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An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT00237458
Recruitment Status : Completed
First Posted : October 12, 2005
Results First Posted : May 15, 2012
Last Update Posted : August 28, 2017
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 Chronic Refractory Neuropathic Pain
Intervention Drug: Lacosamide
Enrollment 7
Recruitment Details The study started in May 2001 with subjects from Germany. The primary completion date and study completion date occurred in March 2011.
Pre-assignment Details One subject was discontinued on the study due to the Adverse Event of Vertigo. However, the Termination page of the Case Report Form reflected that the subject withdrew consent. Therefore, the Participant Flow will reflect 3 subjects did not complete the study, while the subjects withdrawing from Adverse Events will reflect 2.
Arm/Group Title Lacosamide
Hide Arm/Group Description Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Period Title: Overall Study
Started 7
Completed 4
Not Completed 3
Reason Not Completed
Lack of Efficacy             1
Adverse Event             1
Withdrawal by Subject             1
Arm/Group Title Lacosamide
Hide Arm/Group Description Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
47.4  (10.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
4
  57.1%
Male
3
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 7 participants
7
1.Primary Outcome
Title Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.
Hide Description [Not Specified]
Time Frame From Baseline Visit to Final Week of Treatment (approximately 10 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
7
2.Primary Outcome
Title Number of Subjects Withdrawing From Study Due To A Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.
Hide Description [Not Specified]
Time Frame From Baseline Visit to Final Week of Treatment (approximately 10 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
2
3.Secondary Outcome
Title Within-Subject Change In Average Daily Pain Score During the Treatment Period.
Hide Description The Average Daily Pain Score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame From Baseline Visit to Final Week of Treatment (approximately 9 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.9  (3.38)
4.Secondary Outcome
Title Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting.
Hide Description Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame From Baseline Visit to Final Week of Treatment (approximately 9 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.3  (4.27)
5.Secondary Outcome
Title Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Burning.
Hide Description Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame From Baseline Visit to Final Week of Treatment (approximately 9 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.4  (2.15)
6.Secondary Outcome
Title Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Paraesthesiae.
Hide Description Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame From Baseline Visit to Final Week of Treatment (approximately 9 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.1  (3.34)
7.Secondary Outcome
Title Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness.
Hide Description Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame From Baseline Visit to Final Week of Treatment (approximately 9 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.4  (3.78)
8.Secondary Outcome
Title Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Allodynia.
Hide Description

Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).

Allodynia is defined as neuropathic pain caused by normally innocuous stimuli becoming painful.
Time Frame From Baseline Visit to Final Week of Treatment (approximately 9 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.6  (2.37)
9.Secondary Outcome
Title Subject's Global Impression of Change In Pain During The Treatment Period.
Hide Description

The Subject's Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:

  1. Much better
  2. Moderately better
  3. Mildly better
  4. No change
  5. Mildly worse
  6. Moderately worse
  7. Much worse
Time Frame From Baseline Visit to Final Week of Treatment (approximately 9 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: percentage of participants
Better 85.7
No Change 14.3
Worse 0
10.Secondary Outcome
Title Investigator's Global Impression of Change In Pain During The Treatment Period.
Hide Description

The Investigator's Global Impression of Change is a physician's assessment of the patient's overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:

  1. Much better
  2. Moderately better
  3. Mildly better
  4. No change
  5. Mildly worse
  6. Moderately worse
  7. Much worse
Time Frame From Baseline Visit to Final Week of Treatment (approximately 9 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 7 subjects in the Safety Set (SS), 7 are included in this analysis.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: percentage of participants
Better 85.7
No Change 14.3
Worse 0
11.Secondary Outcome
Title Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Baseline Phase.
Hide Description

The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).

The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.

Summary statistics include mean and standard deviation.
Time Frame Baseline Period (approximately 1 week)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 7 subjects in the Safety Set (SS), 4 are included in this analysis.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: percentage of days
100  (0.00)
12.Secondary Outcome
Title Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration Phase.
Hide Description

The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).

The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.

Summary statistics include mean and standard deviation.
Time Frame Titration Period (approximately 6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 7 subjects in the Safety Set (SS), 4 are included in this analysis.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: percentage of days
51.3  (36.98)
13.Secondary Outcome
Title Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration and Treatment Phases.
Hide Description

The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).

The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.

Summary statistics include mean and standard deviation.
Time Frame From Titration Phase through Treatment Phase (approximately 9 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 7 subjects in the Safety Set (SS), 5 are included in this analysis.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: percentage of days
12.3  (7.91)
Time Frame The Time Frame for Adverse Event Reporting was the maximum exposure time of 9.5 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lacosamide
Hide Arm/Group Description Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
All-Cause Mortality
Lacosamide
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Lacosamide
Affected / at Risk (%) # Events
Total   4/7 (57.14%)    
General disorders   
Chest Pain * 1  1/7 (14.29%)  1
Pain * 1  1/7 (14.29%)  1
Injury, poisoning and procedural complications   
Femur Fracture * 1  1/7 (14.29%)  1
Investigations   
Weight Decreased * 1  1/7 (14.29%)  1
Nervous system disorders   
Syncope * 2  1/7 (14.29%)  1
Vascular disorders   
Circulatory Collapse * 1  1/7 (14.29%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 9.1
2
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   7/7 (100.00%)    
Cardiac disorders   
Sinus Bradycardia * 1  1/7 (14.29%)  1
Sinus Tachycardia * 1  1/7 (14.29%)  1
Ear and labyrinth disorders   
Vertigo * 1  1/7 (14.29%)  1
Eye disorders   
Conjunctival Haemorrhage * 1  1/7 (14.29%)  1
Iritis * 1  1/7 (14.29%)  1
Gastrointestinal disorders   
Diarrhoea * 1  2/7 (28.57%)  2
Enterocolitis Haemorrhagic * 1  1/7 (14.29%)  1
Peptic Ulcer * 1  1/7 (14.29%)  1
Stomach discomfort * 1  1/7 (14.29%)  1
Vomiting * 1  1/7 (14.29%)  1
General disorders   
Asthenia * 1  1/7 (14.29%)  1
Fatigue * 1  2/7 (28.57%)  2
Infections and infestations   
Gastroenteritis * 1  1/7 (14.29%)  3
Influenza * 1  2/7 (28.57%)  3
Localised Infection * 1  1/7 (14.29%)  1
Lower Respiratory Tract Infection * 1  1/7 (14.29%)  1
Mumps * 1  1/7 (14.29%)  1
Nasopharyngitis * 1  1/7 (14.29%)  5
Pharyngitis * 1  2/7 (28.57%)  4
Sinusitis * 1  1/7 (14.29%)  2
Upper Respiratory Tract Infection * 1  3/7 (42.86%)  14
Viral Infection * 1  2/7 (28.57%)  3
Injury, poisoning and procedural complications   
Foot Fracture * 1  1/7 (14.29%)  1
Fractured Coccyx * 1  1/7 (14.29%)  1
Joint Sprain * 1  1/7 (14.29%)  1
Muscle Strain * 1  1/7 (14.29%)  1
Investigations   
Alanine Aminotransferase Increased * 1  1/7 (14.29%)  1
Aspartate Aminotransferase Increased * 1  1/7 (14.29%)  1
Basophil Count Increased * 1  1/7 (14.29%)  1
Blood Phosphorus Increased * 1  1/7 (14.29%)  1
Blood Sodium Decreased * 1  1/7 (14.29%)  1
Electrocardiogram QT Corrected Interval Prolonged * 1  1/7 (14.29%)  2
Electrocardiogram QT Prolonged * 1  1/7 (14.29%)  1
Gamma-glutamyltransferase Increased * 1  1/7 (14.29%)  2
Neutrophil Count Decreased * 1  3/7 (42.86%)  4
Platelet Count Decreased * 1  2/7 (28.57%)  4
Thyroxine Free Increased * 1  1/7 (14.29%)  1
Metabolism and nutrition disorders   
Diabetes Mellitus * 1  2/7 (28.57%)  2
Diabetes Mellitus Non-insulin-dependent * 1  1/7 (14.29%)  1
Hypercholesterolaemia * 1  1/7 (14.29%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/7 (14.29%)  2
Groin Pain * 1  1/7 (14.29%)  1
Muscle Spasms * 1  2/7 (28.57%)  2
Neck Pain * 1  1/7 (14.29%)  1
Pain In Extremity * 1  1/7 (14.29%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lipoma * 1  1/7 (14.29%)  1
Nervous system disorders   
Dizziness * 1  4/7 (57.14%)  5
Headache * 1  2/7 (28.57%)  9
Tension Headache * 1  1/7 (14.29%)  1
Psychiatric disorders   
Depression * 1  2/7 (28.57%)  2
Sleep disorder * 1  1/7 (14.29%)  1
Reproductive system and breast disorders   
Menorrhagia * 1  1/7 (14.29%)  3
Skin and subcutaneous tissue disorders   
Hyperhidrosis * 1  1/7 (14.29%)  1
Pruritus * 1  1/7 (14.29%)  1
Rash * 1  2/7 (28.57%)  2
Vascular disorders   
Hypertension * 1  2/7 (28.57%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
[Not Specified]
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: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Publications of Results:
McCleane G, Koch B, Rauschkolb C. Does SPM 927 have an analgesic effect in human neuropathic pain? An open label study. Neurosci Lett. 2003 Dec 4;352(2):117-20.
Shaibani A, Biton V, Rauck R, Koch B, Simpson J. Long-term oral lacosamide in painful diabetic neuropathy: a two-year open-label extension trial. Eur J Pain. 2009 May;13(5):458-63. doi: 10.1016/j.ejpain.2008.05.016. Epub 2008 Jul 10.
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00237458    
Other Study ID Numbers: SP0647
First Submitted: October 11, 2005
First Posted: October 12, 2005
Results First Submitted: March 7, 2012
Results First Posted: May 15, 2012
Last Update Posted: August 28, 2017