EpilepsyPhase 3NCT00530855
Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
A Phase 3 study testing Lacosamide in people with Epilepsy, run by UCB Pharma at 108 sites in 9 countries.
Trial summary
This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902). Read more about this study
- Who is it for?
- Ages 16 to 70 years
- 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
- 322 participants
- Where
- 108 sitesin 9 countries
- Study dates
- Feb 2008to Dec 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 entered the Maintenance Phase of the double-blind trial, SP902, (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902; subject is allowed up to 2 concomitant Antiepileptic Drugs (AEDs)
Who cannot join
- Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)
Trial locations and contacts
108 sites in 9 countries.
108 sites in 9 countries
United States77 sites
048
Alabaster, Alabama
036
Albany, New York
161
Alexandria, Virginia
073
Ames, Iowa
003
Asheville, North Carolina
079
Atlanta, Georgia
060
Aurora, Colorado
138
Austin, Texas
020
Baltimore, Maryland
034
Baltimore, Maryland
024
Beaufort, South Carolina
010
Birmingham, Alabama
058
Boise, Idaho
083
Buffalo, New York
069
Cedarhurst, New York
016
Charlottesville, Virginia
114
Chattanooga, Tennessee
031
Chesterfield, Missouri
015
Cleveland, Ohio
061
Columbus, Ohio
022
Dallas, Texas
041
Detroit, Michigan
094
Doral, Florida
063
Durham, North Carolina
046
El Paso, Texas
025
Fairfield, Connecticut
108
Gainesville, Florida
030
Golden Valley, Minnesota
100
Greensburg, Pennsylvania
071
Hattiesburg, Mississippi
131
Hines, Illinois
051
Houston, Texas
053
Houston, Texas
078
Indianapolis, Indiana
102
Jonesboro, Arkansas
120
La Habra, California
136
Layton, Utah
017
Lebanon, New Hampshire
164
Lexington, Kentucky
007
Little Rock, Arkansas
086
Little Rock, Arkansas
059
Los Angeles, California
062
Louisville, Kentucky
080
Madison, Wisconsin
124
Manhattan, Kansas
123
Miami, Florida
132
Miami, Florida
001
Nashville, Tennessee
027
New York, New York
122
New York, New York
042
Northport, Alabama
147
Oklahoma City, Oklahoma
077
Orlando, Florida
049
Panama City, Florida
146
Peoria, Illinois
032
Philadelphia, Pennsylvania
009
Phoenix, Arizona
014
Phoenix, Arizona
151
Phoenix, Arizona
065
Pikesville, Maryland
129
Port Charlotte, Florida
074
Renton, Washington
098
San Antonio, Texas
021
Santa Monica, California
050
Sarasota, Florida
029
Scarborough, Maine
011
Springfield, Illinois
066
St Louis, Missouri
004
Tallahassee, Florida
002
Toledo, Ohio
107
Torrance, California
103
Tucson, Arizona
067
Voorhees Township, New Jersey
137
Waldorf, Maryland
023
Wichita, Kansas
160
Wichita, Kansas
117
Wilmington, North Carolina
Poland8 sites
284
Częstochowa
286
Gdansk
282
Gdynia
280
Krakow
290
Lublin
289
Szczecin
281
Warsaw
287
Warsaw
Canada7 sites
127
Calgary
091
Greenfield Park, Quebec
140
Halifax, Nova Scotia
116
Hamilton, Ontario
093
London, Ontario
110
Montreal, Quebec
113
Montreal, Quebec
Australia5 sites
420
Adelaide, South Australia
421
Capmerdown, New South Wales
425
Chatswood, New South Wales
423
Herston, Queensland
427
Parkville, Victoria
United Kingdom5 sites
360
Blackpool
367
Cornwall
364
London
369
London
363
Middlesbrough
About this study
Official title: A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects With Partial-onset Seizures
This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).
- Conditions
- Epilepsy
- Being tested
- Lacosamide
- Keywords
- Epilepsy, Partial-onset Seizures, Lacosamide, Monotherapy, Vimpat
- 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
50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide | Experimental | Lacosamide tablets for dosing 100 -800 mg/day Receives: Drug: Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study
Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
Measured: From Visit 1 to End of Study (approximately 2 years)
Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study
Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.
Measured: From Visit 1 to End of Study (approximately 2 years)
Secondary outcomes (2)
Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study
A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.
An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).
Measured: From Visit 1 to End of Study (approximately 2 years)
Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study
Measured: From Visit 1 to End of Study (approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startFeb 2008
- Primary completionDec 2014
- Study completionDec 2014
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.
- 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
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530855
- Sponsor's protocol ID
- SP0904
- Other IDs
- 2007-005440-25
- Status last verified
- Jul 2017
- First submitted
- 14 Sep 2007
- Last updated
- 18 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Expanded access
- Available
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, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects With Partial-onset Seizures
- ClinicalTrials.gov ID
- NCT00530855
- Acronym / sponsor ID
- SP0904
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Partial-onset Seizures, Lacosamide, Monotherapy, Vimpat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Sep 2007 (estimated)
- Results
- Posted 3 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).
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 tablets for dosing 100 -800 mg/day |
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 entered the Maintenance Phase of the double-blind trial, SP902, (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902; subject is allowed up to 2 concomitant Antiepileptic Drugs (AEDs)
Key exclusion criteria (1 listed)
- Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)
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: Vimpat50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years | Drug | Lacosamide |
Primary outcome
Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study
Time frame: From Visit 1 to End of Study (approximately 2 years)
Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study
Time frame: From Visit 1 to End of Study (approximately 2 years)
Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.
2 secondary outcomes
Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study
Time frame: From Visit 1 to End of Study (approximately 2 years)
Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study
Time frame: From Visit 1 to End of Study (approximately 2 years)
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.
- 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 Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
108 sites in 9 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 Pharma at 108 sites in 9 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 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 108 sites in United States, Poland, Canada, Australia, United Kingdom and 4 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 3 Jun 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?
Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study (time frame: From Visit 1 to End of Study (approximately 2 years)). 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?
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.