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EpilepsyPhase 3NCT01710657

A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures

A Phase 3 study testing Lacosamide 50 mg and Lacosamide 100 mg in people with Epilepsy and Partial Onset Seizures, run by UCB Pharma SA at 76 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary generalization. Read more about this study

Who is it for?
Ages 16 to 70 years
Conditions the study is for
Epilepsy, Partial Onset Seizures
What is being tested?
Lacosamide 50 mg and Lacosamide 100 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
548 participants
Where
76 sitesin 2 countries
Study dates
Sep 2012to Aug 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subject has had an Electroencephalogram (EEG) and a brain Computerized Tomography (CT) scan or Magnetic Resonance Imaging (MRI) exam consistent with a Diagnosis of Epilepsy with Partial-Onset Seizures according to the International Classification of Epileptic Seizures (1981)
  • Subject must have been observed to have Partial-Onset Seizures for at least the previous 2 years despite prior therapy with at least 2 Anti-Epileptic Drugs (AEDs)(concurrently or sequentially) and must have been observed to have on average at least 4 Partial-Onset Seizures per 28 days with a seizure-free phase no longer than 21 days in the 8-Week Period prior to entry into the Baseline Period. In the case of Simple Partial Seizures, only those with motor signs will be counted towards meeting the inclusion criterion
  • Subjects must be on a stable dose regimen of at least 1, but no more than 3 AEDs (concurrent stable Vagus Nerve Stimulation (VNS) is not counted as an AED). The VNS must have been in place for at least 6 months prior to study entry. The dosage of concomitant AED therapy and the settings of the VNS must be kept constant for a period of at least 4 weeks prior to entry into the Baseline Period
  • Minimum Body Weight of 40 kg

Who cannot join

  • Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt) or has a suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
  • Subject has a current or previous diagnosis of Pseudo-Seizures, Conversion Disorders, or other non-epileptical events that could be confused with Seizures
  • Subject has Seizures that are uncountable due to Clustering (ie, an episode lasting less than 30 minutes in which several Seizures occur with such frequency that the initiation and completion of each individual Seizure cannot be distinguished) during the 8-Week Period prior to Visit 1
  • Subject has a history of Primary Generalized Seizures
  • Subject with a history of Status Epilepticus within the 12-Months Period prior to Visit 1
  • Subject who underwent surgery for Epilepsy within the 2 Years Period prior to Visit 1
  • Subjects with cardiac, renal, hepatic, endocrinological dysfunction or psychiatric illness that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol

Trial locations and contacts

76 sites in 2 countries.

76 sites in 2 countries

Japan45 sites

  • 81056

    Asaka

  • 81030

    Fujisawa

  • 81013

    Fukuoka

  • 81054

    Fukuoka

  • 81057

    Hachinohe

  • 81008

    Hakodate

  • 81027

    Hamamatsu

  • 81004

    Himeji

  • 81018

    Hiroshima

  • 81019

    Iwanuma

  • 81012

    Kagoshima

  • 81033

    Kitakyushu

  • 81017

    Kobe

  • 81024

    Kodaira

  • 81010

    Kokubunji

  • 81032

    Kōshi

  • 81014

    Kurume

  • 81047

    Kyoto

  • 81035

    Nagakute

  • 81028

    Nagoya

  • 81029

    Nagoya

  • 81040

    Nara

  • 81007

    Neyagawa

  • 81002

    Niigata

  • 81046

    Ohmura

  • 81005

    Okayama

  • 81011

    Saitama

  • 81042

    Sakai

  • 81025

    Sapporo

  • 81048

    Sapporo

  • 81053

    Sapporo

  • 81009

    Sayama

  • 81020

    Sendai

  • 81031

    Sendai

  • 81021

    Shimotsuke

  • 81022

    Shimotsuke

  • 81026

    Shinjuku

  • 81003

    Shizuoka

  • 81023

    Suita

  • 81051

    Suita

  • 81052

    Suita

  • 81016

    Takatsuki

  • 81006

    Toyonaka

  • 81050

    Ube

  • 81001

    Yamagata

Other trials in Japan

China31 sites

  • 86026

    Beijing

  • 86027

    Beijing

  • 86015

    Changchun

  • 86005

    Chengdu

  • 86032

    Chengdu

  • 86006

    Chongqing

  • 86031

    Dalian

  • 86009

    Guanghzou

  • 86007

    Guangzhou

  • 86008

    Guangzhou

  • 86013

    Guangzhou

  • 86016

    Guangzhou

  • 86014

    Hangzhou

  • 86010

    Harbin

  • 86019

    Jinan

  • 86004

    Kunming

  • 86011

    Nanchang

  • 86012

    Nanchang

  • 86028

    Nanjing

  • 86003

    Qingdao

  • 86001

    Shanghai

  • 86023

    Shanghai

  • 86025

    Shanghai

  • 86021

    Shenyang

  • 86020

    Shijiazhuang

  • 86022

    Suzhou

  • 86002

    Taiyuan

  • 86018

    Wuhan

  • 86024

    Wuhan

  • 86017

    Xi'an

  • 86029

    Xiamen

Other trials in China

About this study

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Uncontrolled Partial-Onset Seizures With or Without Secondary Generalization

The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary generalization.

Being tested
Lacosamide 50 mg, Lacosamide 100 mg, Placebo
Keywords
Lacosamide, Epilepsy, Partial Onset Seizures
Medical subject headings
Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lacosamide 50 mgDrug

    Also called Vimpat

    • Active Substance: Lacosamide
    • Pharmaceutical Form: Film-coated tablet
    • Concentration: 50 mg
    • Route of Administration: Oral use

  • Lacosamide 100 mgDrug

    Also called Vimpat

    • Active Substance: Lacosamide
    • Pharmaceutical Form: Film-coated tablet
    • Concentration: 100 mg
    • Route of Administration: Oral use

  • PlaceboDrug

    Matching oral Placebo tablets twice daily for 16 weeks.

Study groups in NCT01710657
Study groupRoleWhat they receive
PlaceboPlacebo comparatorMatching placebo for 16 weeks.
Receives: Drug: Placebo
Lacosamide 200 mg/dayExperimentalLacosamide treatment of 200 mg/day (100 mg bid (twice daily)) for 16 weeks.
Receives: Drug: Lacosamide 50 mg; Drug: Lacosamide 100 mg
Lacosamide 400 mg/dayExperimentalLacosamide treatment of 400 mg/day (200 mg bid (twice daily)) for 16 weeks.
Receives: Drug: Lacosamide 50 mg; Drug: Lacosamide 100 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period

    Partial-onset seizure (POS) frequency per 28 days was calculated as:

    POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.

    A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period.

    Measured: 8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)

Secondary outcomes (3)

  1. The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)

    Measured: 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)

  2. Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period

    Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.

    Measured: 8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)

  3. Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)

    Partial-onset seizure (POS) frequency per 28 days was calculated as:

    POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.

    A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period.

    Measured: 8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionJul 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
548 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01710657
Sponsor's protocol ID
EP0008
Other IDs
2014-003622-41, JapicCTI-121988, 2014
Status last verified
Jul 2017
First submitted
17 Oct 2012
Last updated
25 Aug 2017
Data monitoring committee
No

Publications

  • 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.

    PubMed 23859801

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lacosamide 50 mg and Lacosamide 100 mg in people with Epilepsy and Partial Onset Seizures, run by UCB Pharma SA at 76 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in Japan, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period (time frame: 8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01710657, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.

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