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NCT01190098 · ClinicalTrials.gov registry record · Phase 4
Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy
A Phase 4 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 59
- Enrollment target
NCT01190098: Completed Phase 4 study, sponsored by The Cleveland Clinic.
NCT01190098 is a Phase 4 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 59 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01190098, a Phase 4 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 59 participants
- Enrollment target
Study Summary
Sleepiness and fatigue are the most common complaints of people with epilepsy and can have a negative impact on quality of life. Though unproven, these problems are often blamed on anti-seizure medications. The purpose of this study is to investigate the impact of the anti-seizure medication Lacosamide (Vimpat®) on sleep and wakefulness in adults with focal (partial onset) seizures. Focal epilepsy, also called partial epilepsy, is a disorder characterized by seizures arising from a localized network of neurons in the brain. Focal seizures usually begin a sensation or involuntary movement of a part of the body, an unusual feeling, or a disturbance in hearing, smell, vision, or consciousness. The study is open to adults 18 and older with focal seizures. Participation involves a physical exam, sleep testing at the Sleep Center, blood tests, completion of study questionnaires/diaries, and a random assignment to either take the study drug or placebo (often called a "look alike" or "sugar pill") for 5 to 8 weeks. There are 5 study visits. Participants will receive compensation for time spent in the study. If you would like more information on this study please contact the Cleveland Clinic Sleep Center: Dr. Nancy Foldvary-Schaefer: 216-445-2990 Monica Bruton: 216-444-6718
Primary Outcome
Scale 0 - 24 Higher scores indicate more severe symptoms
Interventions
- DRUG Placebo
- DRUG Lacosamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2010-08 |
| Est. Completion | 2014-11 |
| Phase | Phase 4 |
What the finished NCT01190098 record still lists
NCT01190098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01190098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01190098 about?
NCT01190098 is a clinical study titled "Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy". Sleepiness and fatigue are the most common complaints of people with epilepsy and can have a negative impact on quality of life. Though unproven, these problems are often blamed on anti-seizure medications. The purpose of this study is to investigate the impact of the anti-seizure medication Lacosam...
What is the current status of trial NCT01190098?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 59 participants. The study started on 2010-08. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01190098?
The interventions under investigation include: Placebo (DRUG), Lacosamide (DRUG).
Who is sponsoring clinical trial NCT01190098?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01190098's enrollment target sits among peer trials
59 1202nd of 2000 higher than 796 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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