NCT01175954 is a Phase 4 clinical trial of Lacosamide in Epilepsy, sponsored by Evan Fertig.

Who is sponsoring NCT01175954?

NCT01175954 is sponsored by Evan Fertig.

What drugs are being tested in NCT01175954?

Interventions in NCT01175954: Lacosamide, Lacosamide.

Is NCT01175954 still recruiting?

NCT01175954 is currently completed. Last updated 12 September 2017.

Last reviewed 2017-09-12 · How we verify

NCT01175954

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

Phase IV Study of Cognitive and Behavioral Effects of Lacosamide as Adjunctive Therapy in Patients With Partial Epilepsy

Completed Phase 4 Last updated 12 September 2017

What this trial tests

Phase 4 trial testing Lacosamide in Epilepsy in 32 participants. Completed in 1 December 2015.

Timeline

1 May 2010

Primary endpoint
1 December 2015

1 December 2015

Quick facts

Lead sponsor	Evan Fertig
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	1 May 2010
Primary completion	1 December 2015
Estimated completion	1 December 2015
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

Epilepsy — all drugs for Epilepsy →

Sponsor

Evan Fertig

Who can join

Adults 18 to 70, any sex, with Epilepsy. 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.

Changes in Cognitive test scores
Time frame: 30 weeks
Changes in the composite measure of the cognitive test scores and in the composite measure of the mood/Quality Of Life scores from baseline (visit 1) to scores recorded at termination (visit 4).

Sponsor's own description

Primary Objective: Null hypothesis: A 24-week trial of adjunctive Lacosamide does not produce a decline in cognitive, mood or quality of life measures. To determine the cognitive and behavioral side effects of lacosamide in patients with partial epilepsy and follow them for a period of 24 weeks using a neuropsychological test battery drawing on tests commonly used and designed to maximize sensitivity to drug effects. Secondary Objectives: To determine if any significant changes in cognitive, mood or quality of life measures are dependent upon changes in seizure severity, neurotoxicity, adverse events, or Lacosamide dosage.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The effects of lacosamide on cognition, quality-of-life measures, and quality of life in patients with refractory partial epilepsy.
Lancman ME, Fertig EJ, Trobliger RW, Perrine K, et al · · 2016 · cited 21× · PMID 27315132 · DOI 10.1016/j.yebeh.2016.04.049
Clinical stabilisation with lacosamide of mood disorder comorbid with PTSD and fronto-temporal epilepsy.
Cuomo I, Kotzalidis GD, De Filippis S. · · 2017 · cited 5× · PMID 28845834 · DOI 10.23750/abm.v88i2.5232

Verify or expand the search:

Other trials of Lacosamide

Trials testing the same drug.

NCT06969417 — Comparative Efficacy of Pregabalin and Lacosamide in Patients With Herpes Zoster and Post Herpetic Neuralgia · NA · recruiting
NCT05603702 — STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis · Phase 1 · recruiting
NCT05510856 — Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Indu · Phase 4 · completed
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

Other recruiting trials for Epilepsy

Currently open trials in the same condition.

NCT07095933 — The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy · EARLY_PHASE1 · recruiting
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

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 NCT01175954 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Evan Fertig
Last refreshed: 12 September 2017

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/NCT01175954.

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