NCT00655551 is a Phase 3 clinical trial of lacosamide in Partial Epilepsies, sponsored by UCB BIOSCIENCES, Inc..

Who is sponsoring NCT00655551?

NCT00655551 is sponsored by UCB BIOSCIENCES, Inc..

What drugs are being tested in NCT00655551?

Interventions in NCT00655551: lacosamide, lacosamide, lacosamide.

What condition does NCT00655551 study?

NCT00655551 studies Partial Epilepsies, Partial Onset Seizures.

Is NCT00655551 still recruiting?

NCT00655551 is currently completed. Last updated 20 June 2018.

Are results published for NCT00655551?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-06-20 · How we verify

NCT00655551

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter, Open-label Trial to Assess the Safety and Tolerability of a Single Intravenous Loading Dose of Lacosamide Followed by Oral Lacosamide Maintenance as Adjunctive Therapy in Subjects With Partial-onset Seizures

Completed Phase 3 Results posted Last updated 20 June 2018

What this trial tests

Phase 3 trial testing lacosamide in Partial Epilepsies in 100 participants. Completed in 1 September 2009.

Timeline

1 April 2008

Primary endpoint
1 September 2009

1 September 2009

Quick facts

Lead sponsor	UCB BIOSCIENCES, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 April 2008
Primary completion	1 September 2009
Estimated completion	1 September 2009
Sites	7 locations across United States

Drugs / interventions tested

lacosamide (lacosamide) — full drug profile →
lacosamide (lacosamide) — full drug profile →
lacosamide (lacosamide) — full drug profile →

Conditions studied

Partial Epilepsies — all drugs for Partial Epilepsies →
Partial Onset Seizures — all drugs for Partial Onset Seizures →

Sponsor

UCB BIOSCIENCES, Inc. — full company profile →

Who can join

Adults 16 to 60, any sex, with Partial Epilepsies or Partial Onset Seizures. 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.

Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)
Time frame: Treatment period (up to 7 days)
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medica
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
Time frame: Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication)
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medica

Sponsor's own description

The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with partial-onset seizures.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Development of lacosamide for the treatment of partial-onset seizures.
Doty P, Hebert D, Mathy FX, Byrnes W, et al · · 2013 · cited 41× · PMID 23859801 · DOI 10.1111/nyas.12213

Verify or expand the search:

Other trials of lacosamide

Trials testing the same drug.

NCT04737837 — A Real World Study on the Efficacy and Safety of Lacosamide as Add-on Therapy for Focal-onset Epilepsy · unknown
NCT03196466 — Population Pharmacokinetics of Antiepileptic in Pediatrics · completed
NCT01345058 — Add on Lacosamide Versus High Dose Monotherapy · Phase 3 · completed

Other UCB BIOSCIENCES, Inc. trials

Trials by the same sponsor.

NCT07503444 — A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome · Phase 3 · not yet recruiting
NCT06679413 — A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants · Phase 1 · completed
NCT06118255 — A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less · Phase 3 · active not recruiting
NCT03845712 — An Open-Label Study of Continuation Treatment With Combination Pyrimidine Nucleosides in Patients With TK2 Deficiency · Phase 2 · active not recruiting
NCT02710890 — Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children. · Phase 2, PHASE3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00655551 (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 BIOSCIENCES, Inc.
Last refreshed: 20 June 2018

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/NCT00655551.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing