A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
NCT ID: NCT02582866
Last Updated: 2023-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
106 participants
INTERVENTIONAL
2016-01-31
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lacosamide
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.
Lacosamide
* Pharmaceutical Form: Oral tablets
* Concentration: 50 mg
* Route of Administration: Oral administration
Interventions
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Lacosamide
* Pharmaceutical Form: Oral tablets
* Concentration: 50 mg
* Route of Administration: Oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
17 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
UCB Biopharma S.P.R.L.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273 (UCB)
Locations
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Sp1042 805
Blagoevgrad, , Bulgaria
Sp1042 807
Pazardzhik, , Bulgaria
Sp1042 811
Sofia, , Bulgaria
Sp1042 205
Helsinki, , Finland
Sp1042 207
Kuopio, , Finland
Sp1042 236
Nancy, , France
Sp1042 263
Altenburg, , Germany
Sp1042 265
Bad Neustadt an der Saale, , Germany
Sp1042 269
Leipzig, , Germany
Sp1042 256
Marburg, , Germany
Sp1042 259
Osnabrück, , Germany
Sp1042 831
Asaka, , Japan
Sp1042 834
Kagoshima, , Japan
Sp1042 844
Kamakura, , Japan
Sp1042 835
Nagoya, , Japan
Sp1042 837
Okayama, , Japan
Sp1042 847
Sapporo, , Japan
Sp1042 751
Riga, , Latvia
Sp1042 547
San Luis Potosí City, , Mexico
Sp1042 672
Pasig, , Philippines
Sp1042 676
Quezon, , Philippines
Sp1042 340
Katowice, , Poland
Sp1042 342
Lublin, , Poland
Sp1042 343
Warsaw, , Poland
Sp1042 576
Bucharest, , Romania
Sp1042 570
Iași, , Romania
Sp1042 572
Târgu Mureş, , Romania
Sp1042 387
Kazan', , Russia
Sp1042 389
Kazan', , Russia
Sp1042 401
Moscow, , Russia
Sp1042 392
Novosibirsk, , Russia
Sp1042 397
Saint Petersburg, , Russia
Sp1042 400
Saint Petersburg, , Russia
Sp1042 521
Daegu, , South Korea
Sp1042 518
Daejeon, , South Korea
Sp1042 517
Seoul, , South Korea
Sp1042 519
Seoul, , South Korea
Sp1042 440
Gothenburg, , Sweden
Sp1042 442
Linköping, , Sweden
Sp1042 438
Stockholm, , Sweden
Sp1042 651
Aarau, , Switzerland
Sp1042 654
Biel, , Switzerland
Sp1042 653
Lugano, , Switzerland
Sp1042 622
Chernihiv, , Ukraine
Sp1042 626
Kharkiv, , Ukraine
Sp1042 625
Odesa, , Ukraine
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2015-001549-96
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP1042
Identifier Type: -
Identifier Source: org_study_id
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