NCT03607851

Brief Summary

Three different dose titration schedules are tested to find a way to reduce the titration period of lacosamide

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

August 3, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2019

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

July 24, 2018

Last Update Submit

February 16, 2020

Conditions

Focal Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.

    6 (rapid titration group) or 8 weeks (conventional titration group)

Secondary Outcomes (2)

  • Reduction of seizure frequency

    Baseline, 6 weeks (rapid titration group) or 8 weeks (conventional titration group)

  • lacosamide drug level in the blood

    2 weeks (rapid titration group) or 4 weeks (conventional titration group)

Study Arms (3)

Conventional titration group

ACTIVE COMPARATOR
Drug: Lacosamide - conventional titration

Rapid titration group 1

EXPERIMENTAL
Drug: Lacosamide - rapid titration 1

Rapid titration group 2

EXPERIMENTAL
Drug: Lacosamide - rapid titration 2

Interventions

Lacosamide - conventional titrationDRUG

Administration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose at weekly intervals by 50 mg PO BID; up to 200 mg BID

Conventional titration group
Lacosamide - rapid titration 1DRUG

Administration of lacosamide by the following schedule, Initial: 100 mg PO BID Increase dose to 200 mg BID after one week

Rapid titration group 1
Lacosamide - rapid titration 2DRUG

Administration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose every two days by 50 mg PO BID; up to 200 mg BID

Rapid titration group 2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-85 years old
  • Patients diagnosed with focal epilepsy
  • Patients subjected to the addition of lacosamide to treat focal onset seizures according to physician's judgement
  • Subjects provided informed consent

You may not qualify if:

  • Subjects who changed other antiepileptic drugs at the beginning of lacosamide treatment
  • Subjects with unstable physical, mental or other disease condition that can impede with accurate evaluation or treatment
  • Subjects with terminal illness or general medical condition that can impede with the participation of the clinical trial
  • Subjects who do not agree with prior consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (4)

  • Doty P, Hebert D, Mathy FX, Byrnes W, Zackheim J, Simontacchi K. Development of lacosamide for the treatment of partial-onset seizures. Ann N Y Acad Sci. 2013 Jul;1291(1):56-68. doi: 10.1111/nyas.12213.

    PMID: 23859801BACKGROUND

  • Ben-Menachem E, Biton V, Jatuzis D, Abou-Khalil B, Doty P, Rudd GD. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. Epilepsia. 2007 Jul;48(7):1308-17. doi: 10.1111/j.1528-1167.2007.01188.x.

    PMID: 17635557BACKGROUND

  • Halasz P, Kalviainen R, Mazurkiewicz-Beldzinska M, Rosenow F, Doty P, Hebert D, Sullivan T; SP755 Study Group. Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial. Epilepsia. 2009 Mar;50(3):443-53. doi: 10.1111/j.1528-1167.2008.01951.x. Epub 2009 Jan 17.

    PMID: 19183227BACKGROUND

  • Chung S, Sperling MR, Biton V, Krauss G, Hebert D, Rudd GD, Doty P; SP754 Study Group. Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial. Epilepsia. 2010 Jun;51(6):958-67. doi: 10.1111/j.1528-1167.2009.02496.x. Epub 2010 Jan 27.

    PMID: 20132285BACKGROUND

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2018

First Posted

July 31, 2018

Study Start

August 3, 2018

Primary Completion

June 7, 2019

Study Completion

June 7, 2019

Last Updated

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)