Clinical Trial Results:
A PROSPECTIVE, MULTINATIONAL, OPEN-LABEL, SINGLE-ARM, EXPLORATIVE STUDY TO EVALUATE THE TOLERABILITY AND EFFICACY OF LACOSAMIDE WHEN ADDED TO LEVETIRACETAM WITH WITHDRAWAL OF THE CONCOMITANT SODIUM CHANNEL BLOCKING ANTIEPILEPTIC DRUG IN SUBJECTS WITH UNCONTROLLED PARTIAL-ONSET SEIZURES
|
Summary
|
|
EudraCT number |
2011-002461-37 |
Trial protocol |
DE SE AT ES NL DK BG HU |
Global end of trial date |
10 Jan 2014
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
30 Jun 2016
|
First version publication date |
09 Jul 2015
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
SP0980
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT01484977 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
UCB BIOSCIENCES Inc
|
||
Sponsor organisation address |
8010 Arco Corporate Drive, Raleigh, United States, 27617
|
||
Public contact |
Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 217348 1515, clinicaltrials@ucb.com
|
||
Scientific contact |
Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 217348 1515, clinicaltrials@ucb.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
10 Mar 2014
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
10 Jan 2014
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
The primary objective of this study is to assess the overall effectiveness of Lacosamide (optimized within the range of 200 mg/day to 600 mg/day) when added to a stable dose of Levetiracetam (in the label range of 1000 mg/day to 3000 mg/day) with withdrawal of the concomitant Sodium Channel Blocking Antiepileptic Drug (SCB-AED) in subjects with partial-onset seizures not adequately controlled on their dual LEV and SCB-AED regimen.
|
||
Protection of trial subjects |
Data privacy measures in place
|
||
Background therapy |
Concomitant AED therapy at baseline with LEV and SCB (CBZ, OXC, PHT, LTG or ESL) | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
01 Dec 2011
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Spain: 12
|
||
Country: Number of subjects enrolled |
Sweden: 3
|
||
Country: Number of subjects enrolled |
Bulgaria: 20
|
||
Country: Number of subjects enrolled |
Denmark: 4
|
||
Country: Number of subjects enrolled |
France: 8
|
||
Country: Number of subjects enrolled |
Germany: 3
|
||
Country: Number of subjects enrolled |
United States: 53
|
||
Country: Number of subjects enrolled |
Romania: 12
|
||
Country: Number of subjects enrolled |
Australia: 5
|
||
Worldwide total number of subjects |
120
|
||
EEA total number of subjects |
62
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
115
|
||
From 65 to 84 years |
5
|
||
85 years and over |
0
|
||
|
|||||||||||||||||||||||||||
|
Recruitment
|
|||||||||||||||||||||||||||
Recruitment details |
The recruitment for the SP0980 study began in December 2011. It concluded in December 2013. This was a multicenter study with subjects enrolled by 30 sites across North America, 12 in Western Europe, 10 in Eastern Europe, and 2 in Oceania. | ||||||||||||||||||||||||||
|
Pre-assignment
|
|||||||||||||||||||||||||||
Screening details |
The SP0980 study enrolled 147 patients. Out of the 147 enrolled patients, there were 27 screen failures. This resulted in 120 eligible patients for this study. | ||||||||||||||||||||||||||
|
Period 1
|
|||||||||||||||||||||||||||
Period 1 title |
Overall Study (overall period)
|
||||||||||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||||||||||
Allocation method |
Not applicable
|
||||||||||||||||||||||||||
Blinding used |
Not blinded | ||||||||||||||||||||||||||
|
Arms
|
|||||||||||||||||||||||||||
|
Arm title
|
Lacosamide | ||||||||||||||||||||||||||
Arm description |
Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED). | ||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||
Investigational medicinal product name |
Lacosamide
|
||||||||||||||||||||||||||
Investigational medicinal product code |
SPM927
|
||||||||||||||||||||||||||
Other name |
VIMPAT®, SPM927, Harkoseride
|
||||||||||||||||||||||||||
Pharmaceutical forms |
Tablet
|
||||||||||||||||||||||||||
Routes of administration |
Oral use
|
||||||||||||||||||||||||||
Dosage and administration details |
50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day.
Maximum duration of study drug administration is approximately 23 weeks.
|
||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Lacosamide
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Lacosamide
|
||
Reporting group description |
Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED). | ||
|
|||||||||
End point title |
Retention at the end of the 21-week Treatment Period [1] | ||||||||
End point description |
Retention is a summary measure that integrates both the patient’s and clinician’s assessment of efficacy and tolerability in epilepsy clinical studies to provide a measure of effectiveness.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Duration of the Treatment Period (21 Weeks)
|
||||||||
| 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: Due to system limitations, a single arm study statistical analysis was not entered. Percentage (retention rate (RR) and its 95 % CI), of subjects remaining in the study through the 21-Week Treatment Period will be calculated. Subjects retained through Week 21 will be counted in the numerator. All subjects in the relevant population will be used as the denominator. n=120 RR (95 % CI): 73.3 (65.42, 81.25). |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Treatment-emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in December 2013.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
9.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Lacosamide
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
18 Oct 2010 |
Protocol Amendment 1, 18 Oct 2011
The protocol was amended in order to revise the age inclusion criterion, which limited enrollment to the adult population (≥18 years).
In addition, a withdrawal criterion was added. The withdrawal criterion clarified that subjects must have been withdrawn from the study if their VNS settings were no longer constant or subject required a change to the VNS Settings. |
||
07 Jun 2013 |
Protocol Amendment 2, 07 Jun 2013
The protocol was amended in order to revise the planned termination of the study. Due to difficulty with enrollment, the initially planned enrollment period was extended approximately 6 months. Despite this extension, it was projected that only approximately 100 total subjects would be enrolled instead of the initially intended subject number of approximately 300. Because of the change in the anticipated number of subjects, the study would not have sufficient power to detect a 50 % reduction in the all-cause discontinuation rate and all analyses would have been exploratory in nature.
In addition, administrative changes were made to update study personnel and 24-hour safety contact information. Revisions were also made to reflect UCB BIOSCIENCES department name change from Global Clinical Safety and Pharmacovigilance (GCSP) to Drug Safety, to clarify wording in Exclusion Criterion #11, and to clarify the temperature log recording requirements. Minor typographical revisions were also made. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
