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Trial record 14 of 83 for:    CARBAMAZEPINE AND Cytochrome P-450 CYP3A Inducers

Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older (SP0993)

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: NCT01243177
Recruitment Status : Completed
First Posted : November 18, 2010
Results First Posted : February 23, 2016
Last Update Posted : July 18, 2018
Sponsor:
Collaborator:
Eden Sarl
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Epilepsy
Monotherapy
Interventions Drug: Lacosamide
Drug: Carbamazepine-Controlled Release
Enrollment 888
Recruitment Details This study started to enroll in April 2011 and concluded in August 2015.
Pre-assignment Details Participant Flow refers to the Safety Analysis Set which is defined as all randomized subjects who took at least 1 dose of study medication and is identical with the Full Analysis Set.
Arm/Group Title Lacosamide Carbamazepine-Controlled Release (CBZ-CR)
Hide Arm/Group Description
  • Strengths: 50 mg / 100 mg
  • Form: tablets
  • Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
  • Duration: up to 118 weeks
  • Strengths: 200 mg
  • Form: tablets
  • Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
  • Duration: up to 118 weeks
Period Title: Overall Study
Started 444 442
Completed 266 264
Not Completed 178 178
Reason Not Completed
Lack of Efficacy             47             31
Protocol Violation             11             10
Lost to Follow-up             15             18
Withdrawal by Subject             46             38
AE, serious fatal             0             1
SAE, non-fatal             7             9
AE, non-serious non-fatal             40             58
SAE, fatal + SAE, non-fatal             1             0
SAE,non-fatal+AE,non-serious non-fatal             0             1
Other Reason             11             12
Arm/Group Title Lacosamide Carbamazepine-Controlled Release (CBZ-CR) Total Title
Hide Arm/Group Description
  • Strengths: 50 mg / 100 mg
  • Form: tablets
  • Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
  • Duration: up to 118 weeks
  • Strengths: 200 mg
  • Form: tablets
  • Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
  • Duration: up to 118 weeks
[Not Specified]
Overall Number of Baseline Participants 444 442 886
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Analysis Set which is defined as all randomized subjects who took at least 1 dose of study medication and is identical with the Full Analysis Set.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 444 participants 442 participants 886 participants
<=18 years
27
   6.1%
19
   4.3%
46
   5.2%
Between 18 and 65 years
355
  80.0%
366
  82.8%
721
  81.4%
>=65 years
62
  14.0%
57
  12.9%
119
  13.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 444 participants 442 participants 886 participants
41.9  (17.9) 41.8  (17.2) 41.8  (17.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 444 participants 442 participants 886 participants
Female
201
  45.3%
210
  47.5%
411
  46.4%
Male
243
  54.7%
232
  52.5%
475
  53.6%
1.Primary Outcome
Title Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject
Hide Description The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.
Time Frame 6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication.
Arm/Group Title Lacosamide Carbamazepine-Controlled Release (CBZ-CR)
Hide Arm/Group Description:
  • Strengths: 50 mg / 100 mg
  • Form: tablets
  • Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
  • Duration: up to 118 weeks
  • Strengths: 200 mg
  • Form: tablets
  • Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
  • Duration: up to 118 weeks
Overall Number of Participants Analyzed 444 442
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
89.8
(86.8 to 92.8)
91.1
(88.2 to 94.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lacosamide, Carbamazepine-Controlled Release (CBZ-CR)
Comments This was a noninferiority assessment of Lacosamide versus Carbamazepine-CR for the proportion of subjects remaining seizure free for 6 months at the last evaluated dose.
Type of Statistical Test Non-Inferiority or Equivalence
Comments

The hypothesis was as follows:

H0: [S(t)LCM] – [S(t)CBZ-CR] ≤ -12 % versus HA: [S(t)LCM] - [S(t)CBZ-CR] > -12 %, where S(t) (t= 182 days) is the cumulative rate of subjects remaining seizure free for 6 months following stabilization at the last evaluated dose (also known as the survivorship function), and -12 % represents the noninferiority margin based on absolute difference.

Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mantel Haenszel
Comments The analysis was stratified based on the number of seizures in the 3 months preceding enrollment (≤ 2 and >2).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-5.5 to 2.8
Estimation Comments The lower limit of the confidence interval was >-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was >- 20 %.
2.Primary Outcome
Title Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject
Hide Description The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.
Time Frame 6 consecutive months (26 consecutive weeks) of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol Set (PPS) was defined as containing all subjects in the Full Analysis Set (FAS) who did not have any important protocol deviations determined to impact the interpretation of primary efficacy.
Arm/Group Title Lacosamide Carbamazepine-Controlled Release (CBZ-CR)
Hide Arm/Group Description:
  • Strengths: 50 mg / 100 mg
  • Form: tablets
  • Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
  • Duration: up to 118 weeks
  • Strengths: 200 mg
  • Form: tablets
  • Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
  • Duration: up to 118 weeks
Overall Number of Participants Analyzed 408 397
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
91.4
(88.5 to 94.3)
92.8
(90.1 to 95.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lacosamide, Carbamazepine-Controlled Release (CBZ-CR)
Comments This was a noninferiority assessment of Lacosamide versus Carbamazepine-CR for the proportion of subjects remaining seizure free for 6 months at the last evaluated dose.
Type of Statistical Test Non-Inferiority or Equivalence
Comments

The hypothesis was as follows:

H0: [S(t)LCM] – [S(t)CBZ-CR] ≤ -12 % versus HA: [S(t)LCM] - [S(t)CBZ-CR] > -12 %, where S(t) (t= 182 days) is the cumulative rate of subjects remaining seizure free for 6 months following stabilization at the last evaluated dose (also known as the survivorship function), and -12 % represents the noninferiority margin based on absolute difference.

Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mantel Haenszel
Comments The analysis was stratified based on the number of seizures in the 3 months preceding enrollment (≤ 2 and >2).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-5.3 to 2.7
Estimation Comments The lower limit of the confidence interval was >-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was >- 20 %.
3.Primary Outcome
Title Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)
Hide Description An Adverse Event 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, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.
Time Frame Duration of the Treatment Phase (up to 113 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
Arm/Group Title Lacosamide Carbamazepine-Controlled Release (CBZ-CR)
Hide Arm/Group Description:
  • Strengths: 50 mg / 100 mg
  • Form: tablets
  • Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
  • Duration: up to 118 weeks
  • Strengths: 200 mg
  • Form: tablets
  • Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
  • Duration: up to 118 weeks
Overall Number of Participants Analyzed 444 442
Measure Type: Number
Unit of Measure: Participants
328 332
4.Primary Outcome
Title Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)
Hide Description An Adverse Event 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, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.
Time Frame Duration of the Treatment Phase (up to 113 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
Arm/Group Title Lacosamide Carbamazepine-Controlled Release (CBZ-CR)
Hide Arm/Group Description:
  • Strengths: 50 mg / 100 mg
  • Form: tablets
  • Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
  • Duration: up to 118 weeks
  • Strengths: 200 mg
  • Form: tablets
  • Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
  • Duration: up to 118 weeks
Overall Number of Participants Analyzed 444 442
Measure Type: Number
Unit of Measure: Participants
47 69
5.Primary Outcome
Title Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)
Hide Description

An Adverse Event 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, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

A Serious Adverse Event must meet 1 or more predefined criteria like death, life-threatening, etc. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.

Time Frame Duration of the Treatment Phase (up to 113 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
Arm/Group Title Lacosamide Carbamazepine-Controlled Release (CBZ-CR)
Hide Arm/Group Description:
  • Strengths: 50 mg / 100 mg
  • Form: tablets
  • Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
  • Duration: up to 118 weeks
  • Strengths: 200 mg
  • Form: tablets
  • Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
  • Duration: up to 118 weeks
Overall Number of Participants Analyzed 444 442
Measure Type: Number
Unit of Measure: Participants
32 43
6.Secondary Outcome
Title Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject
Hide Description The proportion of subjects remaining seizure free for 12 months (52 weeks) was estimated using Kaplan-Meier methods.
Time Frame 12 consecutive months of treatment following stabilization at the last evaluated dose for each subject
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication.
Arm/Group Title Lacosamide Carbamazepine-Controlled Release (CBZ-CR)
Hide Arm/Group Description:
  • Strengths: 50 mg / 100 mg
  • Form: tablets
  • Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
  • Duration: up to 118 weeks
  • Strengths: 200 mg
  • Form: tablets
  • Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
  • Duration: up to 118 weeks
Overall Number of Participants Analyzed 444 442
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
77.8
(73.4 to 82.2)
82.7
(78.5 to 86.8)
Time Frame Adverse Events were collected during the whole study from Screening Phase (Week 0) over Evaluation, Maintenance and End of Study Phase up to 121 weeks.
Adverse Event Reporting Description Adverse Events refer to the Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.
 
Arm/Group Title Lacosamide Carbamazepine-Controlled Release (CBZ-CR)
Hide Arm/Group Description
  • Strengths: 50 mg / 100 mg
  • Form: tablets
  • Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
  • Duration: up to 118 weeks
  • Strengths: 200 mg
  • Form: tablets
  • Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
  • Duration: up to 118 weeks
All-Cause Mortality
Lacosamide Carbamazepine-Controlled Release (CBZ-CR)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lacosamide Carbamazepine-Controlled Release (CBZ-CR)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/444 (8.11%)      46/442 (10.41%)    
Blood and lymphatic system disorders     
Antiphospholipid syndrome * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Aplastic anaemia * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Cardiac disorders     
Atrial fibrillation * 1  1/444 (0.23%)  1 1/442 (0.23%)  1
Angina pectoris * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Cardiac failure * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Sinus tachycardia * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Ventricular extrasystoles * 1  1/444 (0.23%)  2 0/442 (0.00%)  0
Atrioventricular block first degree * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Pericardial haemorrhage * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Ear and labyrinth disorders     
Deafness unilateral * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Endocrine disorders     
Addison's disease * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Hyperthyroidism * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Gastrointestinal disorders     
Hernial eventration * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Dyspepsia * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Inguinal hernia * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
General disorders     
Gait disturbance * 1  2/444 (0.45%)  2 0/442 (0.00%)  0
Oedema peripheral * 1  1/444 (0.23%)  1 1/442 (0.23%)  1
Fatigue * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Inflammation * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Pyrexia * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Hepatobiliary disorders     
Cholelithiasis * 1  1/444 (0.23%)  1 1/442 (0.23%)  1
Cholecystitis acute * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Immune system disorders     
Hypersensitivity * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Infections and infestations     
Pneumonia * 1  1/444 (0.23%)  1 1/442 (0.23%)  1
Appendicitis * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Bronchitis * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Dengue fever * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Gastroenteritis * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Peritonsillar abscess * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Pyelonephritis acute * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Sinusitis * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Tuberculous pleurisy * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Vestibular neuronitis * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Injury, poisoning and procedural complications     
Tendon rupture * 1  2/444 (0.45%)  2 0/442 (0.00%)  0
Fall * 1  1/444 (0.23%)  1 1/442 (0.23%)  1
Post procedural complication * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Road traffic accident * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Skin injury * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Skull fracture * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Ulna fracture * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Accident * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Alcohol poisoning * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Craniocerebral injury * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Femur fracture * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Rib fracture * 1  0/444 (0.00%)  0 1/442 (0.23%)  2
Thoracic vertebral fracture * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Upper limb fracture * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Investigations     
Smear cervix abnormal * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Urine albumin/creatinine ratio increased * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Alanine aminotransferase increased * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Aspartate aminotransferase increased * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Gamma-glutamyltransferase increased * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Musculoskeletal and connective tissue disorders     
Lumbar spinal stenosis * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Osteoarthritis * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Rotator cuff syndrome * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acoustic neuroma * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Anaplastic astrocytoma * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Bladder cancer * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Nervous system disorders     
Convulsion * 1  4/444 (0.90%)  4 2/442 (0.45%)  3
Complex partial seizures * 1  2/444 (0.45%)  2 1/442 (0.23%)  1
Epilepsy * 1  2/444 (0.45%)  3 0/442 (0.00%)  0
Headache * 1  1/444 (0.23%)  1 1/442 (0.23%)  1
Dyskinesia * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Motor neurone disease * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Orthostatic intolerance * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Preictal state * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Subarachnoid haemorrhage * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Syncope * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Partial seizures with secondary generalisation * 1  0/444 (0.00%)  0 3/442 (0.68%)  3
Cerebrovascular accident * 1  0/444 (0.00%)  0 2/442 (0.45%)  2
Grand mal convulsion * 1  0/444 (0.00%)  0 2/442 (0.45%)  2
Ischaemic stroke * 1  0/444 (0.00%)  0 2/442 (0.45%)  2
Psychomotor hyperactivity * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Transient ischaemic attack * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Trigeminal nerve disorder * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Psychiatric disorders     
Aggression * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Agitation * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Suicidal ideation * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Suicide attempt * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Renal and urinary disorders     
Urinary incontinence * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Stress urinary incontinence * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Reproductive system and breast disorders     
Metrorrhagia * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Dyspnoea exertional * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Dyspnoea paroxysmal nocturnal * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Skin and subcutaneous tissue disorders     
Rash macular * 1  1/444 (0.23%)  1 0/442 (0.00%)  0
Drug reaction with eosinophilia and systemic symptoms * 1  0/444 (0.00%)  0 2/442 (0.45%)  2
Dermatitis allergic * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Rash generalised * 1  0/444 (0.00%)  0 1/442 (0.23%)  1
Vascular disorders     
Hypertension * 1  0/444 (0.00%)  0 1/442 (0.23%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide Carbamazepine-Controlled Release (CBZ-CR)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   165/444 (37.16%)      181/442 (40.95%)    
Gastrointestinal disorders     
Nausea * 1  26/444 (5.86%)  32 23/442 (5.20%)  30
General disorders     
Fatigue * 1  34/444 (7.66%)  38 49/442 (11.09%)  55
Infections and infestations     
Nasopharyngitis * 1  29/444 (6.53%)  42 29/442 (6.56%)  37
Investigations     
Gamma-glutamyltransferase increased * 1  7/444 (1.58%)  8 35/442 (7.92%)  36
Nervous system disorders     
Headache * 1  60/444 (13.51%)  82 58/442 (13.12%)  78
Dizziness * 1  53/444 (11.94%)  61 41/442 (9.28%)  52
Somnolence * 1  27/444 (6.08%)  28 41/442 (9.28%)  47
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA16.1
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB (Study Director)
Organization: UCB Cares
Phone: +1 887 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01243177     History of Changes
Other Study ID Numbers: SP0993
2010-019765-28 ( EudraCT Number )
First Submitted: November 16, 2010
First Posted: November 18, 2010
Results First Submitted: January 25, 2016
Results First Posted: February 23, 2016
Last Update Posted: July 18, 2018