 2009-08 |
| Est. Completion | 2013-08 |
| Phase | Phase 4 |
What the finished NCT00955357 record still lists
NCT00955357 is an interventional study that assigns participants to a tested intervention. The registered 461 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (11% lower).
The record links to 1 condition, with Partial Epilepsies appearing as the primary indexed condition, and to 1 intervention - of which Lacosamide is the first listed.
NCT00955357 names 20 study sites across 9 states, led by Georgia, Florida, California.
Frequently Asked Questions
What is clinical trial NCT00955357 about?
NCT00955357 is a clinical study titled "Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures". To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.
What is the current status of trial NCT00955357?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 461 participants. The study started on 2009-08. Estimated completion is 2013-08.
What conditions does trial NCT00955357 study?
This clinical trial studies the following conditions: Partial Epilepsies.
What interventions are being tested in trial NCT00955357?
The interventions under investigation include: Lacosamide (DRUG).
Who is sponsoring clinical trial NCT00955357?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00955357 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00955357's enrollment target sits among peer trials
461 184th of 2000 higher than 1,817 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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