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History of Changes for Study: NCT01964560
Long-term Extension Study to Investigate Lacosamide as an Add-on Therapy in Children With Partial Onset Seizures
Latest version (submitted July 21, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 14, 2013 None (earliest Version on record)
2 October 31, 2013 Study Status
3 December 19, 2013 Study Status
4 January 23, 2014 Study Status
5 February 28, 2014 Recruitment Status, Study Status, Contacts/Locations and Oversight
6 April 25, 2014 Study Status
7 June 25, 2014 Study Status
8 August 28, 2014 Study Status and Contacts/Locations
9 September 23, 2014 Study Status and Contacts/Locations
10 October 16, 2014 Study Status and Contacts/Locations
11 November 20, 2014 Study Status and Contacts/Locations
12 December 16, 2014 Study Status and Contacts/Locations
13 January 27, 2015 Study Status and Contacts/Locations
14 February 27, 2015 Study Status and Contacts/Locations
15 March 31, 2015 Study Status and Contacts/Locations
16 April 30, 2015 Study Status and Contacts/Locations
17 May 27, 2015 Study Status and Contacts/Locations
18 June 30, 2015 Study Status and Contacts/Locations
19 July 31, 2015 Study Status and Contacts/Locations
20 August 31, 2015 Study Status and Contacts/Locations
21 September 11, 2015 Eligibility, Arms and Interventions, Sponsor/Collaborators, Outcome Measures and Study Status
22 October 2, 2015 Study Status and Contacts/Locations
23 November 2, 2015 Study Status and Contacts/Locations
24 December 2, 2015 Study Status and Contacts/Locations
25 December 10, 2015 Study Design and Study Status
26 January 8, 2016 Study Status and Contacts/Locations
27 February 3, 2016 Study Status and Contacts/Locations
28 March 1, 2016 Study Status and Contacts/Locations
29 March 18, 2016 Contacts/Locations and Study Status
30 April 18, 2016 Contacts/Locations and Study Status
31 April 22, 2016 Contacts/Locations and Study Status
32 May 17, 2016 Study Status and Contacts/Locations
33 June 16, 2016 Study Status and Contacts/Locations
34 July 13, 2016 Contacts/Locations and Study Status
35 August 2, 2016 Study Status and Contacts/Locations
36 August 30, 2016 Contacts/Locations and Study Status
37 September 5, 2016 Study Status and Contacts/Locations
38 October 7, 2016 Study Status and Contacts/Locations
39 October 20, 2016 Contacts/Locations and Study Status
40 November 16, 2016 Study Status and Contacts/Locations
41 January 3, 2017 Study Status and Contacts/Locations
42 January 9, 2017 Contacts/Locations and Study Status
43 March 2, 2017 Study Status and Contacts/Locations
44 March 30, 2017 Contacts/Locations and Study Status
45 April 26, 2017 Contacts/Locations and Study Status
46 May 4, 2017 Study Status
47 May 24, 2017 Contacts/Locations and Study Status
48 August 3, 2017 Study Status and Contacts/Locations
49 September 27, 2017 Study Status and Contacts/Locations
50 October 26, 2017 Study Status and Contacts/Locations
51 November 23, 2017 Study Status
52 January 23, 2018 Study Status and Contacts/Locations
53 February 15, 2018 Study Status
54 March 13, 2018 Study Status
55 April 11, 2018 Contacts/Locations and Study Status
56 May 14, 2018 Contacts/Locations and Study Status
57 June 7, 2018 Study Status
58 June 21, 2018 Study Status
59 August 2, 2018 Contacts/Locations and Study Status
60 October 24, 2018 Study Status
61 November 8, 2018 Study Status and Contacts/Locations
62 November 22, 2018 Contacts/Locations and Study Status
63 November 26, 2018 Contacts/Locations and Study Status
64 December 19, 2018 Study Status and Contacts/Locations
65 March 18, 2019 Study Status and Contacts/Locations
66 September 16, 2019 Study Status and Contacts/Locations
67 October 7, 2019 Study Status and Contacts/Locations
68 October 27, 2019 Contacts/Locations and Study Status
69 November 29, 2019 Study Status and Contacts/Locations
70 June 22, 2020 Contacts/Locations and Study Status
71 June 23, 2020 Recruitment Status, Study Status and Study Design
72 June 25, 2020 Study Status
73 July 16, 2020 Contacts/Locations and Study Status
74 July 29, 2020 Study Status
75 August 13, 2020 Study Status and Contacts/Locations
76 November 5, 2020 Study Status
77 December 31, 2020 Study Status
78 January 28, 2021 Study Status
79 February 25, 2021 Study Status
80 May 6, 2021 Study Status
81 June 3, 2021 Study Status
82 July 29, 2021 Outcome Measures, Study Description, Oversight, Sponsor/Collaborators, Study Status, IPDSharing, Contacts/Locations, Eligibility, Conditions and Study Identification
83 August 11, 2021 Study Status
84 January 3, 2022 Study Status
85 March 10, 2022 Study Status and Contacts/Locations
86 March 24, 2022 Contacts/Locations and Study Status
87 March 28, 2022 Contacts/Locations and Study Status
88 April 7, 2022 Study Status
89 June 13, 2022 Recruitment Status, Study Status, Oversight and Contacts/Locations
90 July 21, 2022 Contacts/Locations, Study Status and Outcome Measures
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Study NCT01964560
Submitted Date:  October 14, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: EP0034
Brief Title: Long-term Extension Study to Investigate Lacosamide as an Add-on Therapy in Children With Partial Onset Seizures
Official Title: A Multicenter, Open-label, Long-term Extension Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Pediatric Subjects With Epilepsy With Partial-Onset Seizures
Secondary IDs: 2012-005012-26 [EudraCT Number]
Open or close this module Study Status
Record Verification: October 2013
Overall Status: Not yet recruiting
Study Start: March 2014
Primary Completion: January 2019 [Anticipated]
Study Completion: January 2019 [Anticipated]
First Submitted: October 14, 2013
First Submitted that
Met QC Criteria:
October 14, 2013
First Posted: October 17, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 14, 2013
Last Update Posted: October 17, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: UCB Pharma
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Study to evaluate the long-term safety and tolerability of Lacosamide (LCM) administered in addition to 1 to ≤3 other Anti-Epileptic Drugs in subjects with epilepsy ≥1 month to ≤18 years who currently have uncontrolled partial onset seizures.
Detailed Description:

The primary objective of this study is to evaluate the long-term safety and tolerability of LCM administered concomitantly with 1 to ≤3 Anti-Epileptic Drugs (AEDs) in subjects with epilepsy ≥1 month to ≤18 years of age who currently have uncontrolled partial onset seizures.

The secondary objective is to evaluate the efficacy during long-term exposure to LCM in subjects epilepsy ≥1 month to ≤18 years of age.

An additional objective is to assess behavior, cognition, quality of life, and development during long-term LCM exposure in pediatric subjects

Open or close this module Conditions
Conditions: Epilepsy
Keywords: Lacosamide
Vimpat
UCB
Epilepsy
Partial Onset Seizures
Pediatric
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 500 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Lacosamide Drug: Lacosamide

Subjects <30 kg (LCM oral solution) 1 mg/ kg - 6 mg/ kg BID (2 mg/kg/ day - 12 mg/ kg/ day)

Subjects ≥50 kg (LCM tablets): 50 mg - 300 mg BID (100 mg/ day - 600 mg/ day)

Other Names:
  • VIMPAT
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) during the study
[ Time Frame: Baseline to the End of Treatment (approximately 96 weeks) ]

2. Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) leading to discontinuation from the study
[ Time Frame: Baseline to End of Treatment (approximately 96 weeks) ]

Secondary Outcome Measures:
1. Percentage of Seizure Free Days at the End of Year 1
[ Time Frame: End of Year 1 of the Study (approximately 52 weeks) ]

2. Percentage of Seizure Free Days at the End of Year 2
[ Time Frame: End of Year 2 of the Study (approximately 96 weeks) ]

Open or close this module Eligibility
Minimum Age: 1 Month
Maximum Age: 18 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
  • Subject has completed the Transition Period of SP0967 or SP0969 (NCT01921205) for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy
  • Subject is expected to benefit from participation, in the opinion of the investigator
  • Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator

Exclusion Criteria:

  • Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM)
  • Subject is experiencing an ongoing Serious Adverse Event (SAE)
  • For subjects ≥6 years of age, subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1
  • Subjects with a major protocol deviation during the primary study (or a deviation related to enrollment criteria for primary study).
  • Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception
Open or close this module Contacts/Locations
Central Contact Person: UCB Clinical Trial Call Center
Telephone: +1 877 822 9493
Study Officials: UCB Clinical Trial Call Center
Study Director
+1 877 822 9493
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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