Clinical Trial Results:
An open-label extension study to assess the safety and seizure frequency associated with long-term oral lacosamide for uncontrolled primary generalized
tonic-clonic seizures in subjects with idiopathic generalized epilepsy
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Summary
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EudraCT number |
2014-004375-23 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
25 Oct 2012
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Jun 2016
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First version publication date |
04 Jul 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
SP0962
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01118962 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
UCB BIOSCIENCES, Inc
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Sponsor organisation address |
8010 Arco Corporate Drive, Raleigh, United States, 27617
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Public contact |
Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 15, clinicaltrials@ucb.com
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Scientific contact |
Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 15, clinicaltrials@ucb.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
11 Dec 2012
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
25 Oct 2012
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The objectives of this study were:
- To obtain data on the safety and seizure frequency associated with long-term oral Lacosamide (LCM) for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized epilepsy (IGE)
- To allow subjects who completed SP0961 to continue to receive LCM
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Protection of trial subjects |
There were no specific protocol measures in place to protect subjects.
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Background therapy |
Not applicable | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
18 Aug 2010
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety | ||
Long term follow-up duration |
14 Months | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 39
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Worldwide total number of subjects |
39
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
3
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Adults (18-64 years) |
36
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
This study began enrollment in August 2010. The study completed in October 2012. The participant flow consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM). | ||||||||||||||||||||||
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Pre-assignment
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Screening details |
The participant flow refers to the Safety Set, which consists of all subjects that were dosed at least once with Lacosamide (LCM). | ||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||
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Arms
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Arm title
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Lacosamide | ||||||||||||||||||||||
Arm description |
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses. | ||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||
Investigational medicinal product name |
Lacosamide
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Investigational medicinal product code |
Lacosamide LCM
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Other name |
Vimpat
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).
Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
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Baseline characteristics reporting groups
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Reporting group title |
Lacosamide
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Reporting group description |
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Lacosamide
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Reporting group description |
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses. | ||
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End point title |
Number of participants with Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (approximately 61 weeks) [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
From Visit 1 to the end of study (Approximately 61 weeks)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of participants withdrawn from the study due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (approximately 61 weeks) [2] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
From Visit 1 to the end of study (Approximately 61 weeks)
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Adverse Events were collected from August 2010 through October 2012.
Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
9.1
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Reporting groups
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Reporting group title |
Lacosamide
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Reporting group description |
Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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02 Nov 2010 |
Protocol Amendment 1, dated 02 Nov 2010, provided for the following changes:
- To remove the variable of percent change in PGTC seizure frequency per 28 days from Baseline
- To revise withdrawal criteria and follow-up recommendations for abnormal liver function tests (LFTs)
- To increase the number of study sites from 10 to 25
- To remove the 150mg and 200mg LCM doses of study medication
- Minor administrative changes
Based on the date of the amendment, 1 subject was enrolled in the study prior to this amendment (Table 1.3.1). |
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24 Aug 2011 |
Protocol Amendment 2, dated 24 Aug 2011, provided for the following changes:
- To add the Columbia-Suicide Severity Rating Scale (C-SSRS) and accompanying necessary revisions
- To add the list of anticipated serious adverse events (SAEs)
- To change the Sponsor’s name to UCB BIOSCIENCES Inc
- Minor administrative changes
Based on the date of the amendment, an additional 37 subjects were enrolled in the study prior to this amendment (Table 1.3.1). |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
