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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 is a Phase 4 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 59 participants.
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
Interventions
- DRUG Placebo
- DRUG Lacosamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2010-08 |
| Est. Completion | 2014-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01190098
The ClinicalTrials.gov registry entry for NCT01190098 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01190098 reports 0 study locations.
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.
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