Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01110187 · ClinicalTrials.gov registry record · NA
A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide
A NA study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT01110187: Clinical Trial NA study, sponsored by University of Alabama at Birmingham.
NCT01110187 is a NA study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01110187, a NA study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
Trial to determine if seizure prophylaxis with IV LCM in NSICU patients experiencing mental status changes due to severe traumatic brain injury (sTBI) will result in improved short- and long-term outcomes and better immediate adverse effects when compared to the current standard of care anticonvulsant (IV fPHT) and will be at least as effective as IV fPHT in preventing clinical and sub-clinical seizure activity.
Primary Outcome
The primary outcome measure is the incidence of clinical adverse events. These will be followed by daily clinical observations during the hospital stay. Subjects will be evaluated for e.g., seizures, fever, neurological changes, cardiovascular, hematologic and dermatologic abnormalities, liver failure, renal failure, and death; EKGs will be requested as per ICU routines through day 7.
Interventions
- DRUG lacosamide
- DRUG Fosphenytoin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-05 |
| Phase | NA |
Why NCT01110187 stopped before completion
NCT01110187 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which lacosamide is the first listed.
NCT01110187 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01110187 about?
NCT01110187 is a clinical study titled "A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide". Trial to determine if seizure prophylaxis with IV LCM in NSICU patients experiencing mental status changes due to severe traumatic brain injury (sTBI) will result in improved short- and long-term outcomes and better immediate adverse effects when compared to the current standard of care anticonvulsa...
What is the current status of trial NCT01110187?
This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2010-05. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01110187?
The interventions under investigation include: lacosamide (DRUG), Fosphenytoin (DRUG).
Who is sponsoring clinical trial NCT01110187?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01110187's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03114462 · 11 participants · Phase 1
Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
- NCT06039709 · 11 participants · Phase 1
Sonodynamic Therapy in Patients With Recurrent GBM
- NCT06425380 · 11 participants · NA
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
- NCT06472661 · 11 participants · Early Phase 1
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia