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eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam (VERVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01484977
Recruitment Status : Completed
First Posted : December 5, 2011
Results First Posted : November 26, 2014
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Lacosamide
Enrollment 120
Recruitment Details The recruitment for the SP0980 study began in December 2011. It concluded in January 2014. 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 Details The participant flow consists of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
Arm/Group Title Lacosamide
Hide Arm/Group Description

Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).

Lacosamide: 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. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.

Maximum duration of study drug administration is approximately 23 weeks.

Period Title: Overall Study
Started 120
Completed 93
Not Completed 27
Reason Not Completed
Adverse Event             8
Lack of Efficacy             4
Protocol Violation             6
Lost to Follow-up             1
Withdrawal by Subject             4
Subject Protocol Non-compliant             1
Moving Overseas             1
Low White Blood Cell Count             1
Lack of Compliance             1
Arm/Group Title Lacosamide
Hide Arm/Group Description

Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).

Lacosamide: 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. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.

Maximum duration of study drug administration is approximately 23 weeks.

Overall Number of Baseline Participants 120
Hide Baseline Analysis Population Description
The Baseline characteristics consist of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
<=18 years
1
   0.8%
Between 18 and 65 years
114
  95.0%
>=65 years
5
   4.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants
39.7  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants
Female
74
  61.7%
Male
46
  38.3%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 120 participants
76.39  (19.98)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 120 participants
168.02  (10.55)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kilogram/ square meter
Number Analyzed 120 participants
27.00  (6.45)
Racial Group  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants
American Indian/Alaskan Native 1
Asian 3
Black 8
Native Hawaiian or other Pacific Islander 0
White 96
Other/Mixed 12
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants
Hispanic or Latino 17
Not Hispanic or Latino 103
1.Primary Outcome
Title Retention at the End of the 21-week Treatment Period
Hide 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.
Time Frame Duration of the Treatment Period (21 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis consists of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
Arm/Group Title Lacosamide
Hide Arm/Group Description:

Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).

Lacosamide: 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. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.

Maximum duration of study drug administration is approximately 23 weeks.

Overall Number of Participants Analyzed 120
Measure Type: Number
Unit of Measure: percentage of participants
73.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lacosamide
Comments

Analyses of the primary efficacy variable will be descriptive only. No hypothesis tests are planned.

The number and percentage of subjects remaining in the study through the 21-Week Treatment Period will be calculated. Subjects with retention will be counted in the numerator. All subjects in the relevant population will be used as the denominator.

This percentage will be known as the retention rate, along with the 95 % confidence interval based on the normal approximation.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Retention Rate
Estimated Value 73.3
Confidence Interval (2-Sided) 95%
65.42 to 81.25
Estimation Comments [Not Specified]
Time Frame Treatment Emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in January 2014.
Adverse Event Reporting Description TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
 
Arm/Group Title Lacosamide
Hide Arm/Group Description

Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).

Lacosamide: 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. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.

Maximum duration of study drug administration is approximately 23 weeks.

All-Cause Mortality
Lacosamide
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Lacosamide
Affected / at Risk (%) # Events
Total   8/120 (6.67%)    
Blood and lymphatic system disorders   
Anaemia * 1  1/120 (0.83%)  1
Leukocytosis * 1  1/120 (0.83%)  1
Cardiac disorders   
Acute Myocardial Infarction * 1  1/120 (0.83%)  1
Angina Pectoris * 1  1/120 (0.83%)  1
Gastrointestinal disorders   
Toothache * 1  1/120 (0.83%)  1
Infections and infestations   
Pneumonia * 1  2/120 (1.67%)  2
Appendicitis * 1  1/120 (0.83%)  1
Infection * 1  1/120 (0.83%)  1
Urinary Tract Infection * 1  1/120 (0.83%)  1
Vulvovaginitis Trichomonal * 1  1/120 (0.83%)  1
Nervous system disorders   
Migraine * 1  1/120 (0.83%)  1
Psychiatric disorders   
Anxiety * 1  1/120 (0.83%)  1
Mental Status Changes * 1  1/120 (0.83%)  1
Suicidal Ideation * 1  1/120 (0.83%)  1
Reproductive system and breast disorders   
Asthma * 1  1/120 (0.83%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide
Affected / at Risk (%) # Events
Total   52/120 (43.33%)    
Gastrointestinal disorders   
Nausea * 1  7/120 (5.83%)  7
General disorders   
Fatigue * 1  10/120 (8.33%)  13
Nervous system disorders   
Dizziness * 1  28/120 (23.33%)  40
Headache * 1  18/120 (15.00%)  21
Convulsion * 1  7/120 (5.83%)  8
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01484977    
Other Study ID Numbers: SP0980
2011-002461-37 ( EudraCT Number )
First Submitted: December 1, 2011
First Posted: December 5, 2011
Results First Submitted: November 20, 2014
Results First Posted: November 26, 2014
Last Update Posted: July 18, 2018