Last reviewed · How we verify
NCT01673282: VICTOS
A Non-interventional, Observational Study Evaluating Changes in Drug Load and Seizure Frequency Using Vimpat (Lacosamide) in Daily Clinical Practice in Combination Therapy With Sodium Channel Blocking Anti-epileptic Drugs (AEDs) or Non Sodium Channel Blocking AEDs
trial testing Lacosamide in Focal Epilepsy With and Without Secondary Generalization in 315 participants. Completed in 1 July 2015.
1 July 2015
Quick facts
| Lead sponsor | UCB Pharma GmbH |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 315 |
| Start date | 1 July 2012 |
| Primary completion | 1 July 2015 |
| Estimated completion | 1 July 2015 |
| Sites | 42 locations across Austria, Germany |
Drugs / interventions tested
- Lacosamide (lacosamide) — full drug profile →
Conditions studied
- Focal Epilepsy With and Without Secondary Generalization — all drugs for Focal Epilepsy With and Without Secondary Generalization →
Sponsor
UCB Pharma GmbH
Who can join
18 and older, any sex, with Focal Epilepsy With and Without Secondary Generalization. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months)
Time frame: From Baseline (Day 0) to 6 months
Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.
Sponsor's own description
This observational study aims to investigate how VIMPAT® is used as adjunctive therapy in clinical practice and will also evaluate the subsequent change in the drug load of patients after addition of VIMPAT® to their treatment regimen.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Changes in drug load during lacosamide combination therapy: A noninterventional, observational study in German and Austrian clinical practice.
Reinhardt F, Weber YG, Mayer T, Luef G, et al · · 2019 · cited 5× · PMID 31440722 · DOI 10.1002/epi4.12346
Verify or expand the search:
- PubMed search for NCT01673282
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of Lacosamide
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- NCT05291455 — Lacosamide in Neonatal Status Epilepticus · Phase 3 · unknown
- NCT04627285 — A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) · Phase 3 · completed
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 NCT01673282 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by UCB Pharma GmbH
- Last refreshed: 26 September 2016
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/NCT01673282.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing