Clinical trial NCT02582866: A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Lacosamide
Vimpat
Epilepsy
Partial onset seizures
Tonic-clonic seizures
Monotherapy
AED
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2015-10-21
Enrollment: 106
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
timeFrame: From Visit 1 (Week 0) to Final Visit (up to Week 158)
measure: Percentage of Participants That Withdrew Due to Adverse Events (AEs)
timeFrame: From Visit 1 (Week 0) to Final Visit (up to Week 158)
measure: Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
timeFrame: From Visit 1 (Week 0) to Final Visit (up to Week 158)
Secondary outcomes:
Other outcomes:
Locations:
city: Blagoevgrad
country: Bulgaria
facility: Sp1042 805
city: Pazardzhik
country: Bulgaria
facility: Sp1042 807
city: Sofia
country: Bulgaria
facility: Sp1042 811
city: Helsinki
country: Finland
facility: Sp1042 205
city: Kuopio
country: Finland
facility: Sp1042 207
city: Nancy
country: France
facility: Sp1042 236
city: Altenburg
country: Germany
facility: Sp1042 263
city: Bad Neustadt An Der Saale
country: Germany
facility: Sp1042 265
city: Leipzig
country: Germany
facility: Sp1042 269
city: Marburg
country: Germany
facility: Sp1042 256
city: Osnabruck
country: Germany
facility: Sp1042 259
city: Asaka
country: Japan
facility: Sp1042 831
city: Kagoshima
country: Japan
facility: Sp1042 834
city: Kamakura
country: Japan
facility: Sp1042 844
city: Nagoyashi
country: Japan
facility: Sp1042 835
city: Okayama
country: Japan
facility: Sp1042 837
city: Sapporo
country: Japan
facility: Sp1042 847
city: Daegu
country: Korea, Republic of
facility: Sp1042 521
city: Daejeon
country: Korea, Republic of
facility: Sp1042 518
city: Seoul
country: Korea, Republic of
facility: Sp1042 517
city: Seoul
country: Korea, Republic of
facility: Sp1042 519
city: Riga
country: Latvia
facility: Sp1042 751
city: San Luis Potosi
country: Mexico
facility: Sp1042 547
city: Pasig
country: Philippines
facility: Sp1042 672
city: Quezon
country: Philippines
facility: Sp1042 676
city: Katowice
country: Poland
facility: Sp1042 340
city: Lublin
country: Poland
facility: Sp1042 342
city: Warszawa
country: Poland
facility: Sp1042 343
city: Bucuresti
country: Romania
facility: Sp1042 576
city: Iasi
country: Romania
facility: Sp1042 570
city: Targu Mures
country: Romania
facility: Sp1042 572
city: Kazan
country: Russian Federation
facility: Sp1042 387
city: Kazan
country: Russian Federation
facility: Sp1042 389
city: Moscow
country: Russian Federation
facility: Sp1042 401
city: Novosibirsk
country: Russian Federation
facility: Sp1042 392
city: Saint Petersburg
country: Russian Federation
facility: Sp1042 397
city: Saint Petersburg
country: Russian Federation
facility: Sp1042 400
city: Goteborg
country: Sweden
facility: Sp1042 440
city: Linköping
country: Sweden
facility: Sp1042 442
city: Stockholm
country: Sweden
facility: Sp1042 438
city: Aarau
country: Switzerland
facility: Sp1042 651
city: Biel
country: Switzerland
facility: Sp1042 654
city: Lugano
country: Switzerland
facility: Sp1042 653
city: Chernihiv
country: Ukraine
facility: Sp1042 622
city: Kharkov
country: Ukraine
facility: Sp1042 626
city: Odesa
country: Ukraine
facility: Sp1042 625
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.