EpilepsyPhase 3NCT01832038
Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
A Phase 3 study testing Lacosamide in people with Epilepsy and Partial-onset Seizures, run by UCB Pharma SA at 67 sites in 2 countries.
Trial summary
The purpose of this trial is to evaluate the safety and tolerability of long-term administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with Epilepsy who have completed the Treatment and Transition Period of EP0008 [NCT01710657] 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 473 participants
- Where
- 67 sitesin 2 countries
- Study dates
- 26 Mar 2013to 31 Jul 2019
- 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 completed the Treatment and Transition Period of EP0008 [NCT01710657]
Who cannot join
- Subjects who withdrew from EP0008 [NCT01710657]
Trial locations and contacts
67 sites in 2 countries.
67 sites in 2 countries
Japan37 sites
81056
Asaka
81013
Fukuoka
81054
Fukuoka
81057
Hachinohe
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
81005
Okayama
81011
Saitama
81042
Sakai
81025
Sapporo
81053
Sapporo
81009
Sayama
81021
Shimotsuke
81022
Shimotsuke
81026
Shinjuku
81003
Shizuoka
81023
Suita
81051
Suita
81006
Toyonaka
81050
Ube
81001
Yamagata
China30 sites
86026
Beijing
86027
Beijing
86015
Changchun
86005
Chengdu
86032
Chengdu
86006
Chongqing
86031
Dalian
86007
Guangzhou
86008
Guangzhou
86009
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
86020
Shijiazhuang
86022
Suzhou
86002
Taiyuan
86018
Wuhan
86024
Wuhan
86017
Xi'an
86029
Xiamen
About this study
Official title: A Multi-center, Open-label, Uncontrolled, Long-term, Extension Study to Evaluate the Safety and Efficacy of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Partial-onset Seizures With or Without Secondary Generalization
The purpose of this trial is to evaluate the safety and tolerability of long-term administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with Epilepsy who have completed the Treatment and Transition Period of EP0008 [NCT01710657]
- Conditions
- Epilepsy, Partial-onset Seizures
- Being tested
- Lacosamide
- 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.
LacosamideDrug
Also called Vimpat
Strength: Lacosamide (LCM) 50 mg, LCM 100 mg
Formulation: Tablet
Frequency: twice daily during the study period (until the date of approval)
At the completion of EP0008 [NCT01710657], all subjects who choose to enroll in EP0009 will be taking a dose of Lacosamide 200 mg/day. At the beginning of EP0009, the investigator may maintain the LCM dose or increase or decrease the dose. During the Treatment Period, the investigator will be allowed to increase or decrease the dose of LCM to optimize tolerability and seizure reduction. The LCM dose may be decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide | Experimental | Lacosamide treatment of 100 - 400 mg/day for long-term Receives: Drug: Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: From Visit 1 (Week 0) up to approximately Week 323
Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment and led to the withdrawal of the participants from the study. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: From Visit 1 (Week 0) up to approximately Week 323
Secondary outcomes (2)
Percent Change in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009
The percent change from Baseline to the Treatment Period was calculated as {[(Seizure frequency per 28 days during the Treatment Period) minus (Seizure frequency per 28 days during Baseline Period)] divided by (Seizure frequency per 28 days during Baseline Period)} multiplied by 100. Baseline was defined as the Baseline Period of study EP0008 [NCT01710657].
Measured: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009
Percentage of Participants With 50 % Response Rate in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009
A responder is a subject experiencing a greater than or equal to (≥) 50 % reduction in partial-onset seizure frequency per 28 days from baseline. Baseline was defined as the Baseline Period of study EP0008 [NCT01710657].
Measured: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study start26 Mar 2013
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UCB Japan Co. Ltd.
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832038
- Sponsor's protocol ID
- EP0009
- Status last verified
- Aug 2021
- First submitted
- 28 Mar 2013
- Last updated
- 17 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Inoue Y, Liao W, Wang X, Du X, Tennigkeit F, Sasamoto H, Osakabe T, Hoshii N, Yuen N, Hong Z. Safety and efficacy of adjunctive lacosamide in Chinese and Japanese adults with epilepsy and focal seizures: A long-term, open-label extension of a randomized, controlled trial. Epilepsy Res. 2021 Oct;176:106705. doi: 10.1016/j.eplepsyres.2021.106705. Epub 2021 Jun 29.
PubMed 34246118
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Uncontrolled, Long-term, Extension Study to Evaluate the Safety and Efficacy of Lacosamide as Adjunctive Therapy in Japanese and Chinese Adults With Partial-onset Seizures With or Without Secondary Generalization
- ClinicalTrials.gov ID
- NCT01832038
- Acronym / sponsor ID
- EP0009
- Conditions
- Epilepsy, Partial-onset Seizures
- Keywords
- Lacosamide, Epilepsy, Partial-onset Seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- UCB Pharma SAIndustry (pharma, biotech, devices)
- Collaborators
- UCB Japan Co. Ltd.
- Study start
- 26 Mar 2013 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Posted 13 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate the safety and tolerability of long-term administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with Epilepsy who have completed the Treatment and Transition Period of EP0008 [NCT01710657]
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lacosamide | Experimental | Drug: LacosamideLacosamide treatment of 100 - 400 mg/day for long-term |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subject has completed the Treatment and Transition Period of EP0008 [NCT01710657]
Key exclusion criteria (1 listed)
- Subjects who withdrew from EP0008 [NCT01710657]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LacosamideAlso: VimpatStrength: Lacosamide (LCM) 50 mg, LCM 100 mg Formulation: Tablet Frequency: twice daily during the study period (until the date of approval) At the completion of EP0008 [NCT01710657], all subjects who choose to enroll in EP0009 will be taking a dose of Lacosamide 200 mg/day. At the beginning of EP0009, the investigator may maintain the LCM dose or increase or decrease the dose. During the Treatment Period, the investigator will be allowed to increase or decrease the dose of LCM to optimize tolerability and seizure reduction. The LCM dose may be decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day. | Drug | Lacosamide |
Primary outcome
Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit
Time frame: From Visit 1 (Week 0) up to approximately Week 323
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit
Time frame: From Visit 1 (Week 0) up to approximately Week 323
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment and led to the withdrawal of the participants from the study. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
2 secondary outcomes
Percent Change in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009
Time frame: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009
Percentage of Participants With 50 % Response Rate in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009
Time frame: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34246118Inoue Y, Liao W, Wang X, Du X, Tennigkeit F, Sasamoto H, Osakabe T, Hoshii N, Yuen N, Hong Z. Safety and efficacy of adjunctive lacosamide in Chinese and Japanese adults with epilepsy and focal seizures: A long-term, open-label extension of a randomized, controlled trial. Epilepsy Res. 2021 Oct;176:106705. doi: 10.1016/j.eplepsyres.2021.106705. Epub 2021 Jun 29.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
+1 844 599 2273 (UCB)
67 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lacosamide in people with Epilepsy and Partial-onset Seizures, run by UCB Pharma SA at 67 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 1 inclusion and 1 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 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 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. 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 13 Aug 2020). 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?
Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit (time frame: From Visit 1 (Week 0) up to approximately Week 323). The study lists 2 primary outcomes in all. 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 NCT01832038, 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 17 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.