Clinical Trial Results:
A multicenter, open-label study to investigate the pharmacokinetics of commercial lacosamide oral formulation as therapy in children (aged 1 month to 17 years) with epilepsy.
Summary
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EudraCT number |
2014-002629-36 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
29 Jul 2014
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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 |
11 Feb 2015
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Other versions |
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 |
SP1047
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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, 0049 2173 48 15 15, clinicaltrials@ucb.com
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Scientific contact |
Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 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) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000402-PIP02-11 | ||
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 |
24 Oct 2014
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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 |
29 Jul 2014
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The objective of this study is to evaluate the Pharmacokinetics of lacosamide in children with epilepsy, aged 1 month to 17 years.
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Protection of trial subjects |
Informed consent were obtained from the subject’s parent/ legal guardian and documented in accordance with local regulations, ICH-GCP requirements, and the ethical principles that have their origin in the principles of the Declaration of Helsinki. When possible or as required by the local IRB/IEC, assent was obtained from the subject. Prior to obtaining informed consent, information was given in a language and at a level of complexity understandable to the subject and/ or the subject’s parent/legal guardian in both oral and written form by the investigator or designee. Each subject and/or subject’s parent/legal guardian had the opportunity to discuss the study and its alternatives with the investigator.
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Background therapy |
Subject had been prescribed LCM for the treatment of epilepsy for at least 1 month prior to Screening and had not been prescribed or maintained on LCM for the purposes of participating in this study. Lacosamide dose was stable for at least 7 days, and intake of the prescribed total daily dose confirmed for at least 3 days prior to participation. Subject was on a stable AED dosage regimen. The daily dosage regimen of concomitant AED(s) therapy must have been kept stable for a period of at least 1 week (7 days) prior to participation. | ||
Evidence for comparator |
Not Applicable | ||
Actual start date of recruitment |
11 Apr 2011
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Long term follow-up planned |
No
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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: 32
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Worldwide total number of subjects |
32
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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) |
2
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Children (2-11 years) |
21
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Adolescents (12-17 years) |
9
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Adults (18-64 years) |
0
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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 |
Recruitment for the SP1047 study began in April 2011. The overall study concluded in July 2014. This was a multicenter study with subjects enrolled by 9 sites across the United States of America. | ||||||
Pre-assignment
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Screening details |
The SP1047 study screened 34 patients. Out of the 34 patients, 2 subjects failed screening. This led to 32 subjects entering the SP1047 study. | ||||||
Period 1
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Period 1 title |
Overall Study Population (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
Not Applicable
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Arms
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Arm title
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Lacosamide, Commercially Available | ||||||
Arm description |
Male or female subjects (1 month to 17 years of age) who had been prescribed LCM for the treatment of epilepsy for at least 1 month prior to Screening. | ||||||
Arm type |
Commercially available | ||||||
Investigational medicinal product name |
Commercially available, prescribed lacosamide
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Investigational medicinal product code |
SPM927
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Other name |
VIMPAT
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Pharmaceutical forms |
Oral solution, Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Active substance: Lacosamide
Pharmaceutical form: Tablet and oral solution
Concentration: Tablets: 50 mg, 100 mg, 150 mg 200 mg, or Oral solution: 10 mg/ml
Route of Administration: Oral
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study Population
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Lacosamide, Commercially Available
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Reporting group description |
Male or female subjects (1 month to 17 years of age) who had been prescribed LCM for the treatment of epilepsy for at least 1 month prior to Screening. |
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End point title |
The total number of subjects experiencing at least one Adverse Event (AE) during the study [1] | ||||||
End point description |
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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End point type |
Primary
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End point timeframe |
AEs began to be collected at Screening and lasted through the Follow-up Period (approximately 19 days).
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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: Descriptive statistics (number and percentage of subjects) were presented for the primary safety outcome. |
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Notes [2] - Analysis group: Safety Set (SS). |
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No statistical analyses for this end point |
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End point title |
The total number of subject withdrawal due to at least one Adverse Event (AE) during the study [3] | ||||||
End point description |
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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End point type |
Primary
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End point timeframe |
AEs began to be collected at Screening and lasted through the Follow-up Period (approximately 19 days).
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Notes [3] - 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: Descriptive statistics (number and percentage of subjects) were presented for the primary safety outcome. |
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Notes [4] - Analysis group: Safety Set (SS). |
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No statistical analyses for this end point |
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End point title |
The total number of subjects experiencing at least one Serious Adverse Event (SAE) during the study [5] | ||||||
End point description |
An SAE meets 1 or more of the following criteria:
-Death
-Life-threatening
-Significant or persistent disability/ incapacity
-Congenital anomaly/ birth defect
-Important medical event based upon appropriate medical judgment, may jeopardize the patient and may require medical or surgical intervention to prevent one of the other outcomes listed in the definition of serious
-Initial inpatient hospitalization or prolonged hospitalization
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End point type |
Primary
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End point timeframe |
SAEs began to be collected at Screening and lasted through the Follow-up Period (approximately 19 days).
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Notes [5] - 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: Descriptive statistics (number and percentage of subjects) were presented for the primary safety outcome. |
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Notes [6] - Analysis group: Safety Set (SS). |
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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 (AEs) began to be collected at Screening and lasted through the Follow-up Period (approximately 19 days).
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Adverse event reporting additional description |
Adverse event reporting consists of the Safety Set (SS). The SS consists of all subjects who signed the informed consent form and took a dose of their prescribed LCM in the presence of study personnel. There were no Serious Adverse Events (SAEs) reported during the study.
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Assessment type |
Non-systematic | ||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||
Dictionary version |
16.1
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Reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
Adverse event reporting consists of the Safety Set (SS). The SS consists of all subjects who signed the informed consent form and took a dose of their prescribed LCM in the presence of study personnel. There were no Serious Adverse Events (SAEs) reported during the study. | ||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||
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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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08 Apr 2011 |
The primary purpose of this substantial amendment was to introduce the stratification of subjects by age category to ensure that an appropriate number of subjects were included in each age range. This stratification was based on recommendations received from the United States' Federal Drug Administration (FDA) at a Type C meeting held on 07 Mar 2011. |
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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. | |||
Study SP1047 was terminated prematurely as sufficient pharmacokinetic data had been collected to determine the dosing scheme for subsequent studies. | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/23859801 |