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Trial record 2 of 2 for:    NCT01465997

A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994

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ClinicalTrials.gov Identifier: NCT02582866
Recruitment Status : Completed
First Posted : October 21, 2015
Results First Posted : January 22, 2021
Last Update Posted : August 17, 2021
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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 106
Recruitment Details The study started to enroll study participants in January 2016 and concluded in January 2020.
Pre-assignment Details Participant Flow refers to the Safety Set.
Arm/Group Title Lacosamide
Hide Arm/Group Description

Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.

Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks.

Period Title: Overall Study
Started 106
Completed 84
Not Completed 22
Reason Not Completed
Death             1
Lack of Efficacy             2
Lost to Follow-up             2
Withdrawal by Subject             7
Investigator decision             5
Participant wants to get pregnant             1
Pregnancy             2
Sponsor decision             1
Withdrawal due to personal reasons             1
Arm/Group Title Lacosamide
Hide Arm/Group Description

Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.

Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks.

Overall Number of Baseline Participants 106
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set (SS) which consisted of all study participants in the Enrolled Set (ES) who received at least 1 dose of study medication in SP1042.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants
<=18 years
2
   1.9%
Between 18 and 65 years
90
  84.9%
>=65 years
14
  13.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants
43.5  (17.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants
Female
48
  45.3%
Male
58
  54.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants
Asian
19
  17.9%
White
86
  81.1%
Other/Mixed
1
   0.9%
1.Primary Outcome
Title Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Time Frame From Visit 1 (Week 0) to Final Visit (up to Week 158)
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042.
Arm/Group Title Lacosamide (SS)
Hide Arm/Group Description:

Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.

Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks.

Participants formed the Safety Set (SS).

Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: percentage of participants
59.4
2.Primary Outcome
Title Percentage of Participants That Withdrew Due to Adverse Events (AEs)
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Time Frame From Visit 1 (Week 0) to Final Visit (up to Week 158)
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042.
Arm/Group Title Lacosamide (SS)
Hide Arm/Group Description:

Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.

Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks.

Participants formed the Safety Set (SS).

Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: percentage of participants
0.9
3.Primary Outcome
Title Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
Hide Description

A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires in patient hospitalization or prolongation of existing hospitalization
  • Is a congenital anomaly or birth defect
  • Is an infection that requires treatment parenteral antibiotics
  • Other important medical events which based on medical or scientific judgement may jeopardize the study participants, or may require medical or surgical intervention to prevent any of the above.
Time Frame From Visit 1 (Week 0) to Final Visit (up to Week 158)
Hide Outcome Measure Data
Hide Analysis Population Description
The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042.
Arm/Group Title Lacosamide (SS)
Hide Arm/Group Description:

Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.

Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks.

Participants formed the Safety Set (SS).

Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: percentage of participants
14.2
Time Frame Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lacosamide (SS)
Hide Arm/Group Description

Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.

Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks.

Participants formed the Safety Set (SS).

All-Cause Mortality
Lacosamide (SS)
Affected / at Risk (%)
Total   1/106 (0.94%)    
Hide Serious Adverse Events
Lacosamide (SS)
Affected / at Risk (%) # Events
Total   15/106 (14.15%)    
Cardiac disorders   
Atrial Flutter * 1  1/106 (0.94%)  1
Cardiac Failure * 1  1/106 (0.94%)  1
Myocardial Infarction * 1  1/106 (0.94%)  1
Ventricular Tachycardia * 1  1/106 (0.94%)  1
Gastrointestinal disorders   
Diarrhoea * 1  1/106 (0.94%)  1
Gastrooesophageal Reflux Disease * 1  1/106 (0.94%)  1
Umbilical Hernia * 1  1/106 (0.94%)  1
General disorders   
Device Dislocation * 1  1/106 (0.94%)  1
Sudden Unexplained Death In Epilepsy * 1  1/106 (0.94%)  1
Injury, poisoning and procedural complications   
Forearm Fracture * 1  1/106 (0.94%)  1
Post Gastric Surgery Syndrome * 1  1/106 (0.94%)  1
Tibia Fracture * 1  1/106 (0.94%)  1
Investigations   
Arteriogram Coronary * 1  1/106 (0.94%)  1
Metabolism and nutrition disorders   
Hypoglycaemia * 1  1/106 (0.94%)  1
Musculoskeletal and connective tissue disorders   
Osteoarthritis * 1  2/106 (1.89%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast Cancer * 1  1/106 (0.94%)  1
Nervous system disorders   
Epilepsy * 1  2/106 (1.89%)  2
Ischaemic Stroke * 1  1/106 (0.94%)  1
Peripheral Sensorimotor Neuropathy * 1  1/106 (0.94%)  1
Respiratory, thoracic and mediastinal disorders   
Acute Respiratory Distress Syndrome * 1  1/106 (0.94%)  1
Dyspnoea * 1  1/106 (0.94%)  1
Surgical and medical procedures   
Knee Arthroplasty * 1  1/106 (0.94%)  1
1
Term from vocabulary, MedDRA16.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide (SS)
Affected / at Risk (%) # Events
Total   19/106 (17.92%)    
Infections and infestations   
Nasopharyngitis * 1  8/106 (7.55%)  17
Nervous system disorders   
Headache * 1  11/106 (10.38%)  11
1
Term from vocabulary, MedDRA16.1
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma S.P.R.L. )
ClinicalTrials.gov Identifier: NCT02582866    
Other Study ID Numbers: SP1042
2015-001549-96 ( EudraCT Number )
First Submitted: October 20, 2015
First Posted: October 21, 2015
Results First Submitted: January 4, 2021
Results First Posted: January 22, 2021
Last Update Posted: August 17, 2021