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`Page 1 of 11
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`Clinical Study Information - Vimpat® (lacosamide)
`
`Back to the overview page [/rd/clinical-study-information]
`
`Abbreviated title Phase Study ID Registry database
`
`Study results
`
`Study
`summary
`
`P
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`B 2
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`0
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`Phase EP0008
`
`NCT01710657
`3
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT01710657?
`term=NCT01710657&rank=1]
`
`Phase EP0009
`
`3
`Ongoing
`
`NCT01832038
`[https://clinicaltrials.gov/ct2/show/study/NCT01832038?
`term=NCT01832038&rank=1]
`
`A Study to
`Evaluate the
`Efficacy and
`Safety of
`Adjunctive
`Therapy With
`Lacosamide in
`Adults With
`Partial Onset
`Seizures
`
`Study to Evaluate
`the Safety,
`Tolerability, and
`Efficacy of Long-
`term Adjunctive
`Therapy With
`Lacosamide in
`Adults With
`Partial-onset
`Seizures
`
`NCT02192814
`[https://clinicaltrials.gov/ct2/show/study/NCT02192814?
`term=NCT02192814&rank=1]
`
`NCT01964560
`[https://clinicaltrials.gov/ct2/show/study/NCT01964560?
`term=NCT01964560&rank=1]
`2012-005012-26
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2012-005012-26]
`
`NCT02124564
`[https://clinicaltrials.gov/ct2/show/study/NCT02124564?
`term=NCT02124564&rank=1]
`
`Phase EP0024
`
`Open-label Study
`3
`Ongoing
`to Evaluate the
`Safety and
`Tolerability of iv
`Lacosamide in
`Japanese Adults
`With Partial-onset
`Seizures
`
`Phase EP0034
`
`3
`Ongoing
`
`Long-term
`Extension Study
`to Investigate
`Lacosamide as an
`Add-on Therapy
`in Children With
`Partial Onset
`Seizures
`
`Phase EP0057
`
`A Trial to Evaluate
`3
`Ongoing
`the Long Term
`Safety and
`Tolerability of
`Lacosamide
`Taken as
`Monotherapy in
`Adults With
`Partial-onset
`Seizures
`
`Phase SP0615
`
`NCT00552305
`2
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00552305?
`term=NCT00552305&rank=1]
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT00552305?
`term=NCT00552305&rank=1]
`
`To Determine
`Tolerability and
`Efficacy of Long-
`term Oral
`Lacosamide in
`Patients With
`Partial Seizures
`
`Phase SP0616
`
`NCT00800215
`2
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00800215?
`term=NCT00800215&rank=1]
`
`A Trial to
`Investigate the
`Safety,
`Tolerability and
`Pharmacokinetics
`of Intravenous
`SPM 927 (n/a)
`
`
`Disease area
`studied
`
`Epilepsy
`
`Epilepsy
`
`Epilepsy
`
`Epilepsy
`
`Epilepsy
`
`Epilepsy
`
`Epilepsy
`
`http://www.ucb.com/rd/clinical-study-information/vimpat-lacosamide
`
`6/8/2015
`
`ARGENTUM Exhibit 1186
`Argentum Pharmaceuticals LLC v. Research Corporation Technologies, Inc.
`IPR2016-00204
`
`00001
`
`
`
`Lacosamide (Vimpat®) | UCB
`
`Disease area
`studied
`
`Neuropathic
`Pain
`
`Page 2 of 11
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`Study
`summary
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`W 2
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`G N 1
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`Abbreviated title Phase Study ID Registry database
`
`Study results
`
`Phase SP0647
`
`NCT00237458
`An Open-label
`2
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00237458?
`Continuation
`term=NCT00237458&rank=1]
`Trial to Assess the
`Continued
`Efficacy and
`Safety of
`Ascending Doses
`of Lacosamide in
`Subjects With
`Chronic
`Refractory
`Neuropathic Pain
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT00237458?
`term=NCT00237458&rank=1]
`
`Phase SP0665
`
`NCT00861042
`2
`
`Completed [https://clinicaltrials.gov/ct2/show/NCT00861042?
`term=NCT00861042&rank=1]
`
`Phase SP0690
`
`NCT00238511
`2
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00238511?
`term=NCT00238511&rank=1]
`
`
`Phase SP0742
`
`NCT00235469
`2
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00235469?
`term=NCT00235469&rank=1]
`
`
`Phase SP0743
`
`NCT00238524
`3
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00238524?
`term=NCT00238524&rank=1]
`
`
`Neuropathic
`Pain
`
`Postherpetic
`Neuralgia
`
`Neuropathic
`Pain
`
`Neuropathic
`Pain
`
`An Open-label
`follow-on Trial to
`Assess the Long-
`term Safety and
`Efficacy of Oral
`SPM 927 in
`Subjects With
`Diabetic
`Neuropathy
`
`An Open-Label
`Follow-on Trial
`to Assess the
`Long-Term
`Safety and
`Efficacy of Oral
`SPM 927 in
`Subjects With
`Postherpetic
`Neuralgia (PHN)
`
`A Trial to Assess
`the Efficacy and
`Safety of SPM
`927 in Subjects
`With Painful
`Distal Diabetic
`Neuropathy
`
`A Trial to Assess
`the Efficacy and
`Safety of SPM
`927 (Lacosamide)
`in Subjects With
`Painful Distal
`Diabetic
`Neuropathy
`
`Neuropathic
`Pain
`
`Phase SP0745
`
`NCT00235443
`A Follow-On Trial
`2
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00235443?
`to Assess the
`term=NCT00235443&rank=1]
`Long Term Safety
`and Efficacy of
`SPM 927 in
`Painful Distal
`Diabetic
`Neuropathy
`
`Neuropathic
`Pain
`
`Study Evaluating
`Long-term Safety
`and Efficacy of
`Lacosamide in
`Subjects With
`Painful Distal
`Diabetic
`Neuropathy.
`
`Phase SP0746
`
`NCT00546351
`3
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00546351?
`term=NCT00546351&rank=1]
`2004-000551-42
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2004-000551-42]
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT00235443?
`term=NCT00235443&rank=1]
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT00546351?
`term=NCT00546351&rank=1]
`
`[]
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`[]
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`[]
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`[]
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`[]
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`[]
`
`N (
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`E 2
`
`0
`
`http://www.ucb.com/rd/clinical-study-information/vimpat-lacosamide
`
`6/8/2015
`
`00002
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`
`
`Lacosamide (Vimpat®) | UCB
`
`Page 3 of 11
`
`Study
`summary
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`P
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`C 2
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`H 2
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`0
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`H 2
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`0
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`Kr
`20
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`Sh
`20
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`Si
`Pa
`S1
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`C E
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`u
`IA
`Se
`20
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`[]
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`[]
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`[]
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`[]
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`[]
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`[]
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`Disease area
`studied
`
`Epilepsy
`
`Epilepsy
`
`Epilepsy
`
`Epilepsy
`
`Abbreviated title Phase Study ID Registry database
`
`Study results
`
`Phase SP0754
`
`NCT00136019
`3
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00136019?
`term=NCT00136019&rank=1]
`
`
`Phase SP0755
`
`NCT00220415
`3
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00220415?
`term=NCT00220415&rank=1]
`
`
`Phase SP0756
`
`NCT00522275
`3
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00522275?
`term=NCT00522275&rank=1]
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT00522275?
`term=NCT00522275&rank=1]
`
`Phase SP0757
`
`NCT00151879
`3
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00151879?
`term=NCT00151879&rank=1]
`2004-002322-22
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2004-002322-22]
`
`
`SPM 927
`(400mg/Day and
`600mg/Day) as
`Adjunctive
`Therapy in
`Subjects With
`Partial Seizures
`With or Without
`Secondary
`Generalization
`
`A Multicenter,
`Double-blind,
`Randomized,
`Placebo-
`controlled,
`Parallel Group
`Trial to
`Investigate the
`Efficacy and
`Safety of SPM
`927 (200mg/Day
`and 400mg/Day)
`as Adjunctive
`Therapy in
`Subjects With
`Partial Seizures
`With or Without
`Secondary
`Generalization
`
`Determine Safety
`and Efficacy of
`Long-term Oral
`Lacosamide in
`Patients With
`Partial Seizures
`
`Safety and
`Tolerability of
`Intravenous SPM
`927 as
`Replacement for
`Oral SPM 927 in
`Subjects With
`Partial Seizures
`
`Neuropathic
`Pain
`
`Trial to Assess the
`Phase SP0768
`
`NCT00135109
`Efficacy and
`3
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00135109?
`Safety of SPM
`term=NCT00135109&rank=1]
`927 (200, 400,
`and 600mg/Day)
`in Subjects With
`Painful Distal
`Diabetic
`Neuropathy
`
`
`Epilepsy
`
`Assess Safety and
`Efficacy of
`Lacosamide in
`Patients With
`Partial Seizures
`
`Phase SP0774
`
`NCT00515619
`3
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00515619?
`term=NCT00515619&rank=1]
`2004-000152-16
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2004-000152-16]
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT00515619?
`term=NCT00515619&rank=1]
`
`Neuropathic
`Pain
`
`A Trial to Assess
`the Long-term
`Safety and
`Efficacy of
`Lacosamide in
`Subjects With
`Painful Diabetic
`Neuropathy
`
`Phase SP0830
`
`NCT00220337
`3
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00220337?
`term=NCT00220337&rank=1]
`2004-000960-28
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2004-000960-28]
`
`
`Epilepsy
`
`A Multicenter,
`Open-Label
`Study To
`Investigate The
`
`Phase SP0847
`
`NCT00938431
`2
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00938431?
`term=NCT00938431&rank=1]
`2011-001558-27
`
`http://www.ucb.com/rd/clinical-study-information/vimpat-lacosamide
`
`6/8/2015
`
`00003
`
`
`
`Lacosamide (Vimpat®) | UCB
`
`Page 4 of 11
`
`Study
`summary
`
`P
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`[]
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`[]
`
`Bo
`
`N S
`
`2 M N (
`
`A 2
`
`0
`
`Disease area
`studied
`
`Epilepsy
`
`Neuropathic
`Pain
`
`Abbreviated title Phase Study ID Registry database
`
`Study results
`
`Safety And
`Pharmacokinetics
`Of Lacosamide In
`Children With
`Partial Seizures
`
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2011-001558-27]
`
`Phase SP0848
`
`2
`Ongoing
`
`NCT00938912
`[https://clinicaltrials.gov/ct2/show/study/NCT00938912?
`term=NCT00938912&rank=1]
`2011-001559-35
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2011-001559-35]
`
`Phase SP0874
`
`NCT00350103
`3
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00350103?
`term=NCT00350103&rank=1]
`2005-005788-27
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2005-005788-27]
`
`
`An Open-Label
`Study to
`Determine
`Safety ,
`Tolerability, and
`Efficacy of Oral
`Lacosamide in
`Children With
`Epilepsy
`
`A Trial to Assess
`the Efficacy and
`Safety of
`400mg/Day
`Lacosamide in
`Subjects With
`Painful Diabetic
`Neuropathy
`
`D C 1
`
`: 6
`
`4
`th
`So
`3-
`U
`
`W E
`
`p
`–
`
`D C 1
`
`: 6
`
`4
`th
`So
`3-
`U
`
`D C 1
`
`: 6
`
`4
`th
`So
`3-
`U
`
`Phase SP0887
`
`NCT00401830
`2
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00401830?
`term=NCT00401830&rank=1]
`
`Fibromyalgia Assessing
`Efficacy and
`Safety of
`Lacosamide
`Compared to
`Placebo in
`Reducing Signs
`and Symptoms of
`Fibromyalgia
`Syndrome.
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT00401830?
`term=NCT00401830&rank=1]
`
`Phase SP0902
`
`NCT00520741
`3
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00520741?
`term=NCT00520741&rank=1]
`2007-005439-27
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2007-005439-27]
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT00520741?
`term=NCT00520741&rank=1]
`
`Phase SP0904
`
`3
`Ongoing
`
`NCT00530855
`[https://clinicaltrials.gov/ct2/show/study/NCT00530855?
`term=NCT00530855&rank=1]
`2007-005440-25
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2007-005440-25]
`
`Epilepsy
`
`Epilepsy
`
`Trial to
`Demonstrate the
`Efficacy and
`Safety of
`Conversion to
`Lacosamide
`Monotherapy for
`Partial-onset
`Seizures (ALEX-
`MT)
`
`Trial to Assess
`Long-term
`Lacosamide
`(LCM)
`Monotherapy
`Use and Safety of
`LCM
`Monotherapy
`and Adjunctive
`Therapy for
`Partial-onset
`Seizures
`
`Osteoarthritis Trial to Assess
`Efficacy and
`Safety of
`Lacosamide in
`Subjects With
`Osteoarthritis of
`the Knee
`
`Phase SP0905
`
`NCT00485472
`2
`
`Terminated [https://clinicaltrials.gov/ct2/show/study/NCT00485472?
`term=NCT00485472&rank=1]
`2006-005048-97
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2006-005048-97]
`
`Migraine
`disorders
`
`SP0906
`NCT00440518
`Phase
`A Study Designed
`2
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00440518?
`to Test the
`term=NCT00440518&rank=1]
`Effectiveness and
`Safety of Treating
`Patients With
`Lacosamide for
`Migraine
`Prophylaxis
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT00485472?
`term=NCT00485472&rank=1]
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT00440518?
`term=NCT00440518&rank=1]
`
`[]
`
`[]
`
`[]
`
`[]
`
`[]
`
`http://www.ucb.com/rd/clinical-study-information/vimpat-lacosamide
`
`6/8/2015
`
`00004
`
`
`
`Lacosamide (Vimpat®) | UCB
`
`Abbreviated title Phase Study ID Registry database
`
`Study results
`
`Page 5 of 11
`
`Study
`summary
`
`P
`
`Disease area
`studied
`
`Epilepsy
`
`Epilepsy
`
`Epilepsy
`
`Epilepsy
`
`Epilepsy
`
`Epilepsy
`
`Fo
`20
`
`Le
`20
`In
`
`C 2
`
`8
`20
`
`W C 6
`
`6
`th
`So
`30
`20
`
`Ya
`
`C 2
`
`1
`of
`So
`6-
`U
`
`[]
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`[]
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`[]
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`[]
`
`[]
`
`[]
`
`[]
`
`Phase SP0925
`
`NCT00655551
`3
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00655551?
`term=NCT00655551&rank=1]
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT00655551?
`term=NCT00655551&rank=1]
`
`Phase SP0926
`
`NCT00655486
`3
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00655486?
`term=NCT00655486&rank=1]
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT00655486?
`term=NCT00655486&rank=1]
`
`Phase SP0954
`
`NCT00955357
`4
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT00955357?
`term=NCT00955357&rank=1]
`2009-011181-28
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2009-011181-28]
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT00955357?
`term=NCT00955357&rank=1]
`
`Phase SP0961
`
`NCT01118949
`2
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT01118949?
`term=NCT01118949&rank=1]
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT01118949?
`term=NCT01118949&rank=1]
`
`Phase SP0962
`
`NCT01118962
`2
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT01118962?
`term=NCT01118962&rank=1]
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT01118962?
`term=NCT01118962&rank=1]
`
`Phase SP0966
`
`3
`Ongoing
`
`NCT01969851
`[https://clinicaltrials.gov/ct2/show/study/NCT01969851?
`term=NCT01969851&rank=1]
`2012-001446-18
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2012-001446-18]
`
`Safety of
`Intravenous
`Lacosamide
`Dose Followed
`by Twice Daily
`Oral Lacosamide
`in Subjects With
`Partial-onset
`Seizures
`
`Study to Assess
`the Long-term
`Safety of Oral
`Lacosamide in
`Subjects With
`Partial-onset
`Seizures
`
`Trial to Assess
`Lacosamide as
`the First add-on
`Anti-epileptic
`Drug Treatment
`in Patients With
`Partial-onset
`Seizures
`
`Open-Label
`Study to Assess
`Lacosamide
`Safety as Add-on
`Therapy for
`Primary
`Generalized
`Tonic-Clonic
`Seizures in
`Subjects With
`Epilepsy
`
`Open-Label
`Extension Study
`to Assess the
`Safety and
`Seizure
`Frequency
`Associated With
`Lacosamide for
`Primary
`Generalized
`Tonic-Clonic
`Seizures in
`Subjects With
`Idiopathic
`Generalized
`Epilepsy
`
`A Study to
`Investigate the
`Safety and
`Efficacy of
`Lacosamide
`Added to the
`Patients Current
`Therapy in
`Patients Aged 1
`Month to less
`than 18 Years Old
`With Epilepsy
`Syndromes
`Associated With
`Generalized
`Seizures.
`
`Epilepsy
`
`Study to
`Investigate
`Lacosamide as
`
`Phase SP0969
`
`3
`Ongoing
`
`NCT01921205
`[https://clinicaltrials.gov/ct2/show/study/NCT01921205?
`term=NCT01921205&rank=1]
`
`http://www.ucb.com/rd/clinical-study-information/vimpat-lacosamide
`
`6/8/2015
`
`00005
`
`
`
`Lacosamide (Vimpat®) | UCB
`
`Page 6 of 11
`
`Disease area
`studied
`
`Abbreviated title Phase Study ID Registry database
`
`Study results
`
`Study
`summary
`
`P
`
`Epilepsy
`
`Epilepsy
`
`Epilepsy
`
`Epilepsy
`
`Epilepsy
`
`Add-on Therapy
`in Subjects ≥4
`Years to ˂17
`Years of Age With
`Partial Onset
`Seizures
`
`2012-004996-38
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2012-004996-38]
`
`Hormonal and
`Lipid Levels in
`Male Subjects
`After a Switch
`From
`Carbamazepine
`to Lacosamide
`(VICTOR)
`
`eValuation of the
`Efficacy and
`toleRability of
`Vimpat When
`Added to
`lEvetiracetam
`(VERVE)
`
`Phase SP0978
`
`NCT01375374
`3
`
`Terminated [https://clinicaltrials.gov/ct2/show/study/NCT01375374?
`term=NCT01375374&rank=1]
`2010-022534-84
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2010-022534-84]
`
`Phase SP0980
`
`NCT01484977
`3
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT01484977?
`term=NCT01484977&rank=1]
`2011-002461-37
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2011-002461-37]
`
`NCT01243177
`[https://clinicaltrials.gov/ct2/show/study/NCT01243177?
`term=NCT01243177&rank=1]
`2010-019765-28
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2010-019765-28]
`
`NCT01465997
`[https://clinicaltrials.gov/ct2/show/study/NCT01465997?
`term=NCT01465997&rank=1]
`2010-021238-74
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2010-021238-74]
`
`Phase
`SP0993
`3
`Ongoing
`
`Trial Comparing
`the Efficacy and
`Safety of
`Lacosamide
`(LCM) to
`Carbamazepine
`Controlled-
`Release (CBZ-
`CR); Initial
`Monotherapy in
`Epilepsy; Subjects
`Aged 16 and
`Older (SP0993)
`
`Phase SP0994
`
`3
`Ongoing
`
`Evaluating Long
`Term Safety of
`Lacosamide
`(LCM) to
`Carbamazepine
`Controlled-
`release (CBZ-CR);
`Initial
`Monotherapy in
`Epilepsy Subjects
`16 Years and
`Older
`
`Phase SP1007
`
`NCT01235403
`4
`
`Completed [https://clinicaltrials.gov/ct2/show/study/NCT01235403?
`term=NCT01235403&rank=1]
`2010-019268-35
`[https://www.clinicaltrialsregister.eu/ctr-search/search?
`query=2010-019268-35]
`
`Trial to Assess
`Optimized
`Dosage of
`Lacosamide as
`add-on Therapy
`in Patients With
`Partial Onset
`Seizure (SELF)
`
`LINK
`[https://clinicaltrials.gov/ct2/show/results/NCT01235403?
`term=NCT01235403&rank=1]
`
`[]
`
`[]
`
`[]
`
`[]
`
`[]
`
`© 2007 - 2015 UCB S.A., Belgium. All rights reserved
`
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