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NCT01981447
IV Lacosamide: The Safety of Intravenous Lacosamide
Phase 3 trial testing IV Lacosamide in Epilepsy in 40 participants. Completed in 1 August 2012.
1 August 2012
Quick facts
| Lead sponsor | Le Bonheur Children's Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 April 2010 |
| Primary completion | 1 August 2012 |
| Estimated completion | 1 August 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- IV Lacosamide — full drug profile →
Conditions studied
- Epilepsy — all drugs for Epilepsy →
Sponsor
Le Bonheur Children's Hospital
Who can join
Adults 4 to 35, any sex, with Epilepsy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of participants with treatment-related adverse events (TEAEs), reported or observed.
Time frame: 2 years
Bradycardia, hypotension, fatigue, nausea, somnolence. -
Measure post-infusion lacosamide plasma concentrations
Time frame: 2 years
Serum lacosamide level drawn from the arm opposite intravenous infusion -
Measure changes in EKG, PR interval
Time frame: 2 years
PR interval changes measured in seconds
Sponsor's own description
The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01981447
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Epilepsy
Currently open trials in the same condition.
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- NCT07224191 — Hippocampal Oscillations During Exploration · NA · recruiting
- NCT07219407 — A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures · Phase 2 · recruiting
- NCT07417280 — LIFUS For Neurological Disorders · NA · recruiting
- NCT07490769 — Levetiracetam Three Times Daily in Epilepsy · Phase 3 · recruiting
Other Le Bonheur Children's Hospital trials
Trials by the same sponsor.
- NCT04905563 — NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures · Phase 4 · terminated
- NCT04205877 — The U.S. PDA Registry · not yet recruiting
- NCT04222101 — Association of Insulin Resistance and FGF21 on Cardiac Function in Pediatric Dilated Cardiomyopathy · NA · terminated
- NCT03897335 — Preventing Acute Kidney Injury (AKI) in Pediatric Patients · Phase 3 · unknown
- NCT03860012 — Folic Acid in Pediatric Inflammatory Bowel Disease · Phase 4 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01981447 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Le Bonheur Children's Hospital
- Last refreshed: 21 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01981447.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing