Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures
VALUE
An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy
2 other identifiers
interventional
239
21 countries
87
Brief Summary
Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures (PGTCS) in subjects \>= 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 \[NCT02408523\] study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2015
Longer than P75 for phase_3
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2015
CompletedFirst Posted
Study publicly available on registry
April 3, 2015
CompletedStudy Start
First participant enrolled
August 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedResults Posted
Study results publicly available
December 14, 2023
CompletedDecember 14, 2023
November 1, 2023
7.7 years
March 31, 2015
September 28, 2023
November 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
Number of Study Participants With Treatment-emergent Adverse Events (TEAEs) Over the Duration of the Treatment Period
AEs were considered treatment-emergent if event had onset on or after date of first study medication dose in EP0012 and within 30 days following last study medication dose or events whose intensity worsened on or after date of first study medication dose and within 30 days following date of last study medication administration. Adverse Events were reported spontaneously by the participant and/or caregiver or observed by the investigator.
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Number of Study Participants Withdrawn Due to TEAEs
AEs were considered treatment-emergent if event had onset on or after date of first study medication dose in EP0012 and within 30 days following last study medication dose or events whose intensity worsened on or after date of first study medication dose and within 30 days following date of last study medication administration. Adverse Events were reported spontaneously by the participant and/or caregiver or observed by the investigator.
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Number of Study Participants With New Appearance of Absence and/or Myoclonic Seizures During the Treatment Period
The number of study participants with appearance of new absence and/or myoclonic seizure types experienced during the Treatment Period but who did not experience in Combined Baseline Period or in seizure classification history, before taking LCM were reported. To determine appearance of new seizure type, the Combined Baseline Period was used. Thus, the participants who directly enrolled into EP0012, the Baseline absence, and/or myoclonic seizure data from SP0982's 4-week Prospective Baseline Period were combined with any reported Baseline absence, and myoclonic seizure information in the daily seizure diary from EP0012 (reported before first dose in EP0012) to recalculate the study participant's Baseline variables such as days with absence, and/or myoclonic seizures per 28 days.
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Number of Study Participants With an Increase of up to 25% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
The number of participants experiencing an increase of up to 25% in the number of days with absence seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with absence seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Number of Study Participants With an Increase of Greater Than (>)25% to 50% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
The number of participants experiencing an increase of \>25% to 50% in the number of days with absence seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with absence seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Number of Study Participants With an Increase of >50% to 75% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
The number of participants experiencing an increase of \>50% to 75% in the number of days with absence seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with absence seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Number of Study Participants With an Increase of >75% in Days With Absence Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
The number of participants experiencing an increase of \>75% in the number of days with absence seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with absence seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Number of Study Participants With an Increase of up to 25% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
The number of participants experiencing an increase of up to 25% in the number of days with myoclonic seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with myoclonic seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Number of Study Participants With an Increase of >25% to 50% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
The number of participants experiencing an increase of \>25% to 50% in the number of days with myoclonic seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with myoclonic seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Number of Study Participants With an Increase of >50% to 75% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
The number of participants experiencing an increase of \>50% to 75% in the number of days with myoclonic seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with myoclonic seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Number of Study Participants With an Increase of >75% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
The number of participants experiencing an increase of \>75% in the number of days with myoclonic seizures per 28 days during the Treatment Period compared to the Prospective Baseline Period (for those participants with myoclonic seizure data reported in the 4-week Prospective Baseline Period in SP0982) were reported. This period started on the day of Visit 1 of SP0982 and ended the day before Visit 2 of SP0982. For the direct enrollers into EP0012, Prospective Baseline ended the day before Visit 1 (or prior to first dose) of EP0012.
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years), compared to the Prospective SP0982 Baseline Period
Percentage of Study Participants With at Least 50% Worsening in Days With Absence Seizures
Seizure worsening was defined as a participant experiencing \>=50% increase in the number of days with absence seizures per 28 days from Prospective Baseline. Percentages for seizure worsening were based on those participants who have reported a history of or an occurrence of absence seizures in Prospective Baseline or the Treatment Period.
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Percentage of Study Participants With at Least 50% Worsening in Days With Myoclonic Seizures
Seizure worsening was defined as a participant experiencing \>=50% increase in the number of days with myoclonic seizures per 28 days from Prospective Baseline. Percentages for seizure worsening were based on those participants who have reported a history of or an occurrence of myoclonic seizures in Prospective Baseline or the Treatment Period.
From Visit 1 (Week 0) to End of Treatment Period (up to approximately 5 years)
Secondary Outcomes (36)
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hemoglobin)
During the study (up to approximately 5 years)
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Hematocrit)
During the study (up to approximately 5 years)
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Platelets)
During the study (up to approximately 5 years)
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Erythrocytes)
During the study (up to approximately 5 years)
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in Hematology Parameters (Leukocytes)
During the study (up to approximately 5 years)
- +31 more secondary outcomes
Study Arms (1)
Lacosamide
EXPERIMENTALStart dose SP0982 completers at V1: * LCM 10 mg/kg/day for pediatric subjects weighing \<30 kg * LCM 8 mg/kg/day for pediatric subjects weighing ≥ 30kg to \<50 kg * LCM 400 mg/day (200 mg bid) for adult subjects (≥18 years of age) or pediatric subjects weighing ≥50 kg SP0982 Baseline failures at V1: * LCM 2 mg/kg/day for pediatric subjects weighing \<50 kg * LCM 100 mg/day (50 mg bid) for adult subjects (≥18 years of age) or pediatric subjects weighing ≥50 kg Oral solution (pediatric subjects \<50 kg): * Minimum LCM dose: 4 mg/kg/day * Maximum LCM dose: 12 mg/kg/day Tablets (pediatric subjects ≥50kg): * Minimum LCM dose: 200 mg/day * Minimum LCM dose: 600 mg/day Tablets (adult subjects): * Minimum LCM dose: 200 mg/day * Maximum LCM dose: 800 mg/day
Interventions
* Active substance: Lacosamide * Pharmaceutical form: Tablet * Concentration: 50 mg and 100 mg * Route of Administration: Oral administration
* Active substance: Lacosamide * Pharmaceutical form: Oral solution * Concentration: 10 mg/ml * Route of Administration: Oral administration
Eligibility Criteria
You may qualify if:
- \- Subject must have completed or be an eligible Baseline failure from the parent study (SP0982 \[NCT02408523\]). Note: Other subjects screened for SP0982 may be considered for roll-over to EP0012 if the investigator considers that the subject could benefit from treatment with open-label lacosamide (LCM) and based on prior discussion with and approval from the UCB Study Physician or representative
You may not qualify if:
- Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
- Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE)
- Subject has an active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (87)
EP0012 5
Little Rock, Arkansas, 72205, United States
EP0012 8
Santa Monica, California, 90404, United States
Ep0012 31
Colorado Springs, Colorado, 80907, United States
Ep0012 42
Loxahatchee Groves, Florida, 33470, United States
Ep0012 13
Panama City, Florida, 32405, United States
EP0012 2
Port Charlotte, Florida, 33952, United States
Ep0012 15
Boise, Idaho, 83702, United States
Ep0012 21
Peoria, Illinois, 61637, United States
Ep0012 25
Golden Valley, Minnesota, 55422, United States
Ep0012 43
New York, New York, 10016, United States
Ep0012 53
Austin, Texas, 78758, United States
Ep0012 50
Greenville, Texas, 75401, United States
Ep0012 34
Houston, Texas, 77005, United States
Ep0012 38
San Antonio, Texas, 78229, United States
Ep0012 27
Renton, Washington, 98057, United States
Ep0012 23
Madison, Wisconsin, 53715, United States
Ep0012 980
Chatswood, Australia
Ep0012 985
Heidelberg, Australia
Ep0012 986
Melbourne, Australia
Ep0012 981
Parkville, Australia
Ep0012 181
Curitiba, Brazil
Ep0012 180
Florianópolis, Brazil
Ep0012 186
Passo Fundo, Brazil
Ep0012 185
Porto Alegre, Brazil
Ep0012 188
Rio de Janeiro, Brazil
Ep0012 183
São Paulo, Brazil
Ep0012 500
Blagoevgrad, Bulgaria
Ep0012 501
Sofia, Bulgaria
Ep0012 971
Beijing, China
Ep0012 976
Changchun, China
Ep0012 972
Shanghai, China
Ep0012 550
Ostrava- Poruba, Czechia
Ep0012 553
Prague, Czechia
Ep0012 556
Prague, Czechia
Ep0012 552
Zlín, Czechia
Ep0012 255
Bron, France
Ep0012 252
Lille, France
Ep0012 251
Nancy, France
Ep0012 303
Erlangen, Germany
Ep0012 314
Freiburg im Breisgau, Germany
Ep0012 311
Marburg, Germany
Ep0012 600
Budapest, Hungary
Ep0012 603
Szeged, Hungary
Ep0012 850
Rehovot, Israel
Ep0012 851
Tel Litwinsky, Israel
Ep0012 351
Torino, Italy
Ep0012 906
Fukuoka, Japan
Ep0012 910
Gifu, Japan
Ep0012 903
Hamamatsu, Japan
Ep0012 902
Hiroshima, Japan
Ep0012 912
Kagoshima, Japan
Ep0012 914
Kodaira, Japan
Ep0012 909
Kokubunji-shi, Japan
Ep0012 901
Niigata, Japan
Ep0012 911
Omura-shi, Japan
Ep0012 900
Sapporo, Japan
Ep0012 908
Shinjuku-ku, Japan
Ep0012 161
Guadalajara, Mexico
Ep0012 657
Częstochowa, Poland
Ep0012 655
Gdansk, Poland
Ep0012 652
Gliwice, Poland
Ep0012 651
Katowice, Poland
Ep0012 653
Katowice, Poland
Ep0012 654
Katowice, Poland
Ep0012 656
Tyniec Mały, Poland
Ep0012 650
Warsaw, Poland
Ep0012 659
Warsaw, Poland
Ep0012 451
Lisbon, Portugal
Ep0012 704
Iași, Romania
Ep0012 700
Timișoara, Romania
Ep0012 750
Kazan', Russia
Ep0012 758
Pyatigorsk, Russia
Ep0012 755
Saint Petersburg, Russia
Ep0012 756
Saint Petersburg, Russia
Ep0012 752
Samara, Russia
Ep0012 757
Yekaterinburg, Russia
Ep0012 821
Bardejov, Slovakia
Ep0012 823
Hlohovec, Slovakia
Ep0012 940
Daegu, South Korea
Ep0012 941
Seoul, South Korea
Ep0012 944
Seoul, South Korea
Ep0012 402
Barcelona, Spain
Ep0012 406
Córdoba, Spain
Ep0012 407
Madrid, Spain
Ep0012 403
Seville, Spain
Ep0012 961
Taichung, Taiwan
Ep0012 960
Taipei, Taiwan
Related Publications (1)
Vossler DG, Farkas MK, Poverennova I, Watanabe M, Conrath P, Dimova S, McClung C, Roebling R, Williams P, O'Brien TJ; EP0012 Study Group. Long-term safety and efficacy of adjunctive lacosamide in the treatment of generalized onset tonic-clonic seizures: An open-label extension trial. Epilepsia. 2024 Dec;65(12):3488-3500. doi: 10.1111/epi.18158. Epub 2024 Oct 26.
PMID: 39460685DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
March 31, 2015
First Posted
April 3, 2015
Study Start
August 3, 2015
Primary Completion
March 30, 2023
Study Completion
March 30, 2023
Last Updated
December 14, 2023
Results First Posted
December 14, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.