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A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lacosamide
Sponsored by
UCB Biopharma S.P.R.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Lacosamide, Vimpat, Epilepsy, Partial onset seizures, Tonic-clonic seizures, Monotherapy, AED

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sp1042 805
  • Sp1042 807
  • Sp1042 811
  • Sp1042 205
  • Sp1042 207
  • Sp1042 236
  • Sp1042 263
  • Sp1042 265
  • Sp1042 269
  • Sp1042 256
  • Sp1042 259
  • Sp1042 831
  • Sp1042 834
  • Sp1042 844
  • Sp1042 835
  • Sp1042 837
  • Sp1042 847
  • Sp1042 521
  • Sp1042 518
  • Sp1042 517
  • Sp1042 519
  • Sp1042 751
  • Sp1042 547
  • Sp1042 672
  • Sp1042 676
  • Sp1042 340
  • Sp1042 342
  • Sp1042 343
  • Sp1042 576
  • Sp1042 570
  • Sp1042 572
  • Sp1042 387
  • Sp1042 389
  • Sp1042 401
  • Sp1042 392
  • Sp1042 397
  • Sp1042 400
  • Sp1042 440
  • Sp1042 442
  • Sp1042 438
  • Sp1042 651
  • Sp1042 654
  • Sp1042 653
  • Sp1042 622
  • Sp1042 626
  • Sp1042 625

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lacosamide

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Percentage of Participants That Withdrew Due to Adverse Events (AEs)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect Is an infection that requires treatment parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardize the study participants, or may require medical or surgical intervention to prevent any of the above.

Secondary Outcome Measures

Full Information

First Posted
October 20, 2015
Last Updated
May 10, 2023
Sponsor
UCB Biopharma S.P.R.L.
Collaborators
Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT02582866
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma S.P.R.L.
Collaborators
Parexel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Lacosamide, Vimpat, Epilepsy, Partial onset seizures, Tonic-clonic seizures, Monotherapy, AED

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
Vimpat, SPM927, LCM
Intervention Description
Pharmaceutical Form: Oral tablets Concentration: 50 mg Route of Administration: Oral administration
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
Description
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Time Frame
From Visit 1 (Week 0) to Final Visit (up to Week 158)
Title
Percentage of Participants That Withdrew Due to Adverse Events (AEs)
Description
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Time Frame
From Visit 1 (Week 0) to Final Visit (up to Week 158)
Title
Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
Description
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect Is an infection that requires treatment parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardize the study participants, or may require medical or surgical intervention to prevent any of the above.
Time Frame
From Visit 1 (Week 0) to Final Visit (up to Week 158)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Sp1042 805
City
Blagoevgrad
Country
Bulgaria
Facility Name
Sp1042 807
City
Pazardzhik
Country
Bulgaria
Facility Name
Sp1042 811
City
Sofia
Country
Bulgaria
Facility Name
Sp1042 205
City
Helsinki
Country
Finland
Facility Name
Sp1042 207
City
Kuopio
Country
Finland
Facility Name
Sp1042 236
City
Nancy
Country
France
Facility Name
Sp1042 263
City
Altenburg
Country
Germany
Facility Name
Sp1042 265
City
Bad Neustadt An Der Saale
Country
Germany
Facility Name
Sp1042 269
City
Leipzig
Country
Germany
Facility Name
Sp1042 256
City
Marburg
Country
Germany
Facility Name
Sp1042 259
City
Osnabruck
Country
Germany
Facility Name
Sp1042 831
City
Asaka
Country
Japan
Facility Name
Sp1042 834
City
Kagoshima
Country
Japan
Facility Name
Sp1042 844
City
Kamakura
Country
Japan
Facility Name
Sp1042 835
City
Nagoyashi
Country
Japan
Facility Name
Sp1042 837
City
Okayama
Country
Japan
Facility Name
Sp1042 847
City
Sapporo
Country
Japan
Facility Name
Sp1042 521
City
Daegu
Country
Korea, Republic of
Facility Name
Sp1042 518
City
Daejeon
Country
Korea, Republic of
Facility Name
Sp1042 517
City
Seoul
Country
Korea, Republic of
Facility Name
Sp1042 519
City
Seoul
Country
Korea, Republic of
Facility Name
Sp1042 751
City
Riga
Country
Latvia
Facility Name
Sp1042 547
City
San Luis Potosi
Country
Mexico
Facility Name
Sp1042 672
City
Pasig
Country
Philippines
Facility Name
Sp1042 676
City
Quezon
Country
Philippines
Facility Name
Sp1042 340
City
Katowice
Country
Poland
Facility Name
Sp1042 342
City
Lublin
Country
Poland
Facility Name
Sp1042 343
City
Warszawa
Country
Poland
Facility Name
Sp1042 576
City
Bucuresti
Country
Romania
Facility Name
Sp1042 570
City
Iasi
Country
Romania
Facility Name
Sp1042 572
City
Targu Mures
Country
Romania
Facility Name
Sp1042 387
City
Kazan
Country
Russian Federation
Facility Name
Sp1042 389
City
Kazan
Country
Russian Federation
Facility Name
Sp1042 401
City
Moscow
Country
Russian Federation
Facility Name
Sp1042 392
City
Novosibirsk
Country
Russian Federation
Facility Name
Sp1042 397
City
Saint Petersburg
Country
Russian Federation
Facility Name
Sp1042 400
City
Saint Petersburg
Country
Russian Federation
Facility Name
Sp1042 440
City
Goteborg
Country
Sweden
Facility Name
Sp1042 442
City
Linköping
Country
Sweden
Facility Name
Sp1042 438
City
Stockholm
Country
Sweden
Facility Name
Sp1042 651
City
Aarau
Country
Switzerland
Facility Name
Sp1042 654
City
Biel
Country
Switzerland
Facility Name
Sp1042 653
City
Lugano
Country
Switzerland
Facility Name
Sp1042 622
City
Chernihiv
Country
Ukraine
Facility Name
Sp1042 626
City
Kharkov
Country
Ukraine
Facility Name
Sp1042 625
City
Odesa
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
34265173
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.
Results Reference
result
PubMed Identifier
34246118
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.
Results Reference
result
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994

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