EpilepsyPhase 3NCT02582866
A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
A Phase 3 study testing Lacosamide in people with Epilepsy, run by UCB Biopharma S.P.R.L. at 46 sites in 15 countries.
Trial summary
Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in patients receiving LCM in SP0994 [NCT01465997]. The study will enable collection of additional monotherapy safety data, and will facilitate access to treatment until commercial availability for monotherapy use. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Epilepsy
- 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
- 106 participants
- Where
- 46 sitesin 15 countries
- Study dates
- Jan 2016to Jan 2020
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- An Institutional Review Board /Institutional Ethics Committee approved written Informed Consent Form (ICF) is signed and dated by the subject or by the parent(s) or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
- Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the investigator
- Subject has completed the Termination Visit of SP0994 [NCT01465997] and has been treated with lacosamide monotherapy
Who cannot join
- Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
- Subject experienced a seizure at the 3rd target dose (i.e. LCM 600 mg/day) during SP0994
- Subject required another Anti Epileptic Drug (AED) for the treatment of seizures
- Subject meets a "must" withdrawal criteria for SP0994
- Subject is experiencing an ongoing Serious Adverse Event from SP0994
- Female subject who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 year postmenopausal or does not practice one highly effective method of contraception, unless sexually abstinent, for the duration of the study
Trial locations and contacts
46 sites in 15 countries.
46 sites in 15 countries
Japan6 sites
Sp1042 831
Asaka
Sp1042 834
Kagoshima
Sp1042 844
Kamakura
Sp1042 835
Nagoya
Sp1042 837
Okayama
Sp1042 847
Sapporo
Russia6 sites
Sp1042 387
Kazan'
Sp1042 389
Kazan'
Sp1042 401
Moscow
Sp1042 392
Novosibirsk
Sp1042 397
Saint Petersburg
Sp1042 400
Saint Petersburg
Germany5 sites
Sp1042 263
Altenburg
Sp1042 265
Bad Neustadt an der Saale
Sp1042 269
Leipzig
Sp1042 256
Marburg
Sp1042 259
Osnabrück
South Korea4 sites
Sp1042 521
Daegu
Sp1042 518
Daejeon
Sp1042 517
Seoul
Sp1042 519
Seoul
About this study
Official title: A Multicenter, Open-label, Follow-up Study to Assess the Long-term Use of Lacosamide (Flexible Dose From 200 to 600 mg/Day) Used as Monotherapy in Subjects Who Completed SP0994 and Received Lacosamide Monotherapy Treatment
Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in patients receiving LCM in SP0994 [NCT01465997]. The study will enable collection of additional monotherapy safety data, and will facilitate access to treatment until commercial availability for monotherapy use.
- Conditions
- Epilepsy
- Being tested
- Lacosamide
- Keywords
- Lacosamide, Vimpat, Epilepsy, Partial onset seizures, Tonic-clonic seizures, Monotherapy, AED
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacosamideDrug
Also called Vimpat, SPM927, LCM
- Pharmaceutical Form: Oral tablets
- Concentration: 50 mg
- Route of Administration: Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide | Experimental | Lacosamide (LCM) will be administered orally twice daily from 200 mg/day to 600 mg/day (at approximately 12 hour intervals in the morning and in the evening) in 2 divided doses. Medication must not be chewed and must be swallowed with a sufficient amount of fluid. The investigator may maintain the subject's LCM dose, decrease the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increase the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.
Subjects stopping LCM should be tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper is permitted, if medically necessary; however, the maximum duration of tapering should not exceed 6 weeks. Receives: Drug: Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Measured: From Visit 1 (Week 0) to Final Visit (up to Week 158)
Percentage of Participants That Withdrew Due to Adverse Events (AEs)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Measured: From Visit 1 (Week 0) to Final Visit (up to Week 158)
Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
- Results in death
- Is life-threatening
- Requires in patient hospitalization or prolongation of existing hospitalization
- Is a congenital anomaly or birth defect
- Is an infection that requires treatment parenteral antibiotics
- Other important medical events which based on medical or scientific judgement may jeopardize the study participants, or may require medical or surgical intervention to prevent any of the above.
Measured: From Visit 1 (Week 0) to Final Visit (up to Week 158)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2020
- Study completionJan 2020
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 (2)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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582866
- Sponsor's protocol ID
- SP1042
- Other IDs
- 2015-001549-96, 2015
- Status last verified
- May 2023
- First submitted
- 20 Oct 2015
- Last updated
- 6 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ben-Menachem E, Dominguez J, Szasz J, Beller C, Howerton C, Jensen L, McClung C, Roebling R, Steiniger-Brach B. Long-term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open-label trial. Epilepsia Open. 2021 Sep;6(3):618-623. doi: 10.1002/epi4.12522. Epub 2021 Aug 2.
PubMed 34265173Inoue 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 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Follow-up Study to Assess the Long-term Use of Lacosamide (Flexible Dose From 200 to 600 mg/Day) Used as Monotherapy in Subjects Who Completed SP0994 and Received Lacosamide Monotherapy Treatment
- ClinicalTrials.gov ID
- NCT02582866
- Acronym / sponsor ID
- SP1042
- Conditions
- Epilepsy
- Keywords
- Lacosamide, Vimpat, Epilepsy, Partial onset seizures, Tonic-clonic seizures, Monotherapy, AED
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Posted 22 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in patients receiving LCM in SP0994 [NCT01465997]. The study will enable collection of additional monotherapy safety data, and will facilitate access to treatment until commercial availability for monotherapy use.
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 (LCM) will be administered orally twice daily from 200 mg/day to 600 mg/day (at approximately 12 hour intervals in the morning and in the evening) in 2 divided doses. Medication must not be chewed and must be swallowed with a sufficient amount of fluid. The investigator may maintain the subject's LCM dose, decrease the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increase the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Subjects stopping LCM should be tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper is permitted, if medically necessary; however, the maximum duration of tapering should not exceed 6 weeks. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- An Institutional Review Board /Institutional Ethics Committee approved written Informed Consent Form (ICF) is signed and dated by the subject or by the parent(s) or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
- Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the investigator
- Subject has completed the Termination Visit of SP0994 [NCT01465997] and has been treated with lacosamide monotherapy
Key exclusion criteria (6 listed)
- Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
- Subject experienced a seizure at the 3rd target dose (i.e. LCM 600 mg/day) during SP0994
- Subject required another Anti Epileptic Drug (AED) for the treatment of seizures
- Subject meets a "must" withdrawal criteria for SP0994
- Subject is experiencing an ongoing Serious Adverse Event from SP0994
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: Vimpat, SPM927, LCM* Pharmaceutical Form: Oral tablets * Concentration: 50 mg * Route of Administration: Oral administration | Drug | Lacosamide |
Primary outcome
Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
Time frame: From Visit 1 (Week 0) to Final Visit (up to Week 158)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Percentage of Participants That Withdrew Due to Adverse Events (AEs)
Time frame: From Visit 1 (Week 0) to Final Visit (up to Week 158)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
Time frame: From Visit 1 (Week 0) to Final Visit (up to Week 158)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the study participants, or may require medical or surgical intervention to prevent any of the above.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34265173Ben-Menachem E, Dominguez J, Szasz J, Beller C, Howerton C, Jensen L, McClung C, Roebling R, Steiniger-Brach B. Long-term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open-label trial. Epilepsia Open. 2021 Sep;6(3):618-623. doi: 10.1002/epi4.12522. Epub 2021 Aug 2.
- 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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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)
46 sites in 15 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, run by UCB Biopharma S.P.R.L. at 46 sites in 15 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 3 inclusion and 6 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 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Japan, Russia, Germany, South Korea, Bulgaria and 10 more countries. 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 22 Jan 2021). 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?
Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator (time frame: From Visit 1 (Week 0) to Final Visit (up to Week 158)). The study lists 3 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 NCT02582866, which also lists 2 linked publications.
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 6 Jun 2023.