EpilepsyPhase 3NCT01465997
Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
A Phase 3 study testing Lacosamide in people with Epilepsy and Monotherapy, run by UCB BIOSCIENCES GmbH at 150 sites in 29 countries.
Trial summary
Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy, Monotherapy
- 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
- 551 participants
- Where
- 150 sitesin 29 countries
- Study dates
- May 2012to Jan 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject/legal representative is considered reliable and capable of adhering to the protocol
- Subject has remained seizure free and completed the Maintenance Phase of the SP0993; or subject has experienced 1 or more seizures on the first or second target dose during the SP0993 Maintenance Phase
- Subject is expected to benefit from participation in SP0994 in the opinion of the investigator
Who cannot join
- Subject is receiving any investigational drugs or using any experimental devices in addition to LCM or CBZ-CR
- Subject experienced a seizure at the third target dose during the Evaluation Phase or Maintenance Phase of the SP0993 study
- Subject is taking benzodiazepines for a non-epilepsy indication
- Subject meets a withdrawal criterion from the previous study SP0993
- Subject is experiencing an ongoing SAE from the previous study SP0993
- Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has 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. Or subject has a positive response (Yes) to either Question 4 or Question 5 of the C-SSRS at Screening in the "Since Last Visit" version
Trial locations and contacts
150 sites in 29 countries.
150 sites in 29 countries
Russia11 sites
387
Kazan'
389
Kazan'
396
Kirov
394
Moscow
401
Moscow
390
Nizhny Novgorod
392
Novosibirsk
397
Saint Petersburg
400
Saint Petersburg
386
Smolensk
399
Yaroslavl
Japan10 sites
831
Asaka-shi
833
Hamamatsu
834
Kagoshima
844
Kamakura-shi
843
Miyazaki
835
Nagoya
837
Okayama
828
Saitama-shi
847
Sapporo
832
Shizuoka
United States9 sites
786
Alabaster, Alabama
799
Huntsville, Alabama
777
Little Rock, Arkansas
790
Madison, Wisconsin
881
Mansfield, Texas
794
Oklahoma City, Oklahoma
789
Panama City, Florida
776
Port Charlotte, Florida
873
Raleigh, North Carolina
Germany9 sites
263
Altenburg
265
Bad Neustadt an der Saale
257
Berlin
262
Berlin
270
Berlin
260
Göttingen
269
Leipzig
256
Marburg
259
Osnabrück
Spain9 sites
422
Badalona
413
Barcelona
417
Girona
416
Madrid
425
Madrid
419
San Cristóbal de La Laguna
418
San Sebastián
414
Santiago de Compostela
424
Seville
Hungary8 sites
289
Balassagyarmat
283
Budapest
284
Budapest
286
Debrecen
282
Győr
285
Szeged
290
Szekszárd
291
Szombathely
South Korea8 sites
525
Busan
521
Daegu
518
Daejeon
517
Seoul
519
Seoul
520
Seoul
523
Seoul
524
Seoul
Australia7 sites
104
Chatswood
105
Clayton
106
East Gosford
101
Fitzroy
108
Heidelberg
103
Herston
109
Randwick
Romania7 sites
576
Bucharest
569
Cluj-Napoca
570
Iași
579
Iași
571
Sibiu
577
Sibiu
572
Târgu Mureş
Slovakia7 sites
594
Dolný Kubín
598
Dubnica nad Váhom
596
Hlohovec
600
Krompachy
595
Levoča
599
Tornaľa
601
Žilina
Bulgaria6 sites
805
Blagoevgrad
807
Panagyurishte
803
Pleven
810
Rousse
811
Sofia
809
Veliko Tarnovo
Portugal5 sites
360
Coimbra
362
Lisbon
365
Lisbon
366
Porto
361
Santa Maria da Feira
Canada4 sites
152
Greenfield Park
158
Halifax Nova Scotia
156
Hamilton
153
St. John's
About this study
Official title: A Multicenter, Double-blind, Double-dummy, Follow up Study Evaluating the Long-term Safety of Lacosamide in Comparison With Controlled-release Carbamazepine Used as Monotherapy in Subjects With Partial-onset or Generalized Tonic-clonic Seizures ≥16 Years of Age Coming From the SP0993 Study.
Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs).
- Conditions
- Epilepsy, Monotherapy
- Being tested
- Lacosamide, Carbamazepine-Controlled Release (CBZ-CR)
- Keywords
- Lacosamide
- 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 film-coated tablets
50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Carbamazepine-Controlled Release (CBZ-CR)Drug
Also called Tegretol® Retard Tablets 200 mg
200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum 3.5 Years)
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide | Experimental | 50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years) Receives: Drug: Lacosamide |
| Carbamazepine-Controlled Release (CBZ-CR) | Active comparator | 200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years) Receives: Drug: Carbamazepine-Controlled Release (CBZ-CR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
Measured: Up to 3.5 Years (Duration of the Treatment Phase)
Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
Measured: Up to 3.5 Years (Duration of the Treatment Phase)
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)
A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.
Measured: Up to 3.5 Years (Duration of the Treatment Phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startMay 2012
- Primary completionJan 2017
- Study completionJan 2017
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 551 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eden Sarl
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465997
- Sponsor's protocol ID
- SP0994
- Other IDs
- 2010-021238-74
- Status last verified
- Sep 2017
- First submitted
- 2 Nov 2011
- Last updated
- 18 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Expanded access
- Available
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 34265173
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Double-dummy, Follow up Study Evaluating the Long-term Safety of Lacosamide in Comparison With Controlled-release Carbamazepine Used as Monotherapy in Subjects With Partial-onset or Generalized Tonic-clonic Seizures ≥16 Years of Age Coming From the SP0993 Study.
- ClinicalTrials.gov ID
- NCT01465997
- Acronym / sponsor ID
- SP0994
- Conditions
- Epilepsy, Monotherapy
- Keywords
- Lacosamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Eden Sarl
- Study start
- May 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Posted 2 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lacosamide | Experimental | Drug: Lacosamide50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years) |
| Carbamazepine-Controlled Release (CBZ-CR) | Active comparator | Drug: Carbamazepine-Controlled Release (CBZ-CR)200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subject/legal representative is considered reliable and capable of adhering to the protocol
- Subject has remained seizure free and completed the Maintenance Phase of the SP0993; or subject has experienced 1 or more seizures on the first or second target dose during the SP0993 Maintenance Phase
- Subject is expected to benefit from participation in SP0994 in the opinion of the investigator
Key exclusion criteria (6 listed)
- Subject is receiving any investigational drugs or using any experimental devices in addition to LCM or CBZ-CR
- Subject experienced a seizure at the third target dose during the Evaluation Phase or Maintenance Phase of the SP0993 study
- Subject is taking benzodiazepines for a non-epilepsy indication
- Subject meets a withdrawal criterion from the previous study SP0993
- Subject is experiencing an ongoing SAE from the previous study SP0993
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 film-coated tablets50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years) | Drug | Lacosamide |
| Carbamazepine-Controlled Release (CBZ-CR)Also: Tegretol® Retard Tablets 200 mg200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum 3.5 Years) | Drug | Carbamazepine-Controlled Release (CBZ-CR) |
Primary outcome
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)
Time frame: Up to 3.5 Years (Duration of the Treatment Phase)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)
Time frame: Up to 3.5 Years (Duration of the Treatment Phase)
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)
Time frame: Up to 3.5 Years (Duration of the Treatment Phase)
A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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.
- 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
+1 877 822 9493 (UCB)
150 sites in 29 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 Monotherapy, run by UCB BIOSCIENCES GmbH at 150 sites in 29 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 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 150 sites in Russia, Japan, United States, Germany, Spain and 24 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 2 Aug 2017). 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 Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years) (time frame: Up to 3.5 Years (Duration of the Treatment Phase)). 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 NCT01465997, 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 18 Jul 2018.